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1.
Freeman, S. (2011). Improving cognitive treatments for
delusions. Schizophrenia Research, 132, (2–3), 135-139.
doi:10.1016/j.schres.2011.08.012
generation CBT for psychosis was successful but the strength of
the treatment was weak and as the author states similar to those
of clozapine (an antipsychotic used as a last resort for
psychosis). Therapy is not up to date as it should be for
delusions as delusion are understood quite well and therapy
needs to catch up. The treatment of CBT for psychosis is similar
to CBT treatment for anxiety.
Pay attention to single symptoms in psychosis
2.
Munro, Alistair (May 1992) Psychiatric Disorders Characterized
by Delusions: Treatment in Relation to Specific Types.
Psychiatric Annals, 22, 5, ProQuest Central pg. 232
3.
Ho-wai So, S., Roisin Peters, E., Swendsen, J., Garety, P.A., &
Kapur, S. (2014) Changes in delusions in the early phase of
antipsychotic treatment – An experience sampling study.
Psychiatry Research 215, 568-573
Summarize including the research question addressed in the
source, if applicable, and major findings.
Evaluate the usefulness of the source for your literature review,
making sure to directly state why the source is informative for
your specific topic
Three dimensions of delusions are always present in factor
analyses and they are a conviction, distress, preoccupation, and
disruption to life. More studies need to be done to learn how
delusions respond to antipsychotic. Conviction has been least
amenable to change shows the studies. Many studies ponder the
question, “why does conviction exist?” There have been studies
that show that reasoning bias including “Jumping to conclusion
(JTC)” bias and by patients being inflexible contributes to the
maintenance of delusions. JTC has also shown that the
dimension of conviction of delusions and the severity of
delusions is influenced by JTC. Delusions improve during the
first few weeks of treatment and some studies show
improvement in the first few hours.
It was hypothesized that delusion distress and preoccupation
would reduce significantly over two weeks of antipsychotic
treatment; but not a conviction. Female participants showed a
higher response on all four delusion dimensions compared to the
male participants. 57% of the participants showed the JTC bias.
The no-JTC group showed a larger improvement in conviction
and distress and with their delusions in general.
This study is important for my literature review and further
studies because the three dimensions of delusions: distress,
preoccupation, and conviction are important for the clinical
implications of treatment. If we take into account these three
dimensions it will benefit further research and treatments.
4.
The efficacy of a new translational treatment for persecutory
delusions: study protocol for a randomized controlled trial (The
Feeling Safe Study)
Freeman et al. (2016) Trials, 17:134. doi:10.1186/s13063-016-
1245-0
Summarize including the research question addressed in the
source, if applicable, and major findings.
Evaluate the usefulness of the source for your literature review,
making sure to directly state why the source is informative for
your specific topic
This study looks at how individuals with persecutory delusions,
unfounded beliefs, believe that others are trying to harm them.
We know that treatments for persecutory delusions need to be
improved. The first-line treatment is usually medication and this
has drawbacks as well: side effects, non-compliance, residual
symptoms. The author shows that the maintenance of
persecutory delusions has 6 components that we need to take
into account while treating delusions and they are: worry,
negative self-beliefs, unusual experiences, sleep dysfunction,
reasoning bias and safety behaviors. Treatment needs to target
these maintenance factors. The strongest test so far in the
literature has been in reducing worry where “The Worry
Intervention Trial” which took place with 150 patients and had
a 95% follow-up rate. At a 6 month follow up it showed that 2/3
of the reduction in the delusions that patients experienced were
due to a decrease in worry. Also increases in psychological
well-being and psychiatric symptoms. There was also a pilot
study that took place before the study that the authors did and
this study (The Self-Confidence Study) looked at 30 patients
who had persecutory delusions and increased positive self-
beliefs by using techniques to decrease negative self-beliefs.
The treatment had an effect size of 1.0 for positive self-beliefs
and 1.2 for psychological well-being, reductions in negative
self-beliefs 0.24 and the delusions 0.6.
Other studies have looked at 31 patients with persistent
delusions and used the treatment “Thinking Well” reasoning
intervention to reduce delusional conviction, effect size 0.6
compared to standard care.
5.
Vol. 32, No. 3, pp. 355-367, 1994
Chadwick, P.D.J. & Lowe, C.F. A cognitive approach to
measuring and modifying delusions. Behav. Res. Ther.
3 studies completed on the measurement and modification of
delusions in this study. The authors were influenced by verbal
self-regulation of behavior and Maher’s work where he stated
that a delusion experience.n was a normal attempt to make sense
of abnormal perceptual experience. The patients who are
distressed and puzzled over delusions try to make a meaningful
explanation for them. Maher said that the meaning people make
and the process they go through to get the meaning may not be
too different than that of a person who has a “normal belief.”
He said that” bizarre perceptions demand bizarre explanations.”
He says that delusions are rational for what the individual is
experiencing (auditory hallucination for example) and the
people are incorrect.
This study looked at paranoid, grandiose, control and identity
delusions. Recent studies show that people with delusions have
biased reasoning.
6. the effect of delusion and hallucination types on treatment
response in schizophrenia and schizoaffective disorder
This study looked at what effect the type of delusion and
hallucination had on the treatment response of 116 inpatients
all diagnosed with schizoaffective disorder. Religious and
delusions of poisoning the most commonly noted. Patients with
religious or grandiose delusions had the longest hospitalization
and patients with sexual, religious and grandiose delusions had
strong predictors for poor response to treatment. The same
patients were prescribed more antipsychotic drugs and social
functionality was less. Hallucinations did not affect therapy
however visual hallucinations correlated with disease scores
when patients were admitted.
7.Metacognitive Training for Delusion in Treatment-Resistant
Schizophrenia: A Case Report
People with schizophrenia have deficits in their metacognition,
or “thinking about thinking.” this case report is about a 34-year-
old woman with persecutory beliefs that did not respond to
several courses of antipsychotics meds and ECT therapy.
Metacognitive training was implanted between the patient and a
therapist. The patient learned how jumping to conclusions about
events without proper evidence could lead to an incorrect
explanation, how emotions of self and others could be
misinterpreted and how memory about something could get
distorted.
Usefulness for my Literature Review: I need to know if patients
have deficits in their metacognition and how it relates to
recovery.
8.
Virtual reality in the treatment of persecutory delusions:
randomized controlled experimental study testing how to reduce
the delusional conviction
See discussions, stats, and author profiles for this publication
at: https://www.researchgate.net/publication/297893567
The efficacy of a new translational treatment for persecutory
delusions: Study
protocol for a randomised controlled trial (The Feeling Safe
Study)
Article in Trials · December 2016
DOI: 10.1186/s13063-016-1245-0
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STUDY PROTOCOL Open Access
The efficacy of a new translational
treatment for persecutory delusions: study
protocol for a randomised controlled trial
(The Feeling Safe Study)
Daniel Freeman1*, Felicity Waite1, Richard Emsley2, David
Kingdon3, Linda Davies4, Ray Fitzpatrick5
and Graham Dunn2
Abstract
Background: Persecutory delusions (strong unfounded fears that
others intend harm to the person) occur in more
than 70 % of the patients diagnosed with schizophrenia. This
major psychotic experience is a key clinical target, for
which substantial improvement in treatment is needed. Our aim
is to use advances in theoretical understanding to
develop a much more efficacious treatment that leads to
recovery in at least 50 % of people with persistent
persecutory delusions. Our cognitive conceptualisation is that
persecutory delusions are threat beliefs, developed
in the context of genetic and environmental risk, maintained by
a number of psychological processes including
excessive worry, low self-confidence, intolerance of anxious
affect and other internal anomalous experiences,
reasoning biases, and safety-seeking strategies. The clinical
implication is that safety has to be relearned, by
entering the feared situations after reduction of the influence of
the maintenance factors. We have been individually
evaluating modules targeting causal factors. These will now be
tested together as a full treatment, called The Feeling
Safe Programme. The treatment is modular, personalised, and
includes patient preference. We will test whether the
new treatment leads to greater recovery in persistent
persecutory delusions, psychological well-being, and
activity levels compared to befriending (that is, controlling for
therapist attention).
Methods/design: The Feeling Safe Study is a parallel group
randomised controlled trial for 150 patients who have
persecutory delusions despite previous treatment in mental
health services. Patients will be randomised (1:1 ratio) to
The Feeling Safe Programme or befriending (both provided in
20 sessions over 6 months). Standard care will continue
as usual. Online randomisation will use a permuted blocks
algorithm, with randomly varying block size, stratified by
therapist. Assessments, by a rater blind to allocation, will be
conducted at 0, 6 (post treatment), and 12 months. The
primary outcome is the level of delusional conviction at 6
months. Secondary outcomes include levels of psychological
well-being, suicidal ideation, and activity. All main analyses
will be intention-to-treat. The trial is funded by the NHS
National Institute for Health Research.
Discussion: The Feeling Safe study will provide a Phase II
evaluation of a new targeted translational psychological
treatment for persecutory delusions.
Trial registration: Current Controlled Trials ISRCTN18705064
(registered 11 November 2015).
Keywords: Paranoia, persecutory delusions, schizophrenia,
psychosis, cognitive therapy
* Correspondence: [email protected]
1Department of Psychiatry, University of Oxford, Warneford
Hospital, Oxford
OX3 7JX, UK
Full list of author information is available at the end of the
article
© 2016 Freeman et al. Open Access This article is distributed
under the terms of the Creative Commons Attribution 4.0
International License
(http://creativecommons.org/licenses/by/4.0/), which permits
unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate
credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were
made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to
the data made available in this article, unless otherwise stated.
Freeman et al. Trials (2016) 17:134
DOI 10.1186/s13063-016-1245-0
http://crossmark.crossref.org/dialog/?doi=10.1186/s13063-016-
1245-0&domain=pdf
http://www.isrctn.com/ISRCTN18705064
mailto:[email protected]
http://creativecommons.org/licenses/by/4.0/
http://creativecommons.org/publicdomain/zero/1.0/
Background
Persecutory delusions, a central problem in schizophrenia,
are unfounded beliefs that others are trying to harm the
person [1]. Nearly half of patients with persecutory delu-
sions have major depression [2]. Persecutory delusions
predict serious violence [3], suicide [4], and hospital ad-
mission [5]. It is well-recognised that treatments for perse-
cutory delusions need significant improvement. The first
line treatment, medication has effect sizes (standardised
mean differences) varying between 0.33 and 0.88 (median
= 0.44) [6], with problems of major side effects, poor com-
pliance, and residual symptoms. In a review, Kennedy et
al. [7] found that ‘almost 60 % of patients failed to achieve
response after 23 weeks on antipsychotic drug therapy’.
Meta-analysis for first generation psychological treatment
(when added to medication) indicates an effect size of only
0.36 for delusions [8]. Psychological treatment is a valued
treatment choice for patients, but problems of availability
exist. For instance, in the United Kingdom only about
5 to 10 % of patients receive cognitive behavioural
therapy (CBT) for psychosis [9]. Using advances in the
understanding of the causes of persecutory delusions,
our team have been developing a new targeted modular
psychological treatment - called ‘The Feeling Safe
Programme’ - with the aim of improving efficacy and
deliverability.
The translational studies leading to the trial
At the core of a persecutory delusion is the belief that
the person is unsafe [10]. New research shows that the
heritability of paranoid thoughts is 50 % [11], indicating
genetic and environmental risk leading to such fears.
Once developed, the beliefs concerning danger are main-
tained by six key factors [12] (see Fig. 1). For example,
worry brings implausible ideas to mind, keeps them
there, and exacerbates the distress; negative self-beliefs
lead the person to feel inferior and vulnerable; subjectively
anomalous internal states (for example, dissociation, unex-
plained anxious arousal, and perceptual disturbances)
provoke fearful explanations; disrupted sleep increases
negative affect, mood dysregulation, and anomalous in-
ternal states; reasoning biases prevent the processing of
alternative explanations; and safety-seeking (defensive) be-
haviours such as avoidance prevent the person receiving
and processing disconfirmatory evidence that he or she is
safe. Therefore treatment needs to target the maintenance
factors before helping the patient to go into everyday situ-
ations and relearn that they are safe.
Our team have been developing and evaluating brief
treatments targeting these maintenance factors. Brief,
manualised interventions have been used in order to
aid the theoretical interpretation, later dissemination,
and the building of a combined treatment. The stron-
gest test has been for reducing worry. A randomised
controlled trial (‘The Worry Intervention Trial’) with
150 patients with persistent persecutory delusions was
completed [13]. This had blind ratings and a 95 %
follow-up rate. Targeting worry, in just six sessions,
significantly reduced both worry and the persecutory
delusions (both effect sizes = 0.5). A mediation analysis
Fig. 1 The maintenance of persecutory delusions [12]
Freeman et al. Trials (2016) 17:134 Page 2 of 8
showed that two-thirds of the reductions in the delu-
sions were due to reductions in worry. There were also
significant increases in psychological well-being and re-
ductions in overall psychiatric symptoms. A pilot ran-
domised controlled trial (‘The Self-Confidence Study’)
with 30 patients with persistent persecutory delusions,
principally used techniques to enhance positive self-beliefs
in order to limit the effects of negative self-beliefs [14].
Ratings were blind, and 100 % of the patients were
followed up. Post treatment improvements were ob-
served in positive self-beliefs (effect size = 1.0) and psy-
chological well-being (effect size = 1.2) and reductions
in negative self-beliefs (effect size = 0.24) and the delu-
sions (effect size = 0.6). An assessor-blind, pilot rando-
mised controlled trial (‘The Better Sleep Trial’) with 50
patients with persistent delusions and hallucinations
showed that sleep can be substantially improved (effect
size = 1.9) and that consequential benefits may exist in the
levels of paranoia (effect size = 0.2) and quality of life
(effect size = 0.5) [15]. A trial with several thousand uni-
versity students with insomnia is now underway that will
have sufficient power to test definitively the relation be-
tween sleep improvement and paranoia [16]. Two recent
randomised controlled studies have shown the benefits of
reducing reasoning biases in patients with delusions [17,
18]. For example, in a pilot clinical study with 31 patients
with persistent delusions, the ‘Thinking Well’ reasoning
intervention led to a reduction in delusional conviction
(effect size = 0.6) compared to standard care [18]. Most re-
cently, we have shown that going into feared situations
(that is, reducing avoidance) while dropping safety-seeking
behaviours that prevent the full processing of disconfirm-
atory evidence reduces delusions to a much greater extent
than exposure alone (effect size = 1.3) [19]. All these ele-
ments have now been combined as part of a full interven-
tion, called The Feeling Safe Programme, delivered in 20
sessions over 6 months. The feasibility of this treatment
has been recently established in a case series, and indica-
tions exist of substantial clinical benefits for the patients
[20]. The Feeling Safe Programme has been developed fur-
ther on the basis of this case series.
The new clinical trial
The primary aim now is to test the efficacy in a single
centre of this new theoretically-driven treatment for per-
secutory delusions. The target group is those at most
need: patients whose delusions have not responded to
current treatment. The Feeling Safe Programme is antici-
pated to lead to 50 % of patients having recovery in persist-
ent persecutory delusions. We will test the intervention
against an equal time receiving befriending (called ‘Feeling
Safe and Supported’) from the same therapists. Befriending
has benefits for patients with psychosis and in the
short-term is comparable to first-generation cognitive-
behavioural psychological therapies for psychosis [21, 22].
This choice of comparison allows us to determine whether
the Feeling Safe Programme has benefits over and above
the extra time spent with a therapist, which is important
to determine for future training needs and service
provision.
The primary outcome will be conviction in the perse-
cutory delusion, testing rates of recovery in the delu-
sions (defined as conviction falling below 50 %, that is,
greater doubt than certainty in the delusion) and di-
mensional reductions in conviction levels. The Feeling
Safe Programme is hypothesized to lead to lower levels
of conviction in the persecutory delusions compared to
befriending. Key secondary hypotheses are that the
Feeling Safe Programme, compared to befriending, will
lead to improved psychological well-being and activity
levels compared to befriending. The Feeling Safe
Programme, compared to befriending, is also predicted
to lead to lower levels of overall paranoia, total delusion
severity, and suicidal ideation. The primary endpoint
will be the 6-month outcomes (that is, post-treatment)
but the persistence of effects at a longer follow-up will
also be tested (12 months).
An explanatory component to the trial will be in-
cluded. We will test whether changes in key mainten-
ance factors (worry, self-beliefs, anomalous experiences,
sleep, reasoning, safety-seeking behaviours) mediate
change in delusions. We will also test whether working
memory, illicit drug use, and levels of anger moderate
treatment effects. We will record all service use, and
other relevant health economic data, in order to carry
out a health economic analysis.
Methods
The trial has received ethical approval from an NHS
Research Ethics Committee (South Central – Oxford B
Research Ethics Committee; ref 15/SC/0508) and has been
registered (Current Controlled Trials ISRCTN18705064).
Informed consent will be obtained from all participants. A
Data Monitoring and Ethics Committee (DMEC), Trial
Steering Committee (TSC), and Patient Advisory Group
(PAG) have been formed.
Design
The design is a parallel group randomised controlled
trial with single blind assessment to test whether the
new psychological treatment will reduce persecutory de-
lusions more effectively than befriending (an attention
control condition) (see Fig. 2). Standard care will be
measured but remain as usual in both groups. Assess-
ments will be carried out at 0, 6 (post treatment), and
12 months.
Freeman et al. Trials (2016) 17:134 Page 3 of 8
Participants
Participants will be sought who have persistent perse-
cutory delusions in the context of non-affective psych-
osis. The inclusion criteria are male or female, aged
16 years or above; persistent (at least 3 months) perse-
cutory delusion (as defined by Freeman and Garety [1]),
held with at least 60 % conviction; and primary diagno-
sis of schizophrenia-spectrum psychosis (non-affective
psychosis). The exclusion criteria are current receipt of
another psychological therapy; insufficient comprehen-
sion of English; primary diagnosis of alcohol, drug, or
personality disorder; in forensic settings; organic syn-
drome; or learning disability. Referrals will be sought
from Oxford Health NHS Foundation Trust and neigh-
bouring NHS Trusts (for example, Northamptonshire
Healthcare NHS Foundation Trust and Berkshire
Healthcare NHS Foundation Trust).
Randomisation and blinding
The trial assessor will be blind to group allocation, but
the patients and trial therapists will not be. Patient con-
sent and assessments will be carried out by the trial
assessor. Randomisation will occur after completion of
the baseline assessment. An online randomisation sys-
tem has been written by the University of Oxford Pri-
mary Care Clinical Trials Unit. Randomisation using a
permuted blocks algorithm, with randomly varying block
size, will be stratified by therapist. Therapists will provide
both interventions in order to reduce the confounding of
therapist effects and increase statistical power. The trial
co-ordinator will use the online system, after being pro-
vided by the trial assessor with basic patient details
(date of birth, gender).
The trial coordinator will inform trial therapists who
will then inform patients of the randomisation outcome,
so that the research assessors remain blind to group
allocation. Precautionary strategies to prevent breaks of
the blind include the following: the patients being
reminded by team members not to talk about treatment
allocation; the assessor not looking at the patient’s
clinical notes after the baseline assessment; and if an
allocation is revealed between assessment sessions, then
re-blinding with another assessor. We envisage conceal-
ment of treatment allocation from the trial assessor will
Fig. 2 Trial flow diagram
Freeman et al. Trials (2016) 17:134 Page 4 of 8
be easier than treatment-as-usual comparison trials be-
cause all patients are receiving a psychological interven-
tion from the same therapists.
Assessments
Basic demographic and clinical data will be collected (for
example, age, gender, ethnicity, and clinical diagnosis).
The primary outcome measure will be conviction in the
persecutory delusion (using a 0 to 100 % scale), assessed
within the Psychotic Symptoms Rating Scale-Delusions
scale [23]. Recovery is defined as the conviction in the de-
lusional belief falling below 50 %; that is, there is greater
doubt than belief in the delusion. Conviction greater than
50 % is a standard definition of the presence of a delusion
(for example, [24]), although such beliefs are typically held
with much greater certainty. For example, in our Feeling
Safe Programme pilot study (n = 12), the initial conviction
levels in the delusions showed a mean of 90 % (SD = 17)
[20], and in a previous study with 100 patients with delu-
sions, the mean conviction rating was 82 % (SD = 20) [25].
In the Worry Intervention Trial, at baseline, half of the
150 patients had 100 % conviction in the persecutory delu-
sions [13].
Psychological well-being will be assessed by the
Warwick-Edinburgh Mental Well-being Scale [26], health
status by the EQ-5D-5 L (see http://www.euroqol.org/),
quality of life by the Long Term Conditions Questionnaire
(LTCQ) [27], and patient satisfaction using an adapted
version of the CHOICE, a service user-led outcome meas-
ure [28]. Activity levels will be assessed using a step count
and a time-budget measure [29]. We will also include
measures of overall paranoia (Green et al. Paranoid
Thoughts Scale) [30], suicidal ideation (Columbia-Suicide
Severity Rating Scale) [31], and depression (Beck Depres-
sion Inventory) [32].
We will include the following as moderators: working
memory [33], illicit drug use [34], and anger (Dimen-
sions of Anger Reactions (DAR-5)) [35]. For mediation,
we will include the following: the Penn State Worry
Questionnaire [36], Brief Core Schema Scales [37],
Specific Psychotic Experiences Questionnaire - halluci-
nations subscale (SPEQ) [38], Insomnia Severity Index
[39], jumping to conclusions [40] and belief flexibility
[18], and the Safety Behaviours Questionnaire – Persecu-
tory Beliefs [41]. We will record service use and other
relevant health economic data using an adapted version of
the Economic Patient Questionnaire [42] (EPQ) that
includes questions from the Client Service Receipt
Inventory [43].
In collaboration with the McPin Foundation, qualita-
tive interviews will be carried out with a small number
of patients and family members about the Feeling Safe
Programme to assess the acceptability of the experimen-
tal intervention.
Adverse events
We will check medical notes at the end of a patient’s
participation for serious adverse events, including but not
limited to: 1. All deaths. 2. Suicide attempts. 3. Violent in-
cidents (needing police involvement) and 4. Formal com-
plaints about therapy. We will also record any such event
that we become aware of during a patient’s participation.
All hospital admission data will also be recorded. The
DMEC will determine relatedness of an event to the trial
based on a temporalrelationship and whether the event is
unexpected or unexplained given the participant’s clinical
course, previous history, and concomitant treatments.
Psychological interventions
Both treatments are provided to patients individually in
approximately 20 sessions over 6 months. Treatments will
be provided by the trial clinical psychologists, with weekly
supervision. The number of sessions and length will be re-
corded, sessions will be taped when patients are agreeable,
and tapes will be rated for fidelity and competence. Patient
beliefs about the potential effectiveness of the intervention
that he or she receives will be assessed after the first
session with the Credibility/Expectancy Questionnaire
[44], and therapeutic empathy will also be assessed
with a patient questionnaire [45].
In The Feeling Safe Programme, following an assess-
ment, the patient is offered a menu of appropriate treat-
ment modules. Typically three to four modules are
completed, based on patient preference. The range of
modules that can be offered are improving sleep, redu-
cing worry, increasing self-confidence, reducing the im-
pact of voices, improving reasoning processes, and
behavioural tests for reducing fear beliefs. Befriending,
called in the trial ‘Feeling Safe and Supported’ will follow
a protocol devised by one of the trial team members
(DK) that has previously been used in two large clinical
trials for patients with psychosis over 20 sessions [21, 22].
Essentially, the aim is to simulate how a good friend would
respond and involves a general focus on non-threatening
topics (although patients are not actively dissuaded from
talking about concerns), non-confrontation, empathy, and
supportiveness.
Statistical and economic analysis plan
A full statistical analysis plan will be written by the trial
statisticians (RE, GD) prior to any analysis being under-
taken. We will report data in line with the Consolidated
Standards of Reporting Trials (CONSORT) 2010 Statement
(http://www.consort-statement.org/consort-2010), showing
attrition rates and loss to follow-up. All analyses will be car-
ried out using the intention-to-treat principle with data
from all participants in the analysis, including those who do
not complete therapy. Every effort will be made to follow
up all participants in both arms for research assessments.
Freeman et al. Trials (2016) 17:134 Page 5 of 8
http://www.euroqol.org/
http://www.consort-statement.org/consort-2010
Analysis will be conducted in Stata version 14 [46].
Descriptive statistics within each randomised group will
be presented for baseline values. These will include
counts and percentages for binary and categorical vari-
ables and means and standard deviations, or medians
with lower and upper quartiles, for continuous variables,
along with minimum and maximum values and counts
of missing values. There will be no tests of statistical sig-
nificance or confidence intervals for differences between
randomised groups on any baseline variable.
Descriptive statistics will be used to summarize assess-
ments of feasibility and acceptability in terms of recruit-
ment, drop-out, and completeness of therapy.
The primary hypothesis for change in the primary out-
come measure, conviction in the persecutory delusion
(using a 0 to 100 % scale) at 6 months, will be analysed
using a linear regression model allowing for the base-
line measurement of outcome, severity of delusion,
therapist and treatment assignment as fixed effects. To
compare rates of recovery (scores falling below 50 %),
we will use logistic regression models instead of linear
models. Secondary outcome measures will be analysed
using the same modelling approach. This includes ana-
lysis of the primary outcome and secondary outcomes
at 12 months.
The mediation analysis will investigate putative medi-
ational factors using modern causal inference methods
[47, 48]. This involves using parametric regression
models to test for mediation of the Feeling Safe Inter-
vention on outcome through the putative mediators.
Analyses will adjust for baseline measures of the medi-
ator, outcomes, and possible measured confounders.
We will include repeated measurement of mediators
and outcomes to account for classical measurement
error and baseline confounding, and where feasible, use
instrumental variable methods (baseline covariate by
randomization interactions as potential instruments) to
investigate the sensitivity of the estimates to these
problems and that of unmeasured confounding.
Moderators will be assessed separately by repeating
the primary analysis models and including interaction
terms between the randomised intervention and each
moderator. The coefficient of the interaction term is a
measure of whether the treatment effect differs between
levels of the moderator.
Missing data on individual measures will be pro-
rated if more than 90 % of the items are completed;
otherwise the measure will be considered as missing.
We will check for differential predictors of missing
outcomes by comparing responders to non-responders
on key baseline variables. Any significant predictors
will be included in the analysis models. This accounts
for missing outcome data under a missing at random
assumption, conditional on the covariates included in
the model. As a sensitivity analysis, we will assess
whether treatment adherence is associated with miss-
ing data, and if it is associated, use inverse probability
weights or multiple imputation to compare results.
An economic evaluation will estimate the cost per
quality adjusted life year (QALY) gained from a health
and social care perspective over the 1-year timeframe of
the trial. An economic model will be used to explore the
potential cost effectiveness of the intervention over the
patient’s lifetime. A detailed analysis plan for the eco-
nomic evaluation will be prepared by the trial health
economist (LMD) prior to the analysis. This will be in-
formed by exploratory analyses of the pooled baseline
data and published literature.
For a recovery rate in delusions of 50 % in the Feeling
Safe Programme, compared to 20 % with befriending, a
study will have over 90 % power with 60 patients in
each arm. The trial will, however, gain greater power
by also examining change in delusion dimensional
scores. If the standardised effect of the new interven-
tion compared to befriending were smaller than 10
percentage points on the conviction scale (0 to 100 %)
(d = 0.5), then we would not consider further develop-
ment of the intervention to be worth pursuing. If the
true effect size were this ten-point difference (SD = 20),
then a two-sample t-test with a two-sided significance
level of 0.05 would have 80 % power to detect a statis-
tically significant effect with outcome data available for
64 participants per randomised arm. We aim to recruit
75 per arm. This conservatively allows for a drop-out
of 15 %. Allowing for stratum membership and base-
line levels of the measures in a more refined analysis
of covariance will increase both statistical power and
precision.
Discussion
Over the past 15 years, a significant advance has oc-
curred in the understanding of the causes of paranoia.
This research has predominately been from a cognitive
perspective [12,49–52]. The advance in knowledge is be-
ginning to be translated into treatment. From our theor-
etical model, the clinical goal becomes to enable the
patient to form a strong belief concerning current safety,
thereby allowing the persecutory threat belief to dissi-
pate. Hence the influence of the maintenance factors
needs to be reduced and patients re-enter the threatening
situations in order to learn directly that nothing adverse
occurs. Toleration of the high anxiety, associated physio-
logical arousal, and other anomalous experiences needs to
occur. This learning of safety should allow a fundamental
shift of attention away from activation of the negative
valence system. From this perspective, clinical trials need
to recruit patients on the presence of having persecutory
delusions, and such delusions and related behaviours
Freeman et al. Trials (2016) 17:134 Page 6 of 8
should become the main outcome. The Feeling Safe Study
will be such an example. Translating our cognitive model,
a series of studies of persistent persecutory delusions have
shown the benefits of targeting the maintenance factors
individually. The current trial aims to determine the
efficacy, above that of simple therapist effects, of a full
treatment based on the theoretical understanding. The
potential is a substantial improvement in treatment for
persistent persecutory delusions. Outcome results are
expected in 2020.
Trial status
The trial is due to start patient recruitment in February
2016.
Abbreviations
CBT: cognitive behavioural therapy; CHOICE: Choice of
Outcome In CBT for
Psychoses; CONSORT: Consolidated Standards of Reporting
Trials; CSRI: Client
Service Receipt Inventory; DAR-5: Dimensions of Anger
Reactions;
DMEC: Data Monitoring and Ethics Committee; EPQ: Economic
Patient
Questionnaire (EPQ); EQ-5D-3 L: EuroQual Five Dimensions
Three Levels;
LTCQ: Long Term Conditions Questionnaire; NHS: National
Health Service;
PAG: Patient Advisory Group; QALY: quality-adjusted life
year; SPEQ: Specific
Psychotic Experiences Questionnaire; TSC: Trial Steering
Committee..
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
DF conceived the study and is the chief investigator. All study
authors
contributed to the design of the trial. FW will coordinate the
study. DF will
supervise the psychological interventions. DK will advise on the
befriending
intervention. GD and RE will carry out the outcome,
moderation, and mediation
analyses. LD will carry out the health economic evaluation. RF
will lead on the
qualitative study. All authors read and approved the final
manuscript.
Acknowledgements
The trial is funded by an NIHR Research Professorship awarded
to DF. The
funder reviewed the design of the trial but did not make any
alterations or
have a role in writing or submitting this paper for publication.
This paper
presents independent research funded by the National Institute
for Health
Research (NIHR). The views expressed are those of the authors
and not
necessarily those of the NHS, the NIHR or the Department of
Health.
Author details
1Department of Psychiatry, University of Oxford, Warneford
Hospital, Oxford
OX3 7JX, UK. 2Centre for Biostatistics, Institute of Population
Health,
Manchester University, Manchester Academic Health Centre,
Manchester, UK.
3Academic Department of Psychiatry, Faculty of Medicine,
University of
Southampton, Southampton, UK. 4Centre for Health Economics,
Institute of
Population Health, Manchester University, Manchester
Academic Health
Centre, Manchester, UK. 5Nuffield Department of Population
Health,
University of Oxford, Oxford, UK.
Received: 30 January 2016 Accepted: 19 February 2016
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http://dx.doi.org/10.3310/hta19930
https://www.researchgate.net/publication/297893567AbstractBa
ckgroundMethods/designDiscussionTrial
registrationBackgroundThe translational studies leading to the
trialThe new clinical
trialMethodsDesignParticipantsRandomisation and
blindingAssessmentsAdverse eventsPsychological
interventionsStatistical and economic analysis
planDiscussionTrial statusAbbreviationsCompeting
interestsAuthors’ contributionsAcknowledgementsAuthor
detailsReferences
Schizophrenia Research 165 (2015) 243–246
Contents lists available at ScienceDirect
Schizophrenia Research
journal homepage: www.elsevier.com/locate/schres
Jumping to conclusions and the persistence of delusional beliefs
in first
episode psychosis
M. Aurora Falcone a,b,⁎, Robin M. Murray b, Jennifer A.
O'Connor b, Leanne N. Hockey b, Poonam Gardner-Sood b,
Marta Di Forti b, Daniel Freeman c, Suzanne Jolley a
a King's College, London, Department of Psychology, Institute
of Psychiatry, Psychology & Neuroscience, London, UK
b King's College, London, Department of Psychosis Studies,
Institute of Psychiatry, Psychology & Neuroscience, London,
UK
c University of Oxford, Department of Psychiatry, Warneford
Hospital, Oxford, UK
⁎ Corresponding author at: Department of Psychos
Psychiatry, Psychology & Neuroscience, De Crespigny
Tel.: +44 207 848 0100; fax: +44 207848 0287.
E-mail address: [email protected] (M.A. Falcon
http://dx.doi.org/10.1016/j.schres.2015.04.019
0920-9964/© 2015 Elsevier B.V. All rights reserved.
a b s t r a c t
a r t i c l e i n f o
Article history:
Received 29 November 2014
Received in revised form 28 February 2015
Accepted 15 April 2015
Available online 6 May 2015
Keywords:
Psychosis
Delusions
Reasoning
Jumping to conclusions
Neuropsychology
Background: Cognitive biases may contribute to delusion
persistence. We tested this in a longitudinal study of
first episode psychosis (FEP).
Methods: 34 FEP patients completed assessments of delusions
and Jumping to Conclusions (JTC) at baseline and
12-month follow-up.
Results: JTC was associated with baseline delusion severity
(t(32) = 2.7, p = 0.01). Baseline delusions persisted at
follow-up for 8/20 participants (40%), who all jumped to
conclusions (8/8, 100%), compared to half of those with
no or changeable delusions (14/26, 54%; χ2 (df = 1) = 5.7, p =
0.03; Phi = 0.4).
Conclusion: Findings implicate cognitive biases in delusion
persistence, and support the potential to reduce delu-
sions through reasoning-focused interventions.
© 2015 Elsevier B.V. All rights reserved.
1. Introduction
The Jumping to Conclusions (JTC) bias is a tendency to make
decisions
with certainty based on limited data-gathering. There is
substantial
support for its presence in patients with delusions (Fine et al.,
2007;
Garety et al., 2011; So et al., 2012; Garety and Freeman, 2013;
Jolley
et al., 2014), and emerging evidence of associations with
outcome and
change in delusions, both as a potential marker for response to
antipsy-
chotic medication (Andreou et al., 2014; Menon et al., 2008; So
et al.,
2014) and a manipulable target of psychological intervention
(e.g.
Garety et al., 2014; Lincoln et al., 2014; Moritz et al., 2013;
Sanford
et al., 2013; Warman et al., 2013).
To date, only one study has investigated JTC and delusion
persistence
in first episode psychosis (FEP; Dudley et al., 2013). Dudley
and col-
leagues found persistent JTC and delusions to be associated at
follow-
up, but no baseline associations, providing only partial support
for a
maintaining role of JTC. Possible reasons for the failure to find
baseline
associations include subjective rating of delusions according to
the di-
mension of distress and low baseline rates of JTC and delusion
severity.
Our own previous work showed that, when using objective
assessments
is Studies, PO 52, Institute of
Park, London SE5 8AF, UK.
e).
of delusions, in a FEP group with rates of delusions and JTC
comparable
to those found in established psychosis, the baseline association
of the
JTC bias with delusion severity was replicated (Falcone et al.,
2014).
The current study is a longitudinal follow-up of the same
participants
at 12-months. Our aim was to investigate the association of the
JTC bias
with delusion persistence, as persistent delusions are the targets
of
psychological intervention. We hypothesised firstly that we
would
replicate the association of JTC with delusion severity at
baseline
(i.e. during a psychotic episode) found in our larger sample, and
secondly
that the persistence of delusions at a clinical level of severity
would be
associated with the tendency to JTC.
2. Methods
2.1. Participants
Thirty-four participants (31% of the baseline sample (n = 108)
re-
ported by Falcone et al., 2014) completed measures of delusions
and
reasoning at both baseline and 12-month follow-up. All
participants
completing study measures at the two time points were
included. Par-
ticipants were assessed as part of the Genetics and Psychosis
(GAP)
study (Di Forti et al., 2012; O'Connor et al., 2012; Stilo et al.,
2013;
Wiffen et al., 2014) which was designed to identify genetic and
environ-
mental factors associated with psychosis. Ethical approval was
granted
by the joint Institute of Psychiatry and South London and
Maudsley
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Table 1
Demographic and clinical characteristics at baseline and follow-
up.
Baseline
(n = 34)
Follow-up
(n = 34)
p
Mean (SD)
Age in years 27.9 (7.9) 29.1 (7.7)
[Range] [18–50] [19–51]
PANSS delusion severity 2.7 (1.4) 2.2 (1.6) t = 1.8 (df = 33),
p = 0.08
[Range] [1–6] [1–6]
n (%)
JTC
85:15 14 (41) 13 (38)
60:40 9 (26) 10 (29)
Either 15 (44) 14 (41) p = 1.0a
244 M.A. Falcone et al. / Schizophrenia Research 165 (2015)
243–246
NHS Foundation Trust Research Ethics Committee; all
participants
gave informed written consent. GAP clinical inclusion criteria
were:
a current diagnosis of first episode psychosis (determined by
clinical
interview according to OPCRIT and DSM-IV criteria (APA,
1994;
McGuffin et al., 1991)); within six months of first contact with
services;
current psychotic symptoms, experienced for at least seven
days; age
18–65 years. Exclusion criteria were: a history of moderate or
severe
learning disabilities, or current IQ b 70, as assessed by the
Wechsler
Adult Intelligence Scale—Third Edition (Wechsler, 1997);
insufficient
command of English to complete assessments; a history of
previous
contact with mental health services for psychosis; a primary
diagnosis
of alcohol or substance dependency or a known organic cause of
psychosis.
Delusion presence 20 (59%) 13 (38%) p = 0.03a
Diagnosis
Schizophrenia 8 (23)
Schizophreniform disorder 5 (15)
Psychotic disorder NOS 6 (18)
Schizoaffective disorder 4 (12)
Affective disorder with psychosis 11 (32)
Key: PANSS, Positive and Negative Syndrome Scale; JTC,
Jumping to Conclusions.
a McNemar test; NOS: not otherwise specified.
2.2. Measures
Demographic data were collected by self-report, supplemented
by clinical records. The delusion item of the Positive and
Negative
Syndrome Scale (PANSS; Kay et al., 1987) provided ratings of
mean
delusion severity (from 1 (absent) to 7 (extremely severe)).
Delusion
presence (rating ≥3 (mild)) was dichotomised into persistent
(present
at baseline and 12-month follow-up) or not (absent/present only
once).
Jumping to Conclusions (JTC): Two versions of the
Probabilistic Rea-
soning ‘Beads’ Task (Garety et al., 2005) were employed, with
beads in
85:15 and 60:40 ratios. Participants were shown two jars
containing
coloured beads in opposite ratios (e.g., mainly black: 85 black
and 15
orange beads; mainly orange: 85 orange and 15 black beads),
then a
series of beads, one at a time, drawn from one of the two jars
randomly
selected by the computer. Participants were asked to request as
many
beads as they needed to be certain of the jar of origin. Deciding
after
fewer than three beads was classified as JTC. As we were
concerned
with the potential for the bias to influence day-to-day decision-
making, rather than its consistency between tasks, or over time,
we con-
sidered a single hasty decision on any task, at any time point to
be evi-
dence of the tendency to JTC, and rated this dichotomously (no
JTC/JTC
at least once; Garety et al., 2005; Jolley et al., 2014; So et al.,
2012).
2.3. Analyses
Data were analysed using the Statistical Package for the Social
Sciences Version 20.0 (IBM, 2011). Rates of JTC and delusions
and delu-
sion severity were compared at baseline and follow-up using
McNemar
tests and paired sample t-tests. For hypothesis one, severity of
delusions
between JTC groups at baseline was compared using
independent sample
t-tests. For hypothesis two, rates of JTC between those with and
without
persistent delusions were compared using Chi-square tests.
3. Results
Demographic and clinical characteristics are shown in Table 1.
Participants were predominantly male (22/34, 65%) and of
Black or
Minority Ethnic (BME) background (23/34, 68%).
3.1. Hypothesis 1: JTC will be associated with the severity of
delusions
at baseline
The findings replicated our previous report (Falcone et al.,
2014),
with more severe delusions in those showing the JTC bias (JTC
mean:
3.4 (SD 1.4); no JTC mean: 2.2 (SD 1.2), t = 2.7, df = 32, p =
0.01).
Of the 20 participants with delusions at baseline, 55% (11/20)
jumped to conclusions, compared to 29% of those without
delusions
(4/14).
3.2. Hypothesis 2: JTC will be associated with the persistence
of delusions at
follow-up
Overall rates of JTC remained consistent, with two thirds
showing
the bias at least once (22/34; 65%), though only seven
individuals
showed the bias consistently (Table 2). Rates of delusions
reduced,
with a non-significant reduction in delusion severity (Table 1).
Nearly
half of those with delusions at baseline had persisting delusions
at
follow-up (8/20; 40%), and all those with persisting delusions
jumped to conclusions at least once (8/8, 100%), compared to
half
of those with no (6/11) or changeable (8/15) delusions (14/26,
54%; χ2 (df = 1) = 5.7, p = 0.03; Phi = 0.4; Table 2).
4. Discussion
We tested associations of the JTC reasoning bias with delusion
per-
sistence in FEP. The prevalence and severity of delusions and
rates of
JTC in followed-up participants matched our previous, larger
study
(Falcone et al., 2014), suggesting that this subsample comprised
repre-
sentative participants. At baseline, during participants' first
psychotic
episode, the well-established association of delusion severity
with JTC
was replicated. Over time, rates of JTC remained stable, but
individual
participants showed variation in their data-gathering, with only
a
third never jumping to conclusions. Delusions mostly improved
over
time, but persisted for around half of participants. All
participants with
persisting delusions jumped to conclusions at least once,
compared to
only half of those with no or changeable delusions. The
association of
JTC with delusion persistence was significant, with a medium to
large
effect size. Limitations of the study include the small number of
partic-
ipants followed up from baseline (31%); that we did not control
for
the effects of medication or any other treatments; and that data
on
age of onset were not collected for this study. The mean
delusion scores
presented in Table 2 are based on small numbers, and are
reported to
explicate the results, rather than to represent a reliable
statistical average.
We operationalised JTC as a dichotomous variable, using the
criterion of
fewer than three beads to indicate the presence of the bias.
Analyses of
the number of draws to decision, or employing an alternative
dichotomy,
were not carried out, and may have given different results.
Finally,
notwithstanding the longitudinal design of the study, we did not
test
whether the bias precedes the development of delusions, and a
causal
role for the bias in the onset of delusions cannot be inferred
from these
results.
Table 2
Number of participants showing each pattern of change in
Jumping to Conclusions (JTC) and delusions over time, with
mean delusiona severity scores (SD) at baseline (BL) and
follow-up (FU).
Delusion-free at least once Persistent
Delusions
Total
No delusions
at BL or FU
Delusions at BL only Delusions at FU only
No JTC BL 1.2 (0.4) 3.5 (0.5) 1.0 (–) – 2.3 (1.3)
FU 1.2 (0.4) 1.5 (0.5) 6.0 (–) – 1.75 (1.4)
n 5/11 6/12 1/3 0/8 12/34
JTC at least once BL 1.3 (0.5) 3.5 (0.8) 2.0 (0) 4.0 (1.2) 3.0
(1.4)
FU 1.0 (0) 1.0 (0) 3.5 (0.7) 4.3 (0.9) 2.4 (1.7)
n 6/11 6/12 2/3 8/8 22/34
- JTC at BL only BL 2.0 (–) 3.3 (0.6) – 4.5 (1.3) 3.8 (1.3)
FU 1.0 (–) 1.0 (0) – 4.7 (1.0) 2.9 (2.1)
n 1 3 0 4 8
- JTC at FU only BL 1.3 (0.5) 3.0 (–) – 3.0 (0) 2.0 (1.0)
FU 1.0 (0) 1.0 (–) – 4.0 (0) 1.9 (1.5)
n 4 1 0 2 7
- JTC at BL & FU BL 1.0 (–) 4.0 (1.4) 2.0 (0) 4.0 (1.4) 3.0 (1.5)
FU 1.0 (–) 1.0 (0) 3.5 (0.7) 3.5 (0.7) 2.4 (1.4)
n 1 2 2 2 7
Total BL 1.3 (0.5) 3.5 (0.7) 1.7 (0.6) 4.0 (1.2) 2.7 (1.4)
FU 1.1 (0.3) 1.3 (1.4) 4.3 (1.5) 4.3 (0.9) 2.2 (1.6)
n 11 12 3 8 34
Key: JTC, Jumping to Conclusions; BL, baseline; FU, follow-
up.
a Measured by the PANSS (Kay et al., 1987).
245M.A. Falcone et al. / Schizophrenia Research 165 (2015)
243–246
Our findings do support a maintaining role for the JTC bias in
delusions. They also support the growing evidence base
showing
the effectiveness of targeted interventions to modify JTC, such
as
the Maudsley Review Training Programme (Waller et al., 2011),
Metacognitive Training (MCT; Moritz et al., 2014a, 2014b) and
Social
Cognition and Interaction Training (SCIT; e.g. Roberts et al.,
2014), in
reducing delusion persistence and improving outcomes for
people
with psychosis.
We thank the study participants for their time, and the GAP
team.
This work was supported by the NIHR Biomedical Research
Centre
for Mental Health at the South London and Maudsley NHS
Foundation
Trust and Institute of Psychiatry, Psychology & Neuroscience,
King's
College London; the Institute of Psychiatry, Psychology &
Neuroscience
at King's College London; and the Psychiatry Research Trust.
DF is sup-
ported by a Medical Research Council Senior Clinical
Fellowship.
Role of the funding source
This work was supported by the NIHR Biomedical Research
Centre for Mental Health
at the South London and Maudsley NHS Foundation Trust and
Institute of Psychiatry, Psy-
chology & Neuroscience, King's College London; the Institute
of Psychiatry, Psychology &
Neuroscience at King's College London; and the Psychiatry
Research Trust. DF is supported
by a Medical Research Council Senior Clinical Fellowship
(G0902308).
Acknowledgement
We thank the study participants for their time, and the GAP
team.
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http://refhub.elsevier.com/S0920-9964(15)00210-
8/rf0135Jumping to conclusions and the persistence of
delusional beliefs in first episode psychosis1. Introduction2.
Methods2.1. Participants2.2. Measures2.3. Analyses3.
Results3.1. Hypothesis 1: JTC will be associated with the
severity of delusions at baseline3.2. Hypothesis 2: JTC will be
associated with the persistence of delusions at follow-up4.
DiscussionRole of the funding
sourceAcknowledgementReferences
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reproduction prohibited without permission.
Psychiatric Disorders Characterized by Delusions: Treatment in
Relation to Specific Types
Munro, Alistair, MD, FRCPC
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Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further
reproduction prohibited without permission.
Pergamon
Behav. Res. Ther. Vol. 32, No. 3, 355-367, 1994 pp.
Copyright 0 1994 Elsevier Science Ltd
00057967(93)EOO12-T
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A COGNITIVE APPROACH TO MEASURING AND
MODIFYING DELUSIONS
P. D. J. CHADWICK’* and C. F. LOWE*
‘School of Psychology, University of Birmingham, Edgbaston,
Birmingham B15 2TT, U.K
2University College of North Wales, University of Wales,
Bangor, U.K.
(Received 11 May 1993)
Summary-The present paper summarizes and integrates with the
existing literature the results of three
studies we have conducted on the measurement and
modification of delusions. The findings of two of these
studies have been presented previously; the third is briefly
reported here. A total of 12 people with
delusions took part. Ten participated in two investigations that
used between-subject multiple-baseline
designs; the remaining two, each of whom held three distinct
delusions, took part in a study using an
across-beliefs multiple-baseline design. A variety of dimensions
of delusional experience were monitored
over baseline periods of at least 4 weeks, and two distinct
cognitive interventions were used: a structured
verbal challenge and a planned empirical test. Our focus in the
present article is on intervention and the
process of change as people come to question and sometimes
reject their delusions. We also address related
issues, including problems of measurement (i.e. demand
characteristics, independent validation), the
connection between depression and delusions and the prediction
of treatment response. We conclude with
specific recommendations for cognitive therapy for delusions.
THE COGNITIVE PERSPECTIVE ON DELUSIONS
Our theoretical perspective on delusions has been influenced by
two main sources, the literature
on verbal self-regulation of behaviour (Lowe, 1979; Lowe,
Horne & Higson, 1987) and Maher’s
(1974, 1988) work on delusions. Our interest has been on the
common features of delusional
thinking. Thus, our experimental strategy has been directed at a
variety of delusion types (paranoid,
grandiose, control and identity). Maher (1974, 1988) proposed
that a delusion can be regarded as
a normal attempt to make sense of an abnormal perceptual
experience. A clear paradigm case
would be a delusion that was secondary to auditory
hallucinations, the argument here being that
the hallucinations puzzled and perhaps distressed the individual
concerned, and so he or she
searches for a meaningful explanation of them. The delusion
would arise from this effort after
meaning, and would be invested with the psychological force of
having rid the individual of the
sense of bewilderment. According to Maher, the reasoning
processing that produces delusions does
not differ from that which produces so-called ‘normal’ beliefs;
it is just that bizarre perceptions
demand bizarre explanations.
Maher’s contention that a delusion may be rational, although
incorrect, has been questioned
recently with the discovery that people with delusions have
biased reasoning (see Bentall,
Kinderman & Kaney, 1994, this issue pp. 331-341). Under
certain experimental conditions people
with delusions appear to show bias in their attributional style,
in their judgement of covariance,
and in their probabilistic reasoning (Garety, 1991). However,
this raises a number of consider-
ations. First, it is sometimes difficult to interpret such findings
vis-ci-vis rationality. For example,
Huq, Garety and Hemsley (1988) using a neutral task which
required subjects (Ss) to make
inferences about the likely ratio of different coloured beads in a
jar, investigated the probabilistic
reasoning of a group of deluded people, a group of mixed
psychiatric patients who were not deluded
and a group of matched controls. People with delusions were
found to require the least beads to
be drawn from the jars before forming their conclusions and
also to express most confidence in
their decisions, and yet this ‘jumping to conclusions’ was nearer
optimum reasoning than the
caution displayed by other Ss. Also, it is not always clear how
specific findings in analogue studies
might apply to delusional thinking. For example, how might it
be established if delusions are
*Author for correspondence.
355
356 P. D. J. CHADWICK and C. F. LOWE
formed on the basis of less information than, say, religious
beliefs or depressive beliefs? Second,
the evidence is for bias, not deficit; it might reasonably be
inferred that the observed bias is a
consequence of delusional behaviour, rather than the delusion
being a consequence of the bias.
TO distinguish between rational and irrational thinking is not
straightforward, Indeed, it may
be that debate about the rationality of delusions runs the risk of
obscuring the main value in
Maher’s theory-i.e. that in delusions the primary underlying
motivation is attributional, and
that they may be thought of as an attempt to make sense of
particular events. (It has been an
integral part of our approach to challenging delusions that the
person be encouraged to construe
his or her delusion as a reaction to, and an attempt to make
sense of, particular events, and that
an alternative perspective from which to understand these
events be supplied and evaluated.)
Viewing delusions in this way has some interesting
implications. One is that although delusions
may not be culturally shared, they are grounded in external
events. In an important sense the
person, not a hidden pathology, constructs the belief. A related
implication, which is born out in
our research, is that people can presumably describe some, or
perhaps all, the experience
(‘evidence’), their delusions were invoked to explain, and their
accounts might shed light on the
process of delusion formation.
Maher’s perspective agrees well with the writing of Vygotsky
(1962) and Luria (1961) who
charted the developmental process by which language gradually
acquires a regulatory function
and comes to organize and drive behaviour. The regulatory
function of language is surprisingly
potent. For example, simply giving objects a label appears to
allow young children to use them
in a way that was not possible before, and also helps to abstract
the principle that guided this
organization and apply it elsewhere (Luria, 1961). Delusions,
like other beliefs, alter our relation
to the environment, because they organize and structure future
experience. It is important to
recognize that a beliefs regulatory potency does not hinge on its
accuracy, nor on the degree to
which it is the result of reason, nor on its adaptive value.
Several studies of human learning have
shown that the rules people form about contingencies of
reinforcement are often not based on
correct inference and do not produce optimum responding, yet
they exercise a unique control
over behaviour and are extremely resistant to change (Lowe,
1979, 1983; Horne & Lowe, 1993).
According to this account, there are important respects in which
delusions are like other beliefs.
This new emphasis on continuity, rather than discontinuity, is
nowhere more evident than in the
literature on defining and measuring delusions.
Traditionally, delusions have been defined on the basis of
empirical claims of discontinuity-
e.g. as beliefs that were undeniably false, that were held with
total and unshakable conviction,
that were not shared by others with the same cultural
background and that were based on
incorrect inference (DSM-III-R; APA, 1987). Individually these
criteria have been disputed: thus,
a delusion need not be false (Brockington, 1991), it need not be
held with absolute or unshakable
conviction (Brett-Jones, Garety & Hemsley, 1987; Watts,
Powell & Austin, 1973) and it need not
be based on incorrect inference (Garety, 1991). The criterion
relating to the unusual content of
delusions also may be questioned, since research has
demonstrated how difficult it is to rate the
‘bizarreness’ of delusions (Kendler, Glazer & Morgenstern,
1983). Traditional criteria have also
been challenged by a radical and exciting call to define
delusions as points on a continuum with
normality, the position on this continuum being influenced by
dimensions of delusional experi-
ence such as degree of belief conviction and the extent of
preoccupation with the belief (Strauss,
1969).
As well as stressing continuity, this new perspective also places
great emphasis on the individual
and on individual differences. For this reason, in our three
studies we used multiple-baseline
methodology (Kazdin, 1982) with its combination of
experimental control together with the
power to reveal individual diversity. Before, during, and after
therapy, we measured the degree of
conviction with which the delusion was held, the degree of
preoccupation with the delusion, the
concurrent degree of anxiety and the extent to which the person
observed confirmations and
disconfirmations. We also gave the Beck Depression Inventory
(BDI; Beck, Rush, Shaw &
Emery, 1979) during baseline, intervention, and follow-up to
assess for unwanted effects of the loss
or weakening of a delusion. One of the most striking aspects of
our findings on the modification
of delusions was the very individual nature of the process and
outcome of change, and for this
reason we strongly favour the use of sophisticated single-
subject methodology in this field.
Cognitive approach to delusions 357
ARE DELUSIONS OPEN TO MODIFICATION?
On occasion, psychiatric opinion appears to be absolutistic and
very difficult to change. For
example, it is often asserted that delusions cannot be modified
or are utterly insensitive to reason
(see Garety, 1985) and yet there are empirical grounds for
rejecting this opinion. There has been
a modest number of studies, including our own, reporting
attempts to weaken delusions, with
generally favourable results (Alford, 1986; Beck, 1952; Fowler
& Morley, 1989; Hartman &
Cashman, 1983; Hole, Rush & Beck, 1973; Johnson, Ross &
Mastria, 1977; Milton, Patwa &
Hafner, 1978). Whilst it is important to admit some
methodological shortcomings, and the need
to develop better measures and therapies, it seems unwise to
deny a priori these findings and their
implications.
It might be more reasonable to assert that delusions are difficult
to modify, sometimes fiendishly
so. This position would acknowledge that the class of beliefs
called delusions varies considerably
along a number of dimensions, and it would encourage
examination of the multitude of factors
which might be thought to influence therapeutic outcome. It
would also encourage an exploration
of whether delusions associated with a diagnosis of
schizophrenia are more difficult to modify than
political or religious beliefs, or the core beliefs associated with
conditions such as depression and
anorexia.
It is, of course, as fallacious to accept research uncritically as
to reject it out of hand. Research
on modifying delusions is in its infancy, and there are
methodological and conceptual problems
that render many of the findings suggestive rather than
definitive. We are nevertheless optimistic
that psychological therapy has a role to play, as we hope our
findings will demonstrate, but we
recognize the need for caution and for critical appraisal of
current theories and methods.
COGNITIVE THERAPY FOR DELUSIONS: AN
EXPERIMENTAL ANALYSIS
We carried out three studies on the use of cognitive therapy
(CT) to weaken delusional thinking
in people with a diagnosis of schizophrenia. In total, 12
outpatients took part, 8 men and 4 women,
all of whom were on stable neuroleptic medication. They ranged
in age from 28 to 63 years (average
36). All described clear delusions, which had been voiced at
varying points over at least the
preceding 2 years, though usually far longer. However, it should
be noted that though delusions
may be mentioned over a number of years, this is not
necessarily an accurate guide as to how long
they have been held (Strauss, 1991).
CT usually pursues cognitive change through a combination of
verbal challenge and planned
reality testing (Beck et al., 1979). In our research on delusions
we used each of these strategies in
separate interventions, and manipulated the order in which they
were introduced in an attempt to
understand more about how each works. Both interventions
were applied within an atmosphere
of ‘collaborative empiricism’ (Beck et al., 1979). Rather than
being told that they were wrong,
individuals were encouraged to see their delusions as being only
one possible interpretation of
events and they were asked to consider and evaluate an
alternative view. Also, because of our
dissatisfaction with current definitions of schizophrenia and
delusion, in speaking to the individuals
we did not use these labels to describe their experience.
The verbal challenge comprised four elements. To minimize the
likelihood of psychological
reactance (Brehm, 1962) the evidence for the beliefs was
challenged first; the order in which each
piece of evidence was challenged was inversely related to its
importance to the delusion (see Watts
et al., 1973). An integral part of this discussion involved the
therapist making clear to individuals
how strongly held beliefs can exert a profound influence over
their behaviour and interpretation
of events. Second, the internal consistency and plausibility of
the belief system was questioned, and
all irrational or inconsistent features were highlighted. Third,
following Maher, an alternative
perspective was offered, namely, that the belief was formed in
response to, and as a way of making
sense of, a specific experience-often this included a primary
symptom, but in several cases it was
hypothesized that the delusion was in part a response to
important life events. For example, a link
was drawn and discussed between patient DR’s belief that he
could communicate with people from
the past, and thereby prevent accidents and disasters, and the
accidental death of his father shortly
358 P. D. J. CHADWICK and C. F. LOWE
before the onset of symptoms. Lastly, the individual’s delusion
and the therapist’s alternative were
assessed in light of the available information.
The main feature of our reality testing intervention was that it
involved the individual planning
and performing an activity that could invalidate the delusion, or
some part of it (Hole et al., 1973).
Beck et al. (1979) called such activities behavioural
experiments, conveying that they were
performed in order to test a hypothesis. Strategically, the
primary purpose of both empirical testing
and verbal challenge is to bring about cognitive change,
although empirical testing is thought to
be the more powerful intervention. As Beck put it:
“There is no easy way to ‘talk the patient out’ of his
conclusions that he is weak, inept, or vacuous By helping the
patient change certain behaviours, the therapist may
demonstrate to the patient that his negative, overgeneralized
conclusions were incorrect.” (Beck el al., 1979, p. 118. original
emphasis.)
The effects of the interventions on three outcome measures
(conviction, preoccupation and
Conviction
Preoccupation
Anxietv
TD
100 5
4
100
50
0
100
50
s
5 0 ._
‘,
‘5 100
g
V
50
0
EE
50 3
2
1
0 0
Baseline Verbal Reality Follow-up
challenge tesring
Fig. 1. Bar graph summarizing 6 individuals’ (HM, TD, WH,
EE, MM & DR) weekly conviction,
preoccupation and anxiety scores during baseline, verbal
challenge, reality testing and follow-up.
Cognitive approach to delusions
HI
IC onviction
359
100 5
4
3
50
2
1
0 0
x
100 5 z ._
4 2
3 ‘c)
g 50 2 5
C
z 1 .8
‘- 6 0 0 ; ._
2 100 5 ::
6
4
s
EL
50
3
2 z
5
1 ::
0 Ozz
100 5
4
3
50
2
1
” 0
Baselille Reality Verbal Follow-up
testing challenge
Fig. 2. Bar graph summarizing 4 individuals’ (HJ. LJ, CE & FD)
weekly conviction, preoccupation and
anxiety scores during baseline, reality testing. verbal challenge
and follow-up.
anxiety) are shown in Figs 1-3. Figure 1 summarizes data from
6 individuals who received the
verbal challenge first, 3 of whom went on to receive the reality
testing second [for detailed sessional
results see Chadwick and Lowe (1990)]. Figure 2 summarizes
data for a further 4 individuals who
all received the reality testing first and the verbal challenge
second [see Chadwick and Lowe (in
press) for details]. The two studies reported in Figs 1 and 2
used multiple-baseline designs across
individuals. Figure 3 summarizes two single case studies, in
both of which the verbal challenge was
used in a multiple-baseline across delusions design to challenge
three delusions; the three delusions
were challenged successively at intervals of 4 or more weeks in
the sequence of ordering used in
Fig. 3 [for a full account, see Lowe and Chadwick (1990)].
Briefly, the delusions were as follows:
BP believed that a woman, Amanda, was reading his mind and
controlling his life, and that in past
lives he had been Leonardo da Vinci and Jesus Christ; BG who
was 51 years old, believed that
she was only a teenager, that she was the daughter of Princess
Anne, and that the Government
was controlling her in elaborate and fantastic ways.
Conviction
Of the 12 participants, 10 (83%) reported reductions in their
level of belief conviction as a
consequence of the interventions, and 5 had rejected their
delusions altogether by the close of the
intervention period. In 10 cases conviction remained stable over
baseline periods of between 4 and
10 weeks. Two individuals maintained their baseline levels of
conviction throughout the interven-
tion phases. For all individuals these changes were corroborated
during assessment interviews with
independent clinicians, and in 5 cases there was additional
authentication from either a second
professional or relative.
The verbal challenge was a strong opening intervention. In the
study depicted in Fig. 1, verbal
challenge periods of &6 weeks provoked stable and large
reductions in three (HM, TD & DR)
of the 6 individuals and a substantial but transient reduction in
a further person (EE). In spite of
360 P. D. J. CHADWICK and C. F. LOWE
this, when reality testing followed the verbal challenge, in 2 out
of 3 cases (EE & MM) it improved
upon the effectiveness of the verbal challenge alone, suggesting
that reality testing is a strong
intervention when it follows the verbal challenge. Both
individuals shown in Fig. 3 had rejected
their three delusions by the close of the 14 sessions of verbal
challenge. However, it should be noted
that in the case of BP, an apparent generalization effect meant
that conviction in the Leonardo
belief had already fallen to only 10% by the time it was
challenged.
When reality testing was used as a first intervention over 224
weeks with 4 people (Fig. 2) only
LJ showed a substantial drop in conviction, and this effect was
transient with conviction returning
to baseline level by the close of the reality testing period; her
conviction fell again at the start of
the verbal challenge period and this reduction was maintained.
For the remaining 3 individuals,
reality testing had little or no effect, although 2 (HJ & EE)
showed a large fall in conviction during
the subsequent verbal challenge period. For CE the verbal
challenge, like reality testing, failed to
alter conviction.
Verbal
challenge
Follow-up y
Fig. 3. Bar graph summarizing 2 individuals’ (BP & BG) weekly
conviction, preoccupation and anxiety
scores for each of their three delusions during baseline, verbal
challenge and follow-up.
Cognitive approach to delusions 361
Table I. BDI scores for all 12 participants at the final baseline
session, the final intervention
session and at the I-, 3-, and 6-month follow-ups (FU)
Individual Baseline Intervention I-Month FU 3-Month FU 6-
Month FU
HM
TD
WH
EE
MM
DR
HJ
LJ
CE
FD
BP
BG
I9
35
I8
24
20
23
28
9
2s
I3
I7
I4
27
17
20
0
I9
I2
24
9
22
5
6
I7
27
8
6
0
17
IO
18
IO
20 ^
5
5
5
0
IO
IO
I6
I2
20
6
II
3
27
7
5
0
4
8
IO
8
9
24
8
On the basis of these results, reality testing on its own would
seem to be a weak intervention,
perhaps because strongly held beliefs are ‘immunized’ against
disconfirming events (Popper, 1977).
This finding gives preliminary empirical support to a hitherto
untested assumption about CT,
namely, that empirical testing is more effective when it follows
a period of verbal challenge (e.g.
Trower, Casey & Dryden, 1988).
Preoccupation and anxiety
At the close of every session we used personal questionnaire
methods to extract a retrospective
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1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx
1.Freeman, S. (2011). Improving cognitive treatments for delus.docx

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1.Freeman, S. (2011). Improving cognitive treatments for delus.docx

  • 1. 1. Freeman, S. (2011). Improving cognitive treatments for delusions. Schizophrenia Research, 132, (2–3), 135-139. doi:10.1016/j.schres.2011.08.012 generation CBT for psychosis was successful but the strength of the treatment was weak and as the author states similar to those of clozapine (an antipsychotic used as a last resort for psychosis). Therapy is not up to date as it should be for delusions as delusion are understood quite well and therapy needs to catch up. The treatment of CBT for psychosis is similar to CBT treatment for anxiety. Pay attention to single symptoms in psychosis 2. Munro, Alistair (May 1992) Psychiatric Disorders Characterized by Delusions: Treatment in Relation to Specific Types. Psychiatric Annals, 22, 5, ProQuest Central pg. 232 3. Ho-wai So, S., Roisin Peters, E., Swendsen, J., Garety, P.A., & Kapur, S. (2014) Changes in delusions in the early phase of antipsychotic treatment – An experience sampling study. Psychiatry Research 215, 568-573 Summarize including the research question addressed in the source, if applicable, and major findings. Evaluate the usefulness of the source for your literature review, making sure to directly state why the source is informative for
  • 2. your specific topic Three dimensions of delusions are always present in factor analyses and they are a conviction, distress, preoccupation, and disruption to life. More studies need to be done to learn how delusions respond to antipsychotic. Conviction has been least amenable to change shows the studies. Many studies ponder the question, “why does conviction exist?” There have been studies that show that reasoning bias including “Jumping to conclusion (JTC)” bias and by patients being inflexible contributes to the maintenance of delusions. JTC has also shown that the dimension of conviction of delusions and the severity of delusions is influenced by JTC. Delusions improve during the first few weeks of treatment and some studies show improvement in the first few hours. It was hypothesized that delusion distress and preoccupation would reduce significantly over two weeks of antipsychotic treatment; but not a conviction. Female participants showed a higher response on all four delusion dimensions compared to the male participants. 57% of the participants showed the JTC bias. The no-JTC group showed a larger improvement in conviction and distress and with their delusions in general. This study is important for my literature review and further studies because the three dimensions of delusions: distress, preoccupation, and conviction are important for the clinical implications of treatment. If we take into account these three dimensions it will benefit further research and treatments. 4. The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomized controlled trial (The Feeling Safe Study) Freeman et al. (2016) Trials, 17:134. doi:10.1186/s13063-016- 1245-0
  • 3. Summarize including the research question addressed in the source, if applicable, and major findings. Evaluate the usefulness of the source for your literature review, making sure to directly state why the source is informative for your specific topic This study looks at how individuals with persecutory delusions, unfounded beliefs, believe that others are trying to harm them. We know that treatments for persecutory delusions need to be improved. The first-line treatment is usually medication and this has drawbacks as well: side effects, non-compliance, residual symptoms. The author shows that the maintenance of persecutory delusions has 6 components that we need to take into account while treating delusions and they are: worry, negative self-beliefs, unusual experiences, sleep dysfunction, reasoning bias and safety behaviors. Treatment needs to target these maintenance factors. The strongest test so far in the literature has been in reducing worry where “The Worry Intervention Trial” which took place with 150 patients and had a 95% follow-up rate. At a 6 month follow up it showed that 2/3 of the reduction in the delusions that patients experienced were due to a decrease in worry. Also increases in psychological well-being and psychiatric symptoms. There was also a pilot study that took place before the study that the authors did and this study (The Self-Confidence Study) looked at 30 patients who had persecutory delusions and increased positive self- beliefs by using techniques to decrease negative self-beliefs. The treatment had an effect size of 1.0 for positive self-beliefs and 1.2 for psychological well-being, reductions in negative self-beliefs 0.24 and the delusions 0.6. Other studies have looked at 31 patients with persistent delusions and used the treatment “Thinking Well” reasoning intervention to reduce delusional conviction, effect size 0.6 compared to standard care.
  • 4. 5. Vol. 32, No. 3, pp. 355-367, 1994 Chadwick, P.D.J. & Lowe, C.F. A cognitive approach to measuring and modifying delusions. Behav. Res. Ther. 3 studies completed on the measurement and modification of delusions in this study. The authors were influenced by verbal self-regulation of behavior and Maher’s work where he stated that a delusion experience.n was a normal attempt to make sense of abnormal perceptual experience. The patients who are distressed and puzzled over delusions try to make a meaningful explanation for them. Maher said that the meaning people make and the process they go through to get the meaning may not be too different than that of a person who has a “normal belief.” He said that” bizarre perceptions demand bizarre explanations.” He says that delusions are rational for what the individual is experiencing (auditory hallucination for example) and the people are incorrect. This study looked at paranoid, grandiose, control and identity delusions. Recent studies show that people with delusions have biased reasoning. 6. the effect of delusion and hallucination types on treatment response in schizophrenia and schizoaffective disorder This study looked at what effect the type of delusion and hallucination had on the treatment response of 116 inpatients all diagnosed with schizoaffective disorder. Religious and delusions of poisoning the most commonly noted. Patients with religious or grandiose delusions had the longest hospitalization and patients with sexual, religious and grandiose delusions had strong predictors for poor response to treatment. The same patients were prescribed more antipsychotic drugs and social functionality was less. Hallucinations did not affect therapy however visual hallucinations correlated with disease scores when patients were admitted.
  • 5. 7.Metacognitive Training for Delusion in Treatment-Resistant Schizophrenia: A Case Report People with schizophrenia have deficits in their metacognition, or “thinking about thinking.” this case report is about a 34-year- old woman with persecutory beliefs that did not respond to several courses of antipsychotics meds and ECT therapy. Metacognitive training was implanted between the patient and a therapist. The patient learned how jumping to conclusions about events without proper evidence could lead to an incorrect explanation, how emotions of self and others could be misinterpreted and how memory about something could get distorted. Usefulness for my Literature Review: I need to know if patients have deficits in their metacognition and how it relates to recovery. 8. Virtual reality in the treatment of persecutory delusions: randomized controlled experimental study testing how to reduce the delusional conviction See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/297893567 The efficacy of a new translational treatment for persecutory delusions: Study protocol for a randomised controlled trial (The Feeling Safe Study) Article in Trials · December 2016
  • 6. DOI: 10.1186/s13063-016-1245-0 CITATIONS 8 READS 250 7 authors, including: Some of the authors of this publication are also working on these related projects: A pilot study to investigate the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards: the INSITE trial. View project Health Economics related studies View project Felicity Waite University of Oxford 26 PUBLICATIONS 296 CITATIONS SEE PROFILE Linda Davies The University of Manchester 244 PUBLICATIONS 7,386 CITATIONS
  • 7. SEE PROFILE All content following this page was uploaded by Felicity Waite on 24 March 2016. The user has requested enhancement of the downloaded file. https://www.researchgate.net/publication/297893567_The_effic acy_of_a_new_translational_treatment_for_persecutory_delusio ns_Study_protocol_for_a_randomised_controlled_trial_The_Fee ling_Safe_Study?enrichId=rgreq- af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_2&_esc=publicationCoverPdf https://www.researchgate.net/publication/297893567_The_effic acy_of_a_new_translational_treatment_for_persecutory_delusio ns_Study_protocol_for_a_randomised_controlled_trial_The_Fee ling_Safe_Study?enrichId=rgreq- af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_3&_esc=publicationCoverPdf https://www.researchgate.net/project/A-pilot-study-to- investigate-the-feasibility-and-acceptability-of-a-cognitive- behavioural-suicide-prevention-therapy-for-people-in-acute- psychiatric-wards-the-INSITE-trial?enrichId=rgreq- af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_9&_esc=publicationCoverPdf https://www.researchgate.net/project/Health-Economics-related- studies?enrichId=rgreq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_9&_esc=publicationCoverPdf
  • 8. https://www.researchgate.net/?enrichId=rgreq- af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_1&_esc=publicationCoverPdf https://www.researchgate.net/profile/Felicity_Waite?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_4&_esc=publicationCoverPdf https://www.researchgate.net/profile/Felicity_Waite?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_5&_esc=publicationCoverPdf https://www.researchgate.net/institution/University_of_Oxford? enrichId=rgreq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_6&_esc=publicationCoverPdf https://www.researchgate.net/profile/Felicity_Waite?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_7&_esc=publicationCoverPdf https://www.researchgate.net/profile/Linda_Davies3?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_4&_esc=publicationCoverPdf https://www.researchgate.net/profile/Linda_Davies3?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_5&_esc=publicationCoverPdf https://www.researchgate.net/institution/The_University_of_Ma
  • 9. nchester?enrichId=rgreq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_6&_esc=publicationCoverPdf https://www.researchgate.net/profile/Linda_Davies3?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_7&_esc=publicationCoverPdf https://www.researchgate.net/profile/Felicity_Waite?enrichId=r greq-af16af27000ade791f82973e8e11d591- XXX&enrichSource=Y292ZXJQYWdlOzI5Nzg5MzU2NztBUzo zNDMwODYwMjc4MjEwNTZAMTQ1ODgwOTQ5MTE2NA%3 D%3D&el=1_x_10&_esc=publicationCoverPdf STUDY PROTOCOL Open Access The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study) Daniel Freeman1*, Felicity Waite1, Richard Emsley2, David Kingdon3, Linda Davies4, Ray Fitzpatrick5 and Graham Dunn2 Abstract Background: Persecutory delusions (strong unfounded fears that others intend harm to the person) occur in more than 70 % of the patients diagnosed with schizophrenia. This major psychotic experience is a key clinical target, for which substantial improvement in treatment is needed. Our aim is to use advances in theoretical understanding to develop a much more efficacious treatment that leads to
  • 10. recovery in at least 50 % of people with persistent persecutory delusions. Our cognitive conceptualisation is that persecutory delusions are threat beliefs, developed in the context of genetic and environmental risk, maintained by a number of psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering the feared situations after reduction of the influence of the maintenance factors. We have been individually evaluating modules targeting causal factors. These will now be tested together as a full treatment, called The Feeling Safe Programme. The treatment is modular, personalised, and includes patient preference. We will test whether the new treatment leads to greater recovery in persistent persecutory delusions, psychological well-being, and activity levels compared to befriending (that is, controlling for therapist attention). Methods/design: The Feeling Safe Study is a parallel group randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment in mental health services. Patients will be randomised (1:1 ratio) to The Feeling Safe Programme or befriending (both provided in 20 sessions over 6 months). Standard care will continue as usual. Online randomisation will use a permuted blocks algorithm, with randomly varying block size, stratified by therapist. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. The primary outcome is the level of delusional conviction at 6 months. Secondary outcomes include levels of psychological well-being, suicidal ideation, and activity. All main analyses will be intention-to-treat. The trial is funded by the NHS National Institute for Health Research.
  • 11. Discussion: The Feeling Safe study will provide a Phase II evaluation of a new targeted translational psychological treatment for persecutory delusions. Trial registration: Current Controlled Trials ISRCTN18705064 (registered 11 November 2015). Keywords: Paranoia, persecutory delusions, schizophrenia, psychosis, cognitive therapy * Correspondence: [email protected] 1Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK Full list of author information is available at the end of the article © 2016 Freeman et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Freeman et al. Trials (2016) 17:134 DOI 10.1186/s13063-016-1245-0 http://crossmark.crossref.org/dialog/?doi=10.1186/s13063-016- 1245-0&domain=pdf http://www.isrctn.com/ISRCTN18705064 mailto:[email protected]
  • 12. http://creativecommons.org/licenses/by/4.0/ http://creativecommons.org/publicdomain/zero/1.0/ Background Persecutory delusions, a central problem in schizophrenia, are unfounded beliefs that others are trying to harm the person [1]. Nearly half of patients with persecutory delu- sions have major depression [2]. Persecutory delusions predict serious violence [3], suicide [4], and hospital ad- mission [5]. It is well-recognised that treatments for perse- cutory delusions need significant improvement. The first line treatment, medication has effect sizes (standardised mean differences) varying between 0.33 and 0.88 (median = 0.44) [6], with problems of major side effects, poor com- pliance, and residual symptoms. In a review, Kennedy et al. [7] found that ‘almost 60 % of patients failed to achieve response after 23 weeks on antipsychotic drug therapy’. Meta-analysis for first generation psychological treatment (when added to medication) indicates an effect size of only 0.36 for delusions [8]. Psychological treatment is a valued treatment choice for patients, but problems of availability exist. For instance, in the United Kingdom only about 5 to 10 % of patients receive cognitive behavioural therapy (CBT) for psychosis [9]. Using advances in the understanding of the causes of persecutory delusions, our team have been developing a new targeted modular psychological treatment - called ‘The Feeling Safe Programme’ - with the aim of improving efficacy and deliverability. The translational studies leading to the trial At the core of a persecutory delusion is the belief that the person is unsafe [10]. New research shows that the heritability of paranoid thoughts is 50 % [11], indicating
  • 13. genetic and environmental risk leading to such fears. Once developed, the beliefs concerning danger are main- tained by six key factors [12] (see Fig. 1). For example, worry brings implausible ideas to mind, keeps them there, and exacerbates the distress; negative self-beliefs lead the person to feel inferior and vulnerable; subjectively anomalous internal states (for example, dissociation, unex- plained anxious arousal, and perceptual disturbances) provoke fearful explanations; disrupted sleep increases negative affect, mood dysregulation, and anomalous in- ternal states; reasoning biases prevent the processing of alternative explanations; and safety-seeking (defensive) be- haviours such as avoidance prevent the person receiving and processing disconfirmatory evidence that he or she is safe. Therefore treatment needs to target the maintenance factors before helping the patient to go into everyday situ- ations and relearn that they are safe. Our team have been developing and evaluating brief treatments targeting these maintenance factors. Brief, manualised interventions have been used in order to aid the theoretical interpretation, later dissemination, and the building of a combined treatment. The stron- gest test has been for reducing worry. A randomised controlled trial (‘The Worry Intervention Trial’) with 150 patients with persistent persecutory delusions was completed [13]. This had blind ratings and a 95 % follow-up rate. Targeting worry, in just six sessions, significantly reduced both worry and the persecutory delusions (both effect sizes = 0.5). A mediation analysis Fig. 1 The maintenance of persecutory delusions [12] Freeman et al. Trials (2016) 17:134 Page 2 of 8
  • 14. showed that two-thirds of the reductions in the delu- sions were due to reductions in worry. There were also significant increases in psychological well-being and re- ductions in overall psychiatric symptoms. A pilot ran- domised controlled trial (‘The Self-Confidence Study’) with 30 patients with persistent persecutory delusions, principally used techniques to enhance positive self-beliefs in order to limit the effects of negative self-beliefs [14]. Ratings were blind, and 100 % of the patients were followed up. Post treatment improvements were ob- served in positive self-beliefs (effect size = 1.0) and psy- chological well-being (effect size = 1.2) and reductions in negative self-beliefs (effect size = 0.24) and the delu- sions (effect size = 0.6). An assessor-blind, pilot rando- mised controlled trial (‘The Better Sleep Trial’) with 50 patients with persistent delusions and hallucinations showed that sleep can be substantially improved (effect size = 1.9) and that consequential benefits may exist in the levels of paranoia (effect size = 0.2) and quality of life (effect size = 0.5) [15]. A trial with several thousand uni- versity students with insomnia is now underway that will have sufficient power to test definitively the relation be- tween sleep improvement and paranoia [16]. Two recent randomised controlled studies have shown the benefits of reducing reasoning biases in patients with delusions [17, 18]. For example, in a pilot clinical study with 31 patients with persistent delusions, the ‘Thinking Well’ reasoning intervention led to a reduction in delusional conviction (effect size = 0.6) compared to standard care [18]. Most re- cently, we have shown that going into feared situations (that is, reducing avoidance) while dropping safety-seeking behaviours that prevent the full processing of disconfirm- atory evidence reduces delusions to a much greater extent than exposure alone (effect size = 1.3) [19]. All these ele- ments have now been combined as part of a full interven-
  • 15. tion, called The Feeling Safe Programme, delivered in 20 sessions over 6 months. The feasibility of this treatment has been recently established in a case series, and indica- tions exist of substantial clinical benefits for the patients [20]. The Feeling Safe Programme has been developed fur- ther on the basis of this case series. The new clinical trial The primary aim now is to test the efficacy in a single centre of this new theoretically-driven treatment for per- secutory delusions. The target group is those at most need: patients whose delusions have not responded to current treatment. The Feeling Safe Programme is antici- pated to lead to 50 % of patients having recovery in persist- ent persecutory delusions. We will test the intervention against an equal time receiving befriending (called ‘Feeling Safe and Supported’) from the same therapists. Befriending has benefits for patients with psychosis and in the short-term is comparable to first-generation cognitive- behavioural psychological therapies for psychosis [21, 22]. This choice of comparison allows us to determine whether the Feeling Safe Programme has benefits over and above the extra time spent with a therapist, which is important to determine for future training needs and service provision. The primary outcome will be conviction in the perse- cutory delusion, testing rates of recovery in the delu- sions (defined as conviction falling below 50 %, that is, greater doubt than certainty in the delusion) and di- mensional reductions in conviction levels. The Feeling Safe Programme is hypothesized to lead to lower levels of conviction in the persecutory delusions compared to befriending. Key secondary hypotheses are that the Feeling Safe Programme, compared to befriending, will
  • 16. lead to improved psychological well-being and activity levels compared to befriending. The Feeling Safe Programme, compared to befriending, is also predicted to lead to lower levels of overall paranoia, total delusion severity, and suicidal ideation. The primary endpoint will be the 6-month outcomes (that is, post-treatment) but the persistence of effects at a longer follow-up will also be tested (12 months). An explanatory component to the trial will be in- cluded. We will test whether changes in key mainten- ance factors (worry, self-beliefs, anomalous experiences, sleep, reasoning, safety-seeking behaviours) mediate change in delusions. We will also test whether working memory, illicit drug use, and levels of anger moderate treatment effects. We will record all service use, and other relevant health economic data, in order to carry out a health economic analysis. Methods The trial has received ethical approval from an NHS Research Ethics Committee (South Central – Oxford B Research Ethics Committee; ref 15/SC/0508) and has been registered (Current Controlled Trials ISRCTN18705064). Informed consent will be obtained from all participants. A Data Monitoring and Ethics Committee (DMEC), Trial Steering Committee (TSC), and Patient Advisory Group (PAG) have been formed. Design The design is a parallel group randomised controlled trial with single blind assessment to test whether the new psychological treatment will reduce persecutory de- lusions more effectively than befriending (an attention control condition) (see Fig. 2). Standard care will be measured but remain as usual in both groups. Assess-
  • 17. ments will be carried out at 0, 6 (post treatment), and 12 months. Freeman et al. Trials (2016) 17:134 Page 3 of 8 Participants Participants will be sought who have persistent perse- cutory delusions in the context of non-affective psych- osis. The inclusion criteria are male or female, aged 16 years or above; persistent (at least 3 months) perse- cutory delusion (as defined by Freeman and Garety [1]), held with at least 60 % conviction; and primary diagno- sis of schizophrenia-spectrum psychosis (non-affective psychosis). The exclusion criteria are current receipt of another psychological therapy; insufficient comprehen- sion of English; primary diagnosis of alcohol, drug, or personality disorder; in forensic settings; organic syn- drome; or learning disability. Referrals will be sought from Oxford Health NHS Foundation Trust and neigh- bouring NHS Trusts (for example, Northamptonshire Healthcare NHS Foundation Trust and Berkshire Healthcare NHS Foundation Trust). Randomisation and blinding The trial assessor will be blind to group allocation, but the patients and trial therapists will not be. Patient con- sent and assessments will be carried out by the trial assessor. Randomisation will occur after completion of the baseline assessment. An online randomisation sys- tem has been written by the University of Oxford Pri- mary Care Clinical Trials Unit. Randomisation using a permuted blocks algorithm, with randomly varying block size, will be stratified by therapist. Therapists will provide
  • 18. both interventions in order to reduce the confounding of therapist effects and increase statistical power. The trial co-ordinator will use the online system, after being pro- vided by the trial assessor with basic patient details (date of birth, gender). The trial coordinator will inform trial therapists who will then inform patients of the randomisation outcome, so that the research assessors remain blind to group allocation. Precautionary strategies to prevent breaks of the blind include the following: the patients being reminded by team members not to talk about treatment allocation; the assessor not looking at the patient’s clinical notes after the baseline assessment; and if an allocation is revealed between assessment sessions, then re-blinding with another assessor. We envisage conceal- ment of treatment allocation from the trial assessor will Fig. 2 Trial flow diagram Freeman et al. Trials (2016) 17:134 Page 4 of 8 be easier than treatment-as-usual comparison trials be- cause all patients are receiving a psychological interven- tion from the same therapists. Assessments Basic demographic and clinical data will be collected (for example, age, gender, ethnicity, and clinical diagnosis). The primary outcome measure will be conviction in the persecutory delusion (using a 0 to 100 % scale), assessed within the Psychotic Symptoms Rating Scale-Delusions scale [23]. Recovery is defined as the conviction in the de- lusional belief falling below 50 %; that is, there is greater
  • 19. doubt than belief in the delusion. Conviction greater than 50 % is a standard definition of the presence of a delusion (for example, [24]), although such beliefs are typically held with much greater certainty. For example, in our Feeling Safe Programme pilot study (n = 12), the initial conviction levels in the delusions showed a mean of 90 % (SD = 17) [20], and in a previous study with 100 patients with delu- sions, the mean conviction rating was 82 % (SD = 20) [25]. In the Worry Intervention Trial, at baseline, half of the 150 patients had 100 % conviction in the persecutory delu- sions [13]. Psychological well-being will be assessed by the Warwick-Edinburgh Mental Well-being Scale [26], health status by the EQ-5D-5 L (see http://www.euroqol.org/), quality of life by the Long Term Conditions Questionnaire (LTCQ) [27], and patient satisfaction using an adapted version of the CHOICE, a service user-led outcome meas- ure [28]. Activity levels will be assessed using a step count and a time-budget measure [29]. We will also include measures of overall paranoia (Green et al. Paranoid Thoughts Scale) [30], suicidal ideation (Columbia-Suicide Severity Rating Scale) [31], and depression (Beck Depres- sion Inventory) [32]. We will include the following as moderators: working memory [33], illicit drug use [34], and anger (Dimen- sions of Anger Reactions (DAR-5)) [35]. For mediation, we will include the following: the Penn State Worry Questionnaire [36], Brief Core Schema Scales [37], Specific Psychotic Experiences Questionnaire - halluci- nations subscale (SPEQ) [38], Insomnia Severity Index [39], jumping to conclusions [40] and belief flexibility [18], and the Safety Behaviours Questionnaire – Persecu- tory Beliefs [41]. We will record service use and other relevant health economic data using an adapted version of
  • 20. the Economic Patient Questionnaire [42] (EPQ) that includes questions from the Client Service Receipt Inventory [43]. In collaboration with the McPin Foundation, qualita- tive interviews will be carried out with a small number of patients and family members about the Feeling Safe Programme to assess the acceptability of the experimen- tal intervention. Adverse events We will check medical notes at the end of a patient’s participation for serious adverse events, including but not limited to: 1. All deaths. 2. Suicide attempts. 3. Violent in- cidents (needing police involvement) and 4. Formal com- plaints about therapy. We will also record any such event that we become aware of during a patient’s participation. All hospital admission data will also be recorded. The DMEC will determine relatedness of an event to the trial based on a temporalrelationship and whether the event is unexpected or unexplained given the participant’s clinical course, previous history, and concomitant treatments. Psychological interventions Both treatments are provided to patients individually in approximately 20 sessions over 6 months. Treatments will be provided by the trial clinical psychologists, with weekly supervision. The number of sessions and length will be re- corded, sessions will be taped when patients are agreeable, and tapes will be rated for fidelity and competence. Patient beliefs about the potential effectiveness of the intervention that he or she receives will be assessed after the first session with the Credibility/Expectancy Questionnaire [44], and therapeutic empathy will also be assessed with a patient questionnaire [45]. In The Feeling Safe Programme, following an assess-
  • 21. ment, the patient is offered a menu of appropriate treat- ment modules. Typically three to four modules are completed, based on patient preference. The range of modules that can be offered are improving sleep, redu- cing worry, increasing self-confidence, reducing the im- pact of voices, improving reasoning processes, and behavioural tests for reducing fear beliefs. Befriending, called in the trial ‘Feeling Safe and Supported’ will follow a protocol devised by one of the trial team members (DK) that has previously been used in two large clinical trials for patients with psychosis over 20 sessions [21, 22]. Essentially, the aim is to simulate how a good friend would respond and involves a general focus on non-threatening topics (although patients are not actively dissuaded from talking about concerns), non-confrontation, empathy, and supportiveness. Statistical and economic analysis plan A full statistical analysis plan will be written by the trial statisticians (RE, GD) prior to any analysis being under- taken. We will report data in line with the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement (http://www.consort-statement.org/consort-2010), showing attrition rates and loss to follow-up. All analyses will be car- ried out using the intention-to-treat principle with data from all participants in the analysis, including those who do not complete therapy. Every effort will be made to follow up all participants in both arms for research assessments. Freeman et al. Trials (2016) 17:134 Page 5 of 8 http://www.euroqol.org/ http://www.consort-statement.org/consort-2010
  • 22. Analysis will be conducted in Stata version 14 [46]. Descriptive statistics within each randomised group will be presented for baseline values. These will include counts and percentages for binary and categorical vari- ables and means and standard deviations, or medians with lower and upper quartiles, for continuous variables, along with minimum and maximum values and counts of missing values. There will be no tests of statistical sig- nificance or confidence intervals for differences between randomised groups on any baseline variable. Descriptive statistics will be used to summarize assess- ments of feasibility and acceptability in terms of recruit- ment, drop-out, and completeness of therapy. The primary hypothesis for change in the primary out- come measure, conviction in the persecutory delusion (using a 0 to 100 % scale) at 6 months, will be analysed using a linear regression model allowing for the base- line measurement of outcome, severity of delusion, therapist and treatment assignment as fixed effects. To compare rates of recovery (scores falling below 50 %), we will use logistic regression models instead of linear models. Secondary outcome measures will be analysed using the same modelling approach. This includes ana- lysis of the primary outcome and secondary outcomes at 12 months. The mediation analysis will investigate putative medi- ational factors using modern causal inference methods [47, 48]. This involves using parametric regression models to test for mediation of the Feeling Safe Inter- vention on outcome through the putative mediators. Analyses will adjust for baseline measures of the medi- ator, outcomes, and possible measured confounders. We will include repeated measurement of mediators
  • 23. and outcomes to account for classical measurement error and baseline confounding, and where feasible, use instrumental variable methods (baseline covariate by randomization interactions as potential instruments) to investigate the sensitivity of the estimates to these problems and that of unmeasured confounding. Moderators will be assessed separately by repeating the primary analysis models and including interaction terms between the randomised intervention and each moderator. The coefficient of the interaction term is a measure of whether the treatment effect differs between levels of the moderator. Missing data on individual measures will be pro- rated if more than 90 % of the items are completed; otherwise the measure will be considered as missing. We will check for differential predictors of missing outcomes by comparing responders to non-responders on key baseline variables. Any significant predictors will be included in the analysis models. This accounts for missing outcome data under a missing at random assumption, conditional on the covariates included in the model. As a sensitivity analysis, we will assess whether treatment adherence is associated with miss- ing data, and if it is associated, use inverse probability weights or multiple imputation to compare results. An economic evaluation will estimate the cost per quality adjusted life year (QALY) gained from a health and social care perspective over the 1-year timeframe of the trial. An economic model will be used to explore the potential cost effectiveness of the intervention over the patient’s lifetime. A detailed analysis plan for the eco- nomic evaluation will be prepared by the trial health
  • 24. economist (LMD) prior to the analysis. This will be in- formed by exploratory analyses of the pooled baseline data and published literature. For a recovery rate in delusions of 50 % in the Feeling Safe Programme, compared to 20 % with befriending, a study will have over 90 % power with 60 patients in each arm. The trial will, however, gain greater power by also examining change in delusion dimensional scores. If the standardised effect of the new interven- tion compared to befriending were smaller than 10 percentage points on the conviction scale (0 to 100 %) (d = 0.5), then we would not consider further develop- ment of the intervention to be worth pursuing. If the true effect size were this ten-point difference (SD = 20), then a two-sample t-test with a two-sided significance level of 0.05 would have 80 % power to detect a statis- tically significant effect with outcome data available for 64 participants per randomised arm. We aim to recruit 75 per arm. This conservatively allows for a drop-out of 15 %. Allowing for stratum membership and base- line levels of the measures in a more refined analysis of covariance will increase both statistical power and precision. Discussion Over the past 15 years, a significant advance has oc- curred in the understanding of the causes of paranoia. This research has predominately been from a cognitive perspective [12,49–52]. The advance in knowledge is be- ginning to be translated into treatment. From our theor- etical model, the clinical goal becomes to enable the patient to form a strong belief concerning current safety, thereby allowing the persecutory threat belief to dissi- pate. Hence the influence of the maintenance factors needs to be reduced and patients re-enter the threatening
  • 25. situations in order to learn directly that nothing adverse occurs. Toleration of the high anxiety, associated physio- logical arousal, and other anomalous experiences needs to occur. This learning of safety should allow a fundamental shift of attention away from activation of the negative valence system. From this perspective, clinical trials need to recruit patients on the presence of having persecutory delusions, and such delusions and related behaviours Freeman et al. Trials (2016) 17:134 Page 6 of 8 should become the main outcome. The Feeling Safe Study will be such an example. Translating our cognitive model, a series of studies of persistent persecutory delusions have shown the benefits of targeting the maintenance factors individually. The current trial aims to determine the efficacy, above that of simple therapist effects, of a full treatment based on the theoretical understanding. The potential is a substantial improvement in treatment for persistent persecutory delusions. Outcome results are expected in 2020. Trial status The trial is due to start patient recruitment in February 2016. Abbreviations CBT: cognitive behavioural therapy; CHOICE: Choice of Outcome In CBT for Psychoses; CONSORT: Consolidated Standards of Reporting Trials; CSRI: Client Service Receipt Inventory; DAR-5: Dimensions of Anger Reactions; DMEC: Data Monitoring and Ethics Committee; EPQ: Economic
  • 26. Patient Questionnaire (EPQ); EQ-5D-3 L: EuroQual Five Dimensions Three Levels; LTCQ: Long Term Conditions Questionnaire; NHS: National Health Service; PAG: Patient Advisory Group; QALY: quality-adjusted life year; SPEQ: Specific Psychotic Experiences Questionnaire; TSC: Trial Steering Committee.. Competing interests The authors declare that they have no competing interests. Authors’ contributions DF conceived the study and is the chief investigator. All study authors contributed to the design of the trial. FW will coordinate the study. DF will supervise the psychological interventions. DK will advise on the befriending intervention. GD and RE will carry out the outcome, moderation, and mediation analyses. LD will carry out the health economic evaluation. RF will lead on the qualitative study. All authors read and approved the final manuscript. Acknowledgements The trial is funded by an NIHR Research Professorship awarded to DF. The funder reviewed the design of the trial but did not make any alterations or have a role in writing or submitting this paper for publication. This paper presents independent research funded by the National Institute for Health
  • 27. Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Author details 1Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK. 2Centre for Biostatistics, Institute of Population Health, Manchester University, Manchester Academic Health Centre, Manchester, UK. 3Academic Department of Psychiatry, Faculty of Medicine, University of Southampton, Southampton, UK. 4Centre for Health Economics, Institute of Population Health, Manchester University, Manchester Academic Health Centre, Manchester, UK. 5Nuffield Department of Population Health, University of Oxford, Oxford, UK. Received: 30 January 2016 Accepted: 19 February 2016 References 1. Freeman D, Garety PA. Comments on the content of persecutory delusions: Does the definition need clarification? Br J Clin Psychol. 2000;39:407–14. 2. Vorontsova N, Garety P, Freeman D. Cognitive factors maintaining persecutory delusions in psychosis: the contribution of depression. J Abnorm Psychol. 2013; 122:1121–31.
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  • 34. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;1990:487–95. 37. Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, et al. The Brief Core Schema Scales (BCSS): Psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006;36:749–59. 38. Ronald A, Sieradzka D, Cardno AG, Haworth CMA, McGuire P, Freeman D. Characterization of psychotic experiences in adolescence using the Specific Psychotic Experiences Questionnaire (SPEQ): Findings from a study of 5000 16-year-old twins. Schizophr Bull. 2014;40:868–77. 39. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2:297–307. 40. Garety PA, Freeman D, Jolley S, Dunn G, Bebbington PE, Fowler DG, et al. Reasoning, emotions and delusional conviction in psychosis. J Abnorm Psychol. 2005;114:373–84. 41. Freeman D, Garety PA, Kuipers E. Persecutory delusions: developing the understanding of belief maintenance and emotional distress. Psychol Med. 2001;31:1293–306.
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  • 36. trials of complex interventions: a methodological research programme. Health Technol Assess. 2015; 19(93). http://dx.doi.org/10.3310/hta19930. 49. Garety P, Freeman D. The past and future of delusion research. Br J Psychol. 2013;203:327–33. 50. Freeman D, Garety P. Advances in understanding and treating persecutory delusions. Soc Psychiatry Psychiatr Epidemiol. 2014;49:1179– 89. 51. Dudley R, Taylor P, Wickham S, Hutton P. Psychosis, delusions and the “jumping to conclusions” reasoning bias: a systematic review and meta- analysis. Schizophr Bull. 2015. doi:10.1093/schbul/sbv150 52. Kesting M, Lincoln T. The relevance of self-esteem and self-schemas to persecutory delusions. Compr Psychiatry. 2013;54:766–89. • We accept pre-submission inquiries • Our selector tool helps you to find the most relevant journal • We provide round the clock customer support • Convenient online submission • Thorough peer review • Inclusion in PubMed and all major indexing services • Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit
  • 37. Submit your next manuscript to BioMed Central and we will help you at every step: Freeman et al. Trials (2016) 17:134 Page 8 of 8 View publication statsView publication stats http://dx.doi.org/10.3310/hta19930 https://www.researchgate.net/publication/297893567AbstractBa ckgroundMethods/designDiscussionTrial registrationBackgroundThe translational studies leading to the trialThe new clinical trialMethodsDesignParticipantsRandomisation and blindingAssessmentsAdverse eventsPsychological interventionsStatistical and economic analysis planDiscussionTrial statusAbbreviationsCompeting interestsAuthors’ contributionsAcknowledgementsAuthor detailsReferences Schizophrenia Research 165 (2015) 243–246 Contents lists available at ScienceDirect Schizophrenia Research journal homepage: www.elsevier.com/locate/schres Jumping to conclusions and the persistence of delusional beliefs in first episode psychosis M. Aurora Falcone a,b,⁎, Robin M. Murray b, Jennifer A. O'Connor b, Leanne N. Hockey b, Poonam Gardner-Sood b, Marta Di Forti b, Daniel Freeman c, Suzanne Jolley a
  • 38. a King's College, London, Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, London, UK b King's College, London, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, London, UK c University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, UK ⁎ Corresponding author at: Department of Psychos Psychiatry, Psychology & Neuroscience, De Crespigny Tel.: +44 207 848 0100; fax: +44 207848 0287. E-mail address: [email protected] (M.A. Falcon http://dx.doi.org/10.1016/j.schres.2015.04.019 0920-9964/© 2015 Elsevier B.V. All rights reserved. a b s t r a c t a r t i c l e i n f o Article history: Received 29 November 2014 Received in revised form 28 February 2015 Accepted 15 April 2015 Available online 6 May 2015 Keywords: Psychosis Delusions Reasoning Jumping to conclusions Neuropsychology Background: Cognitive biases may contribute to delusion persistence. We tested this in a longitudinal study of first episode psychosis (FEP).
  • 39. Methods: 34 FEP patients completed assessments of delusions and Jumping to Conclusions (JTC) at baseline and 12-month follow-up. Results: JTC was associated with baseline delusion severity (t(32) = 2.7, p = 0.01). Baseline delusions persisted at follow-up for 8/20 participants (40%), who all jumped to conclusions (8/8, 100%), compared to half of those with no or changeable delusions (14/26, 54%; χ2 (df = 1) = 5.7, p = 0.03; Phi = 0.4). Conclusion: Findings implicate cognitive biases in delusion persistence, and support the potential to reduce delu- sions through reasoning-focused interventions. © 2015 Elsevier B.V. All rights reserved. 1. Introduction The Jumping to Conclusions (JTC) bias is a tendency to make decisions with certainty based on limited data-gathering. There is substantial support for its presence in patients with delusions (Fine et al., 2007; Garety et al., 2011; So et al., 2012; Garety and Freeman, 2013; Jolley et al., 2014), and emerging evidence of associations with outcome and change in delusions, both as a potential marker for response to antipsy- chotic medication (Andreou et al., 2014; Menon et al., 2008; So et al., 2014) and a manipulable target of psychological intervention (e.g. Garety et al., 2014; Lincoln et al., 2014; Moritz et al., 2013; Sanford et al., 2013; Warman et al., 2013). To date, only one study has investigated JTC and delusion
  • 40. persistence in first episode psychosis (FEP; Dudley et al., 2013). Dudley and col- leagues found persistent JTC and delusions to be associated at follow- up, but no baseline associations, providing only partial support for a maintaining role of JTC. Possible reasons for the failure to find baseline associations include subjective rating of delusions according to the di- mension of distress and low baseline rates of JTC and delusion severity. Our own previous work showed that, when using objective assessments is Studies, PO 52, Institute of Park, London SE5 8AF, UK. e). of delusions, in a FEP group with rates of delusions and JTC comparable to those found in established psychosis, the baseline association of the JTC bias with delusion severity was replicated (Falcone et al., 2014). The current study is a longitudinal follow-up of the same participants at 12-months. Our aim was to investigate the association of the JTC bias with delusion persistence, as persistent delusions are the targets of psychological intervention. We hypothesised firstly that we would replicate the association of JTC with delusion severity at baseline
  • 41. (i.e. during a psychotic episode) found in our larger sample, and secondly that the persistence of delusions at a clinical level of severity would be associated with the tendency to JTC. 2. Methods 2.1. Participants Thirty-four participants (31% of the baseline sample (n = 108) re- ported by Falcone et al., 2014) completed measures of delusions and reasoning at both baseline and 12-month follow-up. All participants completing study measures at the two time points were included. Par- ticipants were assessed as part of the Genetics and Psychosis (GAP) study (Di Forti et al., 2012; O'Connor et al., 2012; Stilo et al., 2013; Wiffen et al., 2014) which was designed to identify genetic and environ- mental factors associated with psychosis. Ethical approval was granted by the joint Institute of Psychiatry and South London and Maudsley http://crossmark.crossref.org/dialog/?doi=10.1016/j.schres.2015 .04.019&domain=pdf http://dx.doi.org/10.1016/j.schres.2015.04.019 mailto:[email protected] Journal logo http://dx.doi.org/10.1016/j.schres.2015.04.019 http://www.sciencedirect.com/science/journal/09209964
  • 42. Table 1 Demographic and clinical characteristics at baseline and follow- up. Baseline (n = 34) Follow-up (n = 34) p Mean (SD) Age in years 27.9 (7.9) 29.1 (7.7) [Range] [18–50] [19–51] PANSS delusion severity 2.7 (1.4) 2.2 (1.6) t = 1.8 (df = 33), p = 0.08 [Range] [1–6] [1–6] n (%) JTC 85:15 14 (41) 13 (38) 60:40 9 (26) 10 (29) Either 15 (44) 14 (41) p = 1.0a 244 M.A. Falcone et al. / Schizophrenia Research 165 (2015) 243–246 NHS Foundation Trust Research Ethics Committee; all participants gave informed written consent. GAP clinical inclusion criteria were: a current diagnosis of first episode psychosis (determined by
  • 43. clinical interview according to OPCRIT and DSM-IV criteria (APA, 1994; McGuffin et al., 1991)); within six months of first contact with services; current psychotic symptoms, experienced for at least seven days; age 18–65 years. Exclusion criteria were: a history of moderate or severe learning disabilities, or current IQ b 70, as assessed by the Wechsler Adult Intelligence Scale—Third Edition (Wechsler, 1997); insufficient command of English to complete assessments; a history of previous contact with mental health services for psychosis; a primary diagnosis of alcohol or substance dependency or a known organic cause of psychosis. Delusion presence 20 (59%) 13 (38%) p = 0.03a Diagnosis Schizophrenia 8 (23) Schizophreniform disorder 5 (15) Psychotic disorder NOS 6 (18) Schizoaffective disorder 4 (12) Affective disorder with psychosis 11 (32) Key: PANSS, Positive and Negative Syndrome Scale; JTC, Jumping to Conclusions. a McNemar test; NOS: not otherwise specified. 2.2. Measures Demographic data were collected by self-report, supplemented by clinical records. The delusion item of the Positive and Negative
  • 44. Syndrome Scale (PANSS; Kay et al., 1987) provided ratings of mean delusion severity (from 1 (absent) to 7 (extremely severe)). Delusion presence (rating ≥3 (mild)) was dichotomised into persistent (present at baseline and 12-month follow-up) or not (absent/present only once). Jumping to Conclusions (JTC): Two versions of the Probabilistic Rea- soning ‘Beads’ Task (Garety et al., 2005) were employed, with beads in 85:15 and 60:40 ratios. Participants were shown two jars containing coloured beads in opposite ratios (e.g., mainly black: 85 black and 15 orange beads; mainly orange: 85 orange and 15 black beads), then a series of beads, one at a time, drawn from one of the two jars randomly selected by the computer. Participants were asked to request as many beads as they needed to be certain of the jar of origin. Deciding after fewer than three beads was classified as JTC. As we were concerned with the potential for the bias to influence day-to-day decision- making, rather than its consistency between tasks, or over time, we con- sidered a single hasty decision on any task, at any time point to be evi- dence of the tendency to JTC, and rated this dichotomously (no JTC/JTC at least once; Garety et al., 2005; Jolley et al., 2014; So et al., 2012).
  • 45. 2.3. Analyses Data were analysed using the Statistical Package for the Social Sciences Version 20.0 (IBM, 2011). Rates of JTC and delusions and delu- sion severity were compared at baseline and follow-up using McNemar tests and paired sample t-tests. For hypothesis one, severity of delusions between JTC groups at baseline was compared using independent sample t-tests. For hypothesis two, rates of JTC between those with and without persistent delusions were compared using Chi-square tests. 3. Results Demographic and clinical characteristics are shown in Table 1. Participants were predominantly male (22/34, 65%) and of Black or Minority Ethnic (BME) background (23/34, 68%). 3.1. Hypothesis 1: JTC will be associated with the severity of delusions at baseline The findings replicated our previous report (Falcone et al., 2014), with more severe delusions in those showing the JTC bias (JTC mean: 3.4 (SD 1.4); no JTC mean: 2.2 (SD 1.2), t = 2.7, df = 32, p = 0.01). Of the 20 participants with delusions at baseline, 55% (11/20) jumped to conclusions, compared to 29% of those without delusions (4/14). 3.2. Hypothesis 2: JTC will be associated with the persistence of delusions at
  • 46. follow-up Overall rates of JTC remained consistent, with two thirds showing the bias at least once (22/34; 65%), though only seven individuals showed the bias consistently (Table 2). Rates of delusions reduced, with a non-significant reduction in delusion severity (Table 1). Nearly half of those with delusions at baseline had persisting delusions at follow-up (8/20; 40%), and all those with persisting delusions jumped to conclusions at least once (8/8, 100%), compared to half of those with no (6/11) or changeable (8/15) delusions (14/26, 54%; χ2 (df = 1) = 5.7, p = 0.03; Phi = 0.4; Table 2). 4. Discussion We tested associations of the JTC reasoning bias with delusion per- sistence in FEP. The prevalence and severity of delusions and rates of JTC in followed-up participants matched our previous, larger study (Falcone et al., 2014), suggesting that this subsample comprised repre- sentative participants. At baseline, during participants' first psychotic episode, the well-established association of delusion severity with JTC was replicated. Over time, rates of JTC remained stable, but individual participants showed variation in their data-gathering, with only a third never jumping to conclusions. Delusions mostly improved
  • 47. over time, but persisted for around half of participants. All participants with persisting delusions jumped to conclusions at least once, compared to only half of those with no or changeable delusions. The association of JTC with delusion persistence was significant, with a medium to large effect size. Limitations of the study include the small number of partic- ipants followed up from baseline (31%); that we did not control for the effects of medication or any other treatments; and that data on age of onset were not collected for this study. The mean delusion scores presented in Table 2 are based on small numbers, and are reported to explicate the results, rather than to represent a reliable statistical average. We operationalised JTC as a dichotomous variable, using the criterion of fewer than three beads to indicate the presence of the bias. Analyses of the number of draws to decision, or employing an alternative dichotomy, were not carried out, and may have given different results. Finally, notwithstanding the longitudinal design of the study, we did not test whether the bias precedes the development of delusions, and a causal role for the bias in the onset of delusions cannot be inferred from these results.
  • 48. Table 2 Number of participants showing each pattern of change in Jumping to Conclusions (JTC) and delusions over time, with mean delusiona severity scores (SD) at baseline (BL) and follow-up (FU). Delusion-free at least once Persistent Delusions Total No delusions at BL or FU Delusions at BL only Delusions at FU only No JTC BL 1.2 (0.4) 3.5 (0.5) 1.0 (–) – 2.3 (1.3) FU 1.2 (0.4) 1.5 (0.5) 6.0 (–) – 1.75 (1.4) n 5/11 6/12 1/3 0/8 12/34 JTC at least once BL 1.3 (0.5) 3.5 (0.8) 2.0 (0) 4.0 (1.2) 3.0 (1.4) FU 1.0 (0) 1.0 (0) 3.5 (0.7) 4.3 (0.9) 2.4 (1.7) n 6/11 6/12 2/3 8/8 22/34 - JTC at BL only BL 2.0 (–) 3.3 (0.6) – 4.5 (1.3) 3.8 (1.3) FU 1.0 (–) 1.0 (0) – 4.7 (1.0) 2.9 (2.1) n 1 3 0 4 8 - JTC at FU only BL 1.3 (0.5) 3.0 (–) – 3.0 (0) 2.0 (1.0) FU 1.0 (0) 1.0 (–) – 4.0 (0) 1.9 (1.5) n 4 1 0 2 7
  • 49. - JTC at BL & FU BL 1.0 (–) 4.0 (1.4) 2.0 (0) 4.0 (1.4) 3.0 (1.5) FU 1.0 (–) 1.0 (0) 3.5 (0.7) 3.5 (0.7) 2.4 (1.4) n 1 2 2 2 7 Total BL 1.3 (0.5) 3.5 (0.7) 1.7 (0.6) 4.0 (1.2) 2.7 (1.4) FU 1.1 (0.3) 1.3 (1.4) 4.3 (1.5) 4.3 (0.9) 2.2 (1.6) n 11 12 3 8 34 Key: JTC, Jumping to Conclusions; BL, baseline; FU, follow- up. a Measured by the PANSS (Kay et al., 1987). 245M.A. Falcone et al. / Schizophrenia Research 165 (2015) 243–246 Our findings do support a maintaining role for the JTC bias in delusions. They also support the growing evidence base showing the effectiveness of targeted interventions to modify JTC, such as the Maudsley Review Training Programme (Waller et al., 2011), Metacognitive Training (MCT; Moritz et al., 2014a, 2014b) and Social Cognition and Interaction Training (SCIT; e.g. Roberts et al., 2014), in reducing delusion persistence and improving outcomes for people with psychosis. We thank the study participants for their time, and the GAP team. This work was supported by the NIHR Biomedical Research Centre for Mental Health at the South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Psychology & Neuroscience,
  • 50. King's College London; the Institute of Psychiatry, Psychology & Neuroscience at King's College London; and the Psychiatry Research Trust. DF is sup- ported by a Medical Research Council Senior Clinical Fellowship. Role of the funding source This work was supported by the NIHR Biomedical Research Centre for Mental Health at the South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Psy- chology & Neuroscience, King's College London; the Institute of Psychiatry, Psychology & Neuroscience at King's College London; and the Psychiatry Research Trust. DF is supported by a Medical Research Council Senior Clinical Fellowship (G0902308). Acknowledgement We thank the study participants for their time, and the GAP team. References American Psychiatric Association, 1994. Diagnostic and Statistical Manual of Mental Disorders—Fourth Edition (DSM-IV). American Psychiatric Association, Washington, DC. Andreou, C., Moritz, S., Veith, K., Veckenstedt, R., Naber, D., 2014. Dopaminergic modula- tion of probabilistic reasoning and overconfidence in errors: a double-blind study.
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  • 57. Administration and Scoring Manual. The Psychological Corporation, San Antonio, TX. Wiffen, B.D.R., O'Connor, J.A., Russo, M., Falcone, M.A., Joseph, C., Kolliakou, A., David, A.S., 2014. Do psychosis patients with poor insight show implicit awareness on the emo- tional Stroop task? Psychopathology 47 (2), 93–100. http://refhub.elsevier.com/S0920-9964(15)00210-8/rf0125 http://refhub.elsevier.com/S0920-9964(15)00210-8/rf0125 http://refhub.elsevier.com/S0920-9964(15)00210-8/rf0130 http://refhub.elsevier.com/S0920-9964(15)00210-8/rf0130 http://refhub.elsevier.com/S0920-9964(15)00210-8/rf0135 http://refhub.elsevier.com/S0920-9964(15)00210- 8/rf0135Jumping to conclusions and the persistence of delusional beliefs in first episode psychosis1. Introduction2. Methods2.1. Participants2.2. Measures2.3. Analyses3. Results3.1. Hypothesis 1: JTC will be associated with the severity of delusions at baseline3.2. Hypothesis 2: JTC will be associated with the persistence of delusions at follow-up4. DiscussionRole of the funding sourceAcknowledgementReferences Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Psychiatric Disorders Characterized by Delusions: Treatment in Relation to Specific Types Munro, Alistair, MD, FRCPC Psychiatric Annals; May 1992; 22, 5; ProQuest Central pg. 232
  • 58. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
  • 59. Pergamon Behav. Res. Ther. Vol. 32, No. 3, 355-367, 1994 pp. Copyright 0 1994 Elsevier Science Ltd 00057967(93)EOO12-T Printed in Great Britain. All rights reserved 0005-7967/94 $6.00 + 0.00 A COGNITIVE APPROACH TO MEASURING AND MODIFYING DELUSIONS P. D. J. CHADWICK’* and C. F. LOWE* ‘School of Psychology, University of Birmingham, Edgbaston, Birmingham B15 2TT, U.K 2University College of North Wales, University of Wales, Bangor, U.K. (Received 11 May 1993) Summary-The present paper summarizes and integrates with the existing literature the results of three studies we have conducted on the measurement and modification of delusions. The findings of two of these studies have been presented previously; the third is briefly reported here. A total of 12 people with delusions took part. Ten participated in two investigations that used between-subject multiple-baseline designs; the remaining two, each of whom held three distinct delusions, took part in a study using an across-beliefs multiple-baseline design. A variety of dimensions of delusional experience were monitored over baseline periods of at least 4 weeks, and two distinct cognitive interventions were used: a structured
  • 60. verbal challenge and a planned empirical test. Our focus in the present article is on intervention and the process of change as people come to question and sometimes reject their delusions. We also address related issues, including problems of measurement (i.e. demand characteristics, independent validation), the connection between depression and delusions and the prediction of treatment response. We conclude with specific recommendations for cognitive therapy for delusions. THE COGNITIVE PERSPECTIVE ON DELUSIONS Our theoretical perspective on delusions has been influenced by two main sources, the literature on verbal self-regulation of behaviour (Lowe, 1979; Lowe, Horne & Higson, 1987) and Maher’s (1974, 1988) work on delusions. Our interest has been on the common features of delusional thinking. Thus, our experimental strategy has been directed at a variety of delusion types (paranoid, grandiose, control and identity). Maher (1974, 1988) proposed that a delusion can be regarded as a normal attempt to make sense of an abnormal perceptual experience. A clear paradigm case would be a delusion that was secondary to auditory hallucinations, the argument here being that the hallucinations puzzled and perhaps distressed the individual concerned, and so he or she searches for a meaningful explanation of them. The delusion would arise from this effort after meaning, and would be invested with the psychological force of having rid the individual of the sense of bewilderment. According to Maher, the reasoning processing that produces delusions does not differ from that which produces so-called ‘normal’ beliefs; it is just that bizarre perceptions
  • 61. demand bizarre explanations. Maher’s contention that a delusion may be rational, although incorrect, has been questioned recently with the discovery that people with delusions have biased reasoning (see Bentall, Kinderman & Kaney, 1994, this issue pp. 331-341). Under certain experimental conditions people with delusions appear to show bias in their attributional style, in their judgement of covariance, and in their probabilistic reasoning (Garety, 1991). However, this raises a number of consider- ations. First, it is sometimes difficult to interpret such findings vis-ci-vis rationality. For example, Huq, Garety and Hemsley (1988) using a neutral task which required subjects (Ss) to make inferences about the likely ratio of different coloured beads in a jar, investigated the probabilistic reasoning of a group of deluded people, a group of mixed psychiatric patients who were not deluded and a group of matched controls. People with delusions were found to require the least beads to be drawn from the jars before forming their conclusions and also to express most confidence in their decisions, and yet this ‘jumping to conclusions’ was nearer optimum reasoning than the caution displayed by other Ss. Also, it is not always clear how specific findings in analogue studies might apply to delusional thinking. For example, how might it be established if delusions are *Author for correspondence. 355
  • 62. 356 P. D. J. CHADWICK and C. F. LOWE formed on the basis of less information than, say, religious beliefs or depressive beliefs? Second, the evidence is for bias, not deficit; it might reasonably be inferred that the observed bias is a consequence of delusional behaviour, rather than the delusion being a consequence of the bias. TO distinguish between rational and irrational thinking is not straightforward, Indeed, it may be that debate about the rationality of delusions runs the risk of obscuring the main value in Maher’s theory-i.e. that in delusions the primary underlying motivation is attributional, and that they may be thought of as an attempt to make sense of particular events. (It has been an integral part of our approach to challenging delusions that the person be encouraged to construe his or her delusion as a reaction to, and an attempt to make sense of, particular events, and that an alternative perspective from which to understand these events be supplied and evaluated.) Viewing delusions in this way has some interesting implications. One is that although delusions may not be culturally shared, they are grounded in external events. In an important sense the person, not a hidden pathology, constructs the belief. A related implication, which is born out in our research, is that people can presumably describe some, or perhaps all, the experience (‘evidence’), their delusions were invoked to explain, and their accounts might shed light on the process of delusion formation.
  • 63. Maher’s perspective agrees well with the writing of Vygotsky (1962) and Luria (1961) who charted the developmental process by which language gradually acquires a regulatory function and comes to organize and drive behaviour. The regulatory function of language is surprisingly potent. For example, simply giving objects a label appears to allow young children to use them in a way that was not possible before, and also helps to abstract the principle that guided this organization and apply it elsewhere (Luria, 1961). Delusions, like other beliefs, alter our relation to the environment, because they organize and structure future experience. It is important to recognize that a beliefs regulatory potency does not hinge on its accuracy, nor on the degree to which it is the result of reason, nor on its adaptive value. Several studies of human learning have shown that the rules people form about contingencies of reinforcement are often not based on correct inference and do not produce optimum responding, yet they exercise a unique control over behaviour and are extremely resistant to change (Lowe, 1979, 1983; Horne & Lowe, 1993). According to this account, there are important respects in which delusions are like other beliefs. This new emphasis on continuity, rather than discontinuity, is nowhere more evident than in the literature on defining and measuring delusions. Traditionally, delusions have been defined on the basis of empirical claims of discontinuity- e.g. as beliefs that were undeniably false, that were held with total and unshakable conviction, that were not shared by others with the same cultural background and that were based on
  • 64. incorrect inference (DSM-III-R; APA, 1987). Individually these criteria have been disputed: thus, a delusion need not be false (Brockington, 1991), it need not be held with absolute or unshakable conviction (Brett-Jones, Garety & Hemsley, 1987; Watts, Powell & Austin, 1973) and it need not be based on incorrect inference (Garety, 1991). The criterion relating to the unusual content of delusions also may be questioned, since research has demonstrated how difficult it is to rate the ‘bizarreness’ of delusions (Kendler, Glazer & Morgenstern, 1983). Traditional criteria have also been challenged by a radical and exciting call to define delusions as points on a continuum with normality, the position on this continuum being influenced by dimensions of delusional experi- ence such as degree of belief conviction and the extent of preoccupation with the belief (Strauss, 1969). As well as stressing continuity, this new perspective also places great emphasis on the individual and on individual differences. For this reason, in our three studies we used multiple-baseline methodology (Kazdin, 1982) with its combination of experimental control together with the power to reveal individual diversity. Before, during, and after therapy, we measured the degree of conviction with which the delusion was held, the degree of preoccupation with the delusion, the concurrent degree of anxiety and the extent to which the person observed confirmations and disconfirmations. We also gave the Beck Depression Inventory (BDI; Beck, Rush, Shaw & Emery, 1979) during baseline, intervention, and follow-up to assess for unwanted effects of the loss
  • 65. or weakening of a delusion. One of the most striking aspects of our findings on the modification of delusions was the very individual nature of the process and outcome of change, and for this reason we strongly favour the use of sophisticated single- subject methodology in this field. Cognitive approach to delusions 357 ARE DELUSIONS OPEN TO MODIFICATION? On occasion, psychiatric opinion appears to be absolutistic and very difficult to change. For example, it is often asserted that delusions cannot be modified or are utterly insensitive to reason (see Garety, 1985) and yet there are empirical grounds for rejecting this opinion. There has been a modest number of studies, including our own, reporting attempts to weaken delusions, with generally favourable results (Alford, 1986; Beck, 1952; Fowler & Morley, 1989; Hartman & Cashman, 1983; Hole, Rush & Beck, 1973; Johnson, Ross & Mastria, 1977; Milton, Patwa & Hafner, 1978). Whilst it is important to admit some methodological shortcomings, and the need to develop better measures and therapies, it seems unwise to deny a priori these findings and their implications. It might be more reasonable to assert that delusions are difficult to modify, sometimes fiendishly so. This position would acknowledge that the class of beliefs called delusions varies considerably along a number of dimensions, and it would encourage
  • 66. examination of the multitude of factors which might be thought to influence therapeutic outcome. It would also encourage an exploration of whether delusions associated with a diagnosis of schizophrenia are more difficult to modify than political or religious beliefs, or the core beliefs associated with conditions such as depression and anorexia. It is, of course, as fallacious to accept research uncritically as to reject it out of hand. Research on modifying delusions is in its infancy, and there are methodological and conceptual problems that render many of the findings suggestive rather than definitive. We are nevertheless optimistic that psychological therapy has a role to play, as we hope our findings will demonstrate, but we recognize the need for caution and for critical appraisal of current theories and methods. COGNITIVE THERAPY FOR DELUSIONS: AN EXPERIMENTAL ANALYSIS We carried out three studies on the use of cognitive therapy (CT) to weaken delusional thinking in people with a diagnosis of schizophrenia. In total, 12 outpatients took part, 8 men and 4 women, all of whom were on stable neuroleptic medication. They ranged in age from 28 to 63 years (average 36). All described clear delusions, which had been voiced at varying points over at least the preceding 2 years, though usually far longer. However, it should be noted that though delusions may be mentioned over a number of years, this is not necessarily an accurate guide as to how long they have been held (Strauss, 1991).
  • 67. CT usually pursues cognitive change through a combination of verbal challenge and planned reality testing (Beck et al., 1979). In our research on delusions we used each of these strategies in separate interventions, and manipulated the order in which they were introduced in an attempt to understand more about how each works. Both interventions were applied within an atmosphere of ‘collaborative empiricism’ (Beck et al., 1979). Rather than being told that they were wrong, individuals were encouraged to see their delusions as being only one possible interpretation of events and they were asked to consider and evaluate an alternative view. Also, because of our dissatisfaction with current definitions of schizophrenia and delusion, in speaking to the individuals we did not use these labels to describe their experience. The verbal challenge comprised four elements. To minimize the likelihood of psychological reactance (Brehm, 1962) the evidence for the beliefs was challenged first; the order in which each piece of evidence was challenged was inversely related to its importance to the delusion (see Watts et al., 1973). An integral part of this discussion involved the therapist making clear to individuals how strongly held beliefs can exert a profound influence over their behaviour and interpretation of events. Second, the internal consistency and plausibility of the belief system was questioned, and all irrational or inconsistent features were highlighted. Third, following Maher, an alternative perspective was offered, namely, that the belief was formed in response to, and as a way of making sense of, a specific experience-often this included a primary
  • 68. symptom, but in several cases it was hypothesized that the delusion was in part a response to important life events. For example, a link was drawn and discussed between patient DR’s belief that he could communicate with people from the past, and thereby prevent accidents and disasters, and the accidental death of his father shortly 358 P. D. J. CHADWICK and C. F. LOWE before the onset of symptoms. Lastly, the individual’s delusion and the therapist’s alternative were assessed in light of the available information. The main feature of our reality testing intervention was that it involved the individual planning and performing an activity that could invalidate the delusion, or some part of it (Hole et al., 1973). Beck et al. (1979) called such activities behavioural experiments, conveying that they were performed in order to test a hypothesis. Strategically, the primary purpose of both empirical testing and verbal challenge is to bring about cognitive change, although empirical testing is thought to be the more powerful intervention. As Beck put it: “There is no easy way to ‘talk the patient out’ of his conclusions that he is weak, inept, or vacuous By helping the patient change certain behaviours, the therapist may demonstrate to the patient that his negative, overgeneralized conclusions were incorrect.” (Beck el al., 1979, p. 118. original emphasis.) The effects of the interventions on three outcome measures
  • 69. (conviction, preoccupation and Conviction Preoccupation Anxietv TD 100 5 4 100 50 0 100 50 s 5 0 ._ ‘, ‘5 100 g V 50 0
  • 70. EE 50 3 2 1 0 0 Baseline Verbal Reality Follow-up challenge tesring Fig. 1. Bar graph summarizing 6 individuals’ (HM, TD, WH, EE, MM & DR) weekly conviction, preoccupation and anxiety scores during baseline, verbal challenge, reality testing and follow-up. Cognitive approach to delusions HI IC onviction 359 100 5 4 3 50 2
  • 71. 1 0 0 x 100 5 z ._ 4 2 3 ‘c) g 50 2 5 C z 1 .8 ‘- 6 0 0 ; ._ 2 100 5 :: 6 4 s EL 50 3 2 z 5 1 :: 0 Ozz 100 5 4
  • 72. 3 50 2 1 ” 0 Baselille Reality Verbal Follow-up testing challenge Fig. 2. Bar graph summarizing 4 individuals’ (HJ. LJ, CE & FD) weekly conviction, preoccupation and anxiety scores during baseline, reality testing. verbal challenge and follow-up. anxiety) are shown in Figs 1-3. Figure 1 summarizes data from 6 individuals who received the verbal challenge first, 3 of whom went on to receive the reality testing second [for detailed sessional results see Chadwick and Lowe (1990)]. Figure 2 summarizes data for a further 4 individuals who all received the reality testing first and the verbal challenge second [see Chadwick and Lowe (in press) for details]. The two studies reported in Figs 1 and 2 used multiple-baseline designs across individuals. Figure 3 summarizes two single case studies, in both of which the verbal challenge was used in a multiple-baseline across delusions design to challenge three delusions; the three delusions were challenged successively at intervals of 4 or more weeks in the sequence of ordering used in Fig. 3 [for a full account, see Lowe and Chadwick (1990)]. Briefly, the delusions were as follows:
  • 73. BP believed that a woman, Amanda, was reading his mind and controlling his life, and that in past lives he had been Leonardo da Vinci and Jesus Christ; BG who was 51 years old, believed that she was only a teenager, that she was the daughter of Princess Anne, and that the Government was controlling her in elaborate and fantastic ways. Conviction Of the 12 participants, 10 (83%) reported reductions in their level of belief conviction as a consequence of the interventions, and 5 had rejected their delusions altogether by the close of the intervention period. In 10 cases conviction remained stable over baseline periods of between 4 and 10 weeks. Two individuals maintained their baseline levels of conviction throughout the interven- tion phases. For all individuals these changes were corroborated during assessment interviews with independent clinicians, and in 5 cases there was additional authentication from either a second professional or relative. The verbal challenge was a strong opening intervention. In the study depicted in Fig. 1, verbal challenge periods of &6 weeks provoked stable and large reductions in three (HM, TD & DR) of the 6 individuals and a substantial but transient reduction in a further person (EE). In spite of 360 P. D. J. CHADWICK and C. F. LOWE this, when reality testing followed the verbal challenge, in 2 out
  • 74. of 3 cases (EE & MM) it improved upon the effectiveness of the verbal challenge alone, suggesting that reality testing is a strong intervention when it follows the verbal challenge. Both individuals shown in Fig. 3 had rejected their three delusions by the close of the 14 sessions of verbal challenge. However, it should be noted that in the case of BP, an apparent generalization effect meant that conviction in the Leonardo belief had already fallen to only 10% by the time it was challenged. When reality testing was used as a first intervention over 224 weeks with 4 people (Fig. 2) only LJ showed a substantial drop in conviction, and this effect was transient with conviction returning to baseline level by the close of the reality testing period; her conviction fell again at the start of the verbal challenge period and this reduction was maintained. For the remaining 3 individuals, reality testing had little or no effect, although 2 (HJ & EE) showed a large fall in conviction during the subsequent verbal challenge period. For CE the verbal challenge, like reality testing, failed to alter conviction. Verbal challenge Follow-up y Fig. 3. Bar graph summarizing 2 individuals’ (BP & BG) weekly conviction, preoccupation and anxiety scores for each of their three delusions during baseline, verbal challenge and follow-up.
  • 75. Cognitive approach to delusions 361 Table I. BDI scores for all 12 participants at the final baseline session, the final intervention session and at the I-, 3-, and 6-month follow-ups (FU) Individual Baseline Intervention I-Month FU 3-Month FU 6- Month FU HM TD WH EE MM DR HJ LJ CE FD BP BG I9 35 I8 24 20 23 28 9 2s I3
  • 77. I6 I2 20 6 II 3 27 7 5 0 4 8 IO 8 9 24 8 On the basis of these results, reality testing on its own would seem to be a weak intervention, perhaps because strongly held beliefs are ‘immunized’ against disconfirming events (Popper, 1977). This finding gives preliminary empirical support to a hitherto untested assumption about CT, namely, that empirical testing is more effective when it follows a period of verbal challenge (e.g. Trower, Casey & Dryden, 1988). Preoccupation and anxiety At the close of every session we used personal questionnaire methods to extract a retrospective