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Archives of Psychiatric Nursing 30 (2016) 322–328
Contents lists available at ScienceDirect
Archives of Psychiatric Nursing
journal homepage: www.elsevier.com/locate/apnu
The Effect of a Drug Adherence Enhancement Program on the
Drug
Adherence Behaviors of Patients With Major Depressive

Disorder in
Thailand: A Randomized Clinical Trial
Usa Vannachavee a, Acharaporn Seeherunwong b,⁎ , Prapa
Yuttatri b, Sudsabuy Chulakadabba a
a Faculty of Medicine Siriraj Hospital, Mahidol University,
Bangkok, Thailand
b Faculty of Nursing, Mahidol University, Bangkok, Thailand
a b s t r a c t
This study aimed to compare drug adherence behaviors during
the sixth week between patients with first
diagnosed major depressive disorder who received the Drug
Adherence Enhancement Program and those who
received only the usual care. A randomized clinical trial, post-
test only design was conducted in the
outpatient-unit of a medical school hospital in Bangkok,
Thailand. The experimental and control groups consisted
of 30 and 26 participants respectively. Participants in the
experimental group exhibited significantly higher drug
adherence behaviors than the control group. This is important
for nurses in promoting adherence to antidepressant
drugs for patients with first diagnosed major depressive
disorder.
© 2015 Elsevier Inc. All rights reserved.
Patients with major depressive disorder (MDD) can have their
depressive symptoms relieved by taking antidepressant drugs
continu-
ously according to a treatment protocol. Clinical practice
guidelines
strongly recommend using antidepressant medication as an
initial
modality for at least 6–12 weeks to induce remission of
symptoms
during the acute phase of treatment (American Psychiatric

Association,
2010). However, patients with MDD tend to be uncooperative
regarding
medication intake when antidepressant drugs are first
prescribed. Study
findings have revealed that the lack of cooperation of patients
with
MDD is commonly found within the first three months of
treatment
(Nemeroff, 2003), and about 70% of patients with MDD
discontinue
their medications by themselves during the course of treatment
(Demyttenaere et al., 2008; Haynes, Ackloo, Sahota, McDonald,
& Yao,
2008; Pampallona, Bollini, Tibaldi, Kupelnick, & Munizza,
2002). Of
Thai patients with MDD who sought treatment at a medical
school
hospital as many as 64% did not follow up on treatment within
the
first month (Vannachavee, Pakdeejit, & Seeherunwong, 2008).
On
the other hand, approximately four out of 10 US patients
(42.4%) who
initiated antidepressant treatment for depression discontinued
their
antidepressant medication during the first 30 days of treatment.
⁎ Corresponding Author: Acharaporn Seeherunwong, DNS, RN,
Associate Professor, Faculty
of Nursing, Mahidol University, 2 Phannok road, Bangkoknoi,
Bangkok, Thailand 10700.
E-mail addresses: [email protected] (U. Vannachavee),
[email protected] (A. Seeherunwong), [email protected] (P.
Yuttatri),
[email protected] (S. Chulakadabba).

http://dx.doi.org/10.1016/j.apnu.2015.12.001
0883-9417/© 2015 Elsevier Inc. All rights reserved.
BACKGROUND
There are many reasons for drug non-adherence during the first
diagnosis of MDD. The major reasons are erroneous beliefs
about the disease
and its pharmacological treatment. The other reasons are
physical and
mental suffering from the adverse drug effect occurring after
their use
(Bollini, Pampallona, Kupelnick, Tibaldi, & Munizza, 2006;
Chakraborty,
Avasthi, Kumar, & Grover, 2008; Demyttenaere, 2001; Nabeel,
2008).
People who have been diagnosed with MDD have perceived that
they
were insane and could not accept their abilities as a normal
person
(Seeherunwong, Boontong, Sindthu, & Nilchaikovit, 2002). As a
result,
they refused and neglected taking medication because it is a
symbol of
having mental illness (Sirey et al., 2001). Regarding the
treatment,
patients believed that medication cannot solve their mental
sufferings,
and assume that continuous medication intake will make them
become
dependent on antidepressant drugs for the rest of their lives
(Aikens, Nease, & Klinkman, 2008). Patients also incorrectly
think that
antidepressant drugs are like symptomatic treatment that should
be
discontinued when the symptoms are lessened or should be

taken only
when they have the symptoms (Chakraborty et al., 2008).
Regarding
drug adverse reactions, patients were unable to tolerate the
undesirable
reactions of the drugs such as dizziness and drowsiness, which
are most
likely to occur in the early course of treatment (Lin, Korff, &
Katon,
1995; Maddox, Levi, & Thompson, 1994). Furthermore, during
delivery
services in an outpatient clinic, health care providers did not
have enough
time to create a relationship and provide individualized
information to
the patients, which led to the patients' continued
misunderstanding and
erroneous beliefs. All of these reasons cause patients to
terminate their
medication in the early days of treatment.
http://crossmark.crossref.org/dialog/?doi=10.1016/j.apnu.2015.1
2.001&domain=pdf
mailto:[email protected]
http://www.sciencedirect.com/science/journal/
Table 1
Topic and Implementation of Each Session of the DAEP.
Session Implementation

#1 Motivation to comply with
the treatment plans
Build the nurse–patient relationship and conduct comprehensive
assessment for understanding the patient's problems and care
needs
Find out the participant's goal for visiting psychiatry clinic
Explore patient's attitude, perceptions, and feelings toward
depressive disorder and its impact
Find out the patient's erroneous attitudes toward becoming a
patient with depressive disorder and its treatment
Provide information about MDD and its treatment
Encourage participants to present their concerns and intention
to adhere to the regime
Use trigger questioning to make the patients aware of their
problems, provide information or useful options for making
decisions regarding
self-care and to perceive the situation as manageable, leading
them to have hope, set goals, and make plans for their mental
health
Assign homework to record drug taking on worksheet every day
#2 Enhancement of confidence and
strengthening the commitment
to take medication
Explore the experience of medication taking, its benefit, and
barriers to adhering to drug taking
Search for feelings of ambivalence toward drug use
Elicit attitudes, perceptions, and feelings about drug taking that
made the patients have ambivalence concerning adherence
Modify erroneous automatic thought toward drug taking,
symptoms of adverse effects, and their illness
Provide information tailored to the patient regarding the illness,
reasons for using antidepressant drugs, and how to manage

adverse effects
Modify their behaviors that did not facilitate drug taking or
recovery
Record a plan to change specific behavior
Assign homework to make them have a sense of success
#3 Monitoring and evaluation
of the actual situation
Help the patients manage problems related to adverse effects of
drugs and other problems
Anchor drug adherence
Assign homework to record change in perceptions and feelings
in the worksheet
#4 Planning for continuing
adherence
Prepare for solutions to drug taking problems for a long time
Rehearse alternative options when forgetting to take drugs
Provide information related to problems in discontinuing the
regimen
Encourage continuous medication intake after the end of the
program
Revision and summarization
323U. Vannachavee et al. / Archives of Psychiatric Nursing 30
(2016) 322–328
A program that can enhance patients' cooperation in the
treatment
of MDD, increase their medication adherence, and reduce their
depres-
sive symptoms has been developed based on the concept of
motivational
interviewing of Miller and Rollnick (2002), together with the
strategies of the cognitive therapy of Beck, Rush, Shaw, and

Emery
(1979). It has been reported that such a program is effective in
adjusting
patients' attitudes toward medication intake (Tay, 2007) and
their
motivation to continue drug taking to 12 weeks is 2.7 times that
of
those who received the usual care (OR 2.7, 95% CI 1.6–4.8),
resulting
in significantly improvement in depressive symptoms during the
follow-ups at 12 weeks (Peveler, George, Kinmonth, Campbell,
&
Thompson, 1999) and six months after the medication treatment
(Sirey et al., 2001). In Thai psychiatric clinics, there is no
nursing inter-
vention to improve the drug adherence of patients with MDD.
There-
fore, the researcher developed the Drug Adherence
Enhancement
Program (DAEP) based on the concept of motivational
interviewing
(MI) proposed by Miller and Rollnick (2002), implemented
together
with the concept of cognitive therapy of Beck et al. (1979). The
DAEP
was utilized for patients with first episodes of MDD who were
still
receiving pharmacological treatment for the first time.
According to
MI, the program provides counseling which emphasizes to the
patients
the problems caused to them by non-adherence and manages
their hes-
itation in becoming motivated to take antidepressant drugs.
Regarding
the cognitive approach, the program placed its emphasis on

negative
automatic thinking and erroneous beliefs associated with the
disease
and its treatment, which directly affected patients' motivation
and
hesitation in appropriately adhering to the treatment plan and
taking
antidepressant drugs. In addition, the DAEP emphasized the
establishment of a good relationship between nurses and
patients,
encouraged patients to accept their illness and treatment with
medica-
tions, reduced their anxiety and concern about the undesirable
side
effects of the prescribed antidepressant drugs, and provided
informa-
tion regarding the benefits of antidepressant drugs. Therefore,
the
specific aim of the current study was to determine the effect of
the
DAEP on the drug adherence behaviors of patients with MDD.
The secondary aim was to explore the lessons learned from the
clinical
implementation. We hypothesized that patients with MDD who
received the DAEP together with usual care would exhibit better
drug
adherence behaviors during the sixth week after the initial
treatment
than those who received only the usual care.
METHODS
Design
A randomized controlled trial with two parallel-group posttest-
only
designs was used in this study. As a result of the patients

visiting the
clinic for the first time, there was no pre-test score for drug
adherence
behavior. The study was carried out from October 2009 to
January
2010. The experimental group received the DAEP for four
weeks plus
the usual care, while the control group only received the usual
care.
Sample and Setting
The target population was outpatients first diagnosed with MDD
at
the psychiatric unit of a medical school hospital, in Bangkok,
Thailand.
The patients were recruited based on the inclusion criteria as
follows:
1) male or female patients aged 18 or over, 2) receiving a first
diagnosis
of MDD based on the DSM-IV TR criteria by psychiatrist, 3)
starting
treatment with antidepressant drugs, 4) Thai language ability
and
5) no psychosis. The participants who met the inclusion criteria
and
who were willing to participate in the study were randomly
assigned
into the experimental group and the control group, with 30
participants
in each group, using block randomization performed using a
statistical
computer program. Participants were excluded if they had any
addi-
tional psychotic symptoms and/or had attempted suicide.
Sample sizes were calculated on the basis of medium effect size

(ES = 0.5) of the intervention on the outcome of the drug
adherence
(Cohen, 1988), using a one-sided 5% significance level. The
sample
sizes are sufficient to have about 90% power to detect a
difference
between experimental and control groups of 30 in t-test
analysis.
The hospital where this study took place is a leading medical
school.
The hospital provides general tertiary health care services
having 1200
beds for inpatients. Bangkok is the capital of Thailand, and a
major
commercial city, with a population of 10,000,000 and an
estimated
MDD prevalence of 3.2% in males and 4.8 in females aged over
15
(data from national survey of Department of Mental Health,
Ministry
of Public Health, Thailand 2008). From the monthly record of
the
psychiatric unit, the number of new patients with first episode
MDD
averages 29 per month.
324 U. Vannachavee et al. / Archives of Psychiatric Nursing 30
(2016) 322–328
Drug Adherence Enhancement Program
The DAEP was developed by the researchers and comprises four
individual face-to-face sessions that take place over a 4-week
period.

The program integrated three main components: an educational
component imparting information about depressive disorders
and their
treatment; (2) a motivational component; and (3) a cognitive
compo-
nent. The contents of the program covered the initiation of
motivation
to adhere to the treatment plan, solving the patients' problems,
negative
automatic thoughts, and erroneous beliefs, and overcoming
obstacles
during medication intake to strengthen the patients' motivation
to adhere
continuously to medication intake. The topics and
implementation of the
four sessions are shown in Table 1. The first session took 1
hour, and the
second through fourth sessions were approximately 30–45
minutes
in length.
During the implementation of the program, worksheets designed
by
the researchers were used to record the participants'
information,
which was provided in response to trigger questions for the
creation
of motivation, such as the reasons for coming to see the doctor,
the
levels of motivation regarding medication intake, problems and
obstacles with medication intake, the reasons for medication
intake,
etc. The level of motivation was arranged on a ruler scale,
which is a
simple form of measurement. The participants were asked to
evaluate

their motivation and encouraged to talk about drug taking “How
strong
do you feel about wanting to take drugs?” on a scale from 1 to
10, where
1 was “not at all” and 10 was “very much.” The patient was
asked,
“Where would you place yourself now?” For instance, the
patient was
asked why he or she gave a particular number, say 5, and not a
lower
number. This conversation was explored in some detail. During
sessions
1–4 the researcher provided written tasks for that session, and
in the
follow-up session the researcher kept a record of all of the
patient contacts.
In addition to the worksheets, the participants received a
booklet
comprising knowledge on dealing with the adverse effects of
medication and a self-reported medication intake form created
by
the researchers.
A candidate master degree researcher conducted the
intervention
using a comprehensive program manual developed by the
researchers.
The program manual was examined by a panel of five experts,
including
two psychiatrists, two psychiatric nursing instructors, and one
highly-
experienced professional nurse, to ensure content validity and
language
appropriateness.

Measurement
The General Information Questionnaire was designed to collect
the demographic data and clinical information, including
gender, age,
marital status, educational background, occupation, and
antidepressant
drugs prescribed.
Montgomery–Asberg Depression Rating Scale (MADRS)
The MADRS is a ten-item observer-rated scale (1979) and was
translated into Thai by Thitakawee Kaewpornsawan (Sathapisit,
Posya-anuwat, Sasalaksananon, Kaewpornsawan, & Singhakan,
2007).
The MADRS was used to assess the severity of depressive
symptoms
on a 0–6 severity scale, resulting in a total score range of 0–60.
The va-
lidity and reliability of the MADRS Thai-version were at a high
level,
with the inter-rater reliability and intra-rater reliability equal to
.99
and .99, respectively (Sathapisit et al., 2007). MADRS provides
informa-
tion on depression, internal tension, reduced sleeping, reduced
appetite,
difficulty concentrating, fatigue, inability to have feelings,
negative
thinking, and suicidal thoughts. Scores equal to or higher than
21 points
meant that the patients were depressed.
Self-Medication Intake Record Form (SMIR)
Drug adherence behaviors were measured using the SMIR
devel-

oped by the researchers based on the concept that drug
adherence
behaviors can be assessed according to the number of days that
the
patients correctly take medication, with the right dose and at the
right
time (Demyttenaere, 1997). This should be followed up
continuously
for more than one month. In this study, a self-report daily
medication
intake form was designed with three response choices: complete
as pre-
scribed by the doctor, score = 1; incomplete medication intake,
score = 0; and no medication intake at all, score = 0. The total
scores
were calculated from the patients' self-report lasting six weeks
(42 days) to determine their drug adherence behaviors. The
record
form was determined to be valid in previous research, and it
yields sim-
ilar results to the medication event monitor system (MEMS)
(Ludman
et al., 2003; Peveler et al., 1999). The self-reported number of
days
that the patients took medication in one month was highly
correlated
with the data from the MEMS with 86.7% agreement and K =
0.66
(Ludman et al., 2003). The record form was submitted to a panel
of ex-
perts to ensure its content validity and was revised based on
their sug-
gestions. The record form was tried out with five participants
whose
demographic characteristics were similar to those of the

participants
in the main study to ensure clarity and ease of understanding.
Ethical Considerations
This study was approved by the Medical School's Ethical
Committee
for the protection of human subjects, code number Si476/2009.
A com-
plete description of the study was provided to the patients and
written
informed consent was obtained from each one. The participants
were
informed that they could withdraw at any time without effect on
their
health service from the clinic. They were also informed that all
of the in-
formation gathered in the study would be treated as
confidential.
Data Collection
The evaluation of the program took place two weeks after the
last
session. The program was used with newly-diagnosed patients
when
they were first admitted to treatment. The participants of the
control
group received the usual care from the nurses. When the
participants
finished their first visit to a psychiatrist in the outpatient clinic,
nurses
provided them with health education on MDD, offered advice on
keep-
ing up with their follow-up appointments, and made telephone
follow-

ups if the participants did not show up on the appointment day.
In gen-
eral, the psychiatrist made an appointment for a follow-up
examination
every one or two weeks, for a total of four appointments. When
the pa-
tients' symptoms had improved, the intervals between the
follow-ups
were extended. In this study, one of the researchers met each
partici-
pant in the control group twice, at six-week intervals. During
the first
session, the researcher collected information on patients'
demographic
characteristics and severity of depressive symptoms from their
first di-
agnosis with MDD and pharmacological treatment via
interviewing.
The researcher also gave them a manual for patients with MDD
which
included the SMIR for keeping a daily record of their
medication intake
at home for a period of six weeks. During the second session, at
the sixth
week of treatment, the researcher assessed their depressive
symptoms
and collected the SMIR during the follow-up appointment. At
the end
of the research procedure, it was found that there were four
participants
who did not show up on the appointment days and these
participants
could not be reached. Therefore, they were excluded from the
study,
and the total number of participants in the control group was
then re-

duced to 26.
The participants in the experimental group received routine
nursing
care similar to that of the participants in the control group.
However,
they also received the DAEP for a total of four sessions, each
lasting
30–60 minutes. The first session was conducted when the
participants
first attended the clinic with the initial received antidepressant
treatment, and the second to fourth sessions were conducted
when
the participants came to visit the psychiatrist on the days of the
appointment. The researcher conducted the intervention after
the
Randomly assigned
approached
60 participants received
baseline assessment
Experimental group:
n=30
Control group: n=30
7 re-arranged their
appointment

2 re-arranged their
appointment
4 lost to follow-up
30 participants
completed the study
Post-test Post-test
2 wks
2 wks
DAEP
4 wks
4 wks
26 participants completed
the study
60 potential participants were
Fig. 1. Recruitment and retention patterns of participants.
325U. Vannachavee et al. / Archives of Psychiatric Nursing 30
(2016) 322–328
psychiatrists had finished the examination of the participants.
The
researcher asked the participants if it was convenient for them
to
participate in the rest of the sessions on the day that was
planned or if
they would rather choose the days on which they were available,
which

could be the days of the follow-up appointment. The researcher
offered
the participants 200 baht (35 THB = 1 $US) for their traveling
expenses.
After the research ended, it was found that all of the
experiment's
participants cooperated with the research procedure and all 30
participants remained in the program until the end (Fig. 1).
Data Analysis
Chi-square or Fisher's exact test was used to compare the
character-
istics of the experimental and control groups and an
independent t-test
was utilized to compare age and depressive symptoms. The
indepen-
dent t-test was employed to examine the mean difference in
drug
adherence behaviors after the intervention with both groups.
The
significance level was set at 0.05. Data analysis was carried out
using
IBM SPSS Statistics, version 17. Moreover, the written
statements on
the experimental group worksheets from the second and third
sessions
of the intervention were analyzed using content analysis.
RESULTS
Participants
The participants in the experimental and control groups were
not different in terms of statistical significance, except for
occupation.
A further analysis revealed that most of the participants in the
control

group were unemployed, while the largest group of participants
in the
experimental group consisted of government officials. The mean
scores
on the depressive symptoms at baseline were not different but a
difference was found between both groups at two weeks after
the intervention (Table 2).
Effect of Intervention on Drug Adherence Behaviors
The participants in the experimental group who received the
usual
care together with the DAEP had a higher mean score on drug
adher-
ence behaviors during the sixth week than that of the
participants in
the control group, who received only the usual care, with
statistical sig-
nificance (Table 3). In addition, the three highest barriers to
taking anti-
depressant drugs during the second week of participations in the
experimental group included drug adverse effects (33%), the
beliefs
that drugs cannot relieve mental distress (21%), and concern
about
the danger of taking drugs (10%) (Table 4). After participating
in the sec-
ond session of the intervention, during the third week they
reported their
reasons for continuing to take drugs, including getting better
after taking
them (40%), no longer suffering from the side effects of the
drugs (20%),
and making the decision to complete the treatment plan (20%)
(Table 5).
DISCUSSION

The participants in the experimental group had more correct
drug
adherence behaviors in terms of the dosage and timing when
compared
to those in the control group with statistical significance. Thus,
the study
hypothesis was accepted. This evidenced that a multi-facetted
compo-
nents program based on the integration of the strategies of
motivational
interviewing and cognitive therapy tailored to meet the needs of
Thai
patients with MDD can improve drug adherence behaviors. It
reinforced
a finding from a recent systematic review (Nieuwlaat et al.,
2014). As a
result, patients' needs were met as soon as they first came to
seek treat-
ment, which continued all through the subsequent follow-ups at
the
outpatient-clinic. The finding was consistent with previous
studies
that reported that collaborative intervention between health care
providers and patients tailoring the information and the methods
of
communication, in response to the problems reported by the
patient
at the initial time of treatment could enhance drug adherence
and
attendance at subsequent appointments. A study of Olfson,
Marcus,
Tedeschi, and Wan (2006) found that patients who received

Table 2
Group Differences on Demographic Characteristics and Clinical
Symptoms of Participants.
Variables Experimental
(n = 30)
Control
(n = 26)
p-value
n (%) n (%)
Gendera .815ns
Male 4 13 5 19
Female 26 87 21 81
Agea .619ns
b25 years 3 10 4 15
25–44 years 12 40 7 27
45–59 years 11 37 9 35
N60 years 4 13 6 23
Ageb 44.07 14.15 45.92 17.47 .439ns
Marital statusa .062ns
Single 9 30 10 39
Married 17 57 13 50
Separated/divorced/widowed 4 13 3 11
Education levela .637ns

No formal education 1 3 2 8
Primary education 8 27 5 19
Secondary education 2 7 5 19
Certificate of vocational Education 3 10 1 4
Under graduate education 13 43 11 42
Graduate education 3 10 2 8
Occupationa .035
Housework/unemployed 7 23 16 62
Government official 10 33 1 4
Agriculture 2 7 2 8
Own business 2 7 2 8
Employed 8 27 4 14
Student 1 3 1 4
Antidepressant drugs receiveda .904ns
MAOI – – – –
TCA 3 10 2 8
SSRI 24 80 22 84
Others 3 10 2 8
Depressive symptoms [Mean (SD)]b
Pre-test 28.01 6.82 25.73 6.83 1.29ns
Post-test 11.53 6.59 19.90 11.07 .004⁎
ns = no statistical significance, p N .05
⁎ p-value ≤0.05 level was considered statistically significant.
a Chi-square or Fisher's exact test was used.
b Independent sample t-test was used.
326 U. Vannachavee et al. / Archives of Psychiatric Nursing 30
(2016) 322–328
psychotherapy or mental health counseling during the initial

period
of antidepressant treatment were significantly more likely to
continue
antidepressants beyond 30 days than those who did not receive
psycho-
therapy (64.8% versus 43.7%). A study by Peveler et al. (1999)
revealed
that drug counseling by a nurse at weeks 2 and 8 according to a
written
protocol had a significant effect on adherence self-reported at 6
weeks
and 12 weeks than receiving a leaflet. Regarding the counseling,
the nurses assessed the patients' attitudes toward treatment,
under-
standing of medication intake and provided knowledge about
depressive illness and related problems, the importance of
medication
intake, and side effects and their management. Similarly,
Hunkeler,
Mersman, Hargreaves, and Fireman (2000) found that when
nurses
showed compassion and understanding and offered to help solve
the
patients' problems with medication intake and psychosocial
problems
through consistent telephone calls during the first six weeks of
the
Table 3
Effect of the DAEP on Drug Adherence Behaviors During the
Sixth Week.
Drug adherence behaviors Experimental
group (n = 30)
Con
(n =

Mean SD Mea
Total drug adherence scores at six weeks (42 days) 41.17 2.87
22.5
⁎ Significance at p b .05
† Significance at p b .05
treatment, the patients with MDD had more satisfaction with the
treatment. Also, 10 minutes of drug-related counseling by a
pharmacist
for the patients increased attendance at scheduled follow up
clinics
6 weeks after initial treatment (66%) more than the group
receiving
leaflets (58%) and the 34% of the control group, which is a
statistically
significant difference (p = 0.004). After adjusting for age, sex
and
education, counseling was significa ntly associated with a much
higher
incidence of using medication correctly (OR 31.3, p = 0.009),
leaflet
use was less strongly associated (OR 8.4, p = 0.009) (Nabeel,
2008).
On the other hand, it was supported by previous studies that
found
that information alone provided by leaflet (Peveler et al., 1999)
or
repeated mailings (Mundt, Clarke, Burroughs, Brenneman, &
Griest,
2001) were not enough to enhance medication adherence.
Regarding clinical benefits, the findings showed that the
patients
who received the DAEP had better depression scores after the

interven-
tion than those who received only the usual care at a significant
level, as
shown in Table 1. This information supported the finding that
the DAEP
could enhance patients' drug adherence behaviors. As the
antidepres-
sant drugs adjusted the balance of the biochemical substances in
the
brain, patients' depressive symptoms improved. However, the
depres-
sion scores of the participants in the control group also reduced
during
the sixth week of the intervention, but to a lesser extent when
com-
pared to the scores of the participants in the intervention group.
One
plausible explanation is that the participants in the control
group did
not have correct or consistent medication intake. According to
the
interviews, some participants indicated that they took only
sleeping
pills but did not take the …
Ethical Considerations in Mental Health Research Paper
Each student will be assigned one of three faculty selected
articles and will write a three to four page paper addressing
ethical issues related to protection of a vulnerable
3. Vannachavee, U., Seeherunwong, A, Yuttatri, P., &
Chulakadabba, S. (2016). The effect of a
drug adherence enhancement program on the drug
adherence behaviors of patients
with major depressive disorder in Thailand: A

randomized clinical trial. Archives of
Psychiatric Nursing, 30, 322-328.
*Keep in mind that you will need to include at least two other
references to support your opinion. These references must be
from a reliable and professional source.
Imagine that you are a member of a human subjects review
committee or the institutional review board and are considering
whether to approve this study. You job is to evaluate whether
the ethical rights of the potential subjects were protected.
While the study has already been completed and published, and
results are available, do not consider the results as you analyze
the ethics of the study. Focus your evaluation on the plans to
protect the vulnerable population. You will need to support
your argument with other published scholarly work.
Questions you may want to consider are as follows:
· Consider if the subjects or their proxy gave voluntary and
informed consent. Many studies are not specific about this, but
you should decide what the researchers should have done based
upon the diagnosis, mental health issues, cultural, and other
considerations of the group of patients being studied and the
research (medication, psychotherapy, diagnostic testing,
personality testing, etc.). If a proxy was used, was their
sufficient reason for using a proxy, and did the subject give his
or her own view or assent?
· Evaluate if the study was worthwhile doing.
· Evaluate the risk/ benefit ratio. Were the possible benefits of
the study sufficient to justify the risks to the subjects? Were the
risks so great that the subjects should not have been asked to
participate, or should have said no to participating?
Were there adequate protections in place for the subjects? If
there was a wash out phase, or placebos, were the subjects
protected? Did the subjects have psychiatric and medical
evaluations sufficiently frequently and in enough depth for the
researchers to protect them from harm?

- All of the above topics may not be specifically addressed in
the article, and it is the student’s assignment to think about this
study and read relevant articles that discuss the above issues
and come to your own conclusions.
- Sources must be cited for any ideas taken from authors; even
if they are stated in your own words. The paper should be no
more than 4 pages of text in length (not counting title page and
references) and should be written in A.P.A. format.
Students should only write one paragraph to summarize the
study and assume that the reader has read the study.
- The purpose is not to evaluate the results of the study, but the
ethical aspects of doing the study.
-The paper must be succinct and well written. This includes
being well organized, having clear expression of ideas and
opinions as well as proper mechanics (spelling, punctuation,
references, grammar, etc.).
-The ethical issues selected must be explored in depth and
should address the topics listed above that are relevant for that
study.

Ethics Paper Rubric
Criteria
Ratings
Points Points
Brief summary of the study a. Logical and clear writing
10.0 pts
Exceeds Standard/Very Good/Outstanding 9-10 points
8.0 pts
Meets Standard/Good 7-8 points
6.0 pts
Below Standard 0-6 points
10.0 pts
Student's discussion with development of argument to address
the following if applicable (weighting change applied if not
applicable) a. Discussion of voluntary and informed consent
including IRB approval, written consent, and written assent
10.0 pts
8.0 pts

6.0 pts
10.0 pts
Student’s discussion with development of argument to address
applicable) b. Evaluation of inherent worth of the study
including contribution to body of knowledge and additional
adherent benefits
10.0 pts
8.0 pts
6.0 pts
10.0 pts
applicable)
Student's own opinion with rational development of argument
with
discussion of the following if applicable (weighting change
applied if not applicable)
c. Evaluation of the risk/benefit ratio including risks and
benefits of study and comparison of risks versus benefits.
10.0 pts

8.0 pts
6.0 pts
10.0 pts
applicable) d. Evaluation of adequate protections for subjects
including protections
10.0 pts
8.0 pts
6.0 pts
10.0 pts
applicable) e. Evaluation of inclusion and exclusion criteria,
evaluation of overall sample selection, and additional concerns
for protections for subjects based upon diagnosis or other
criteria (age, gender, culture, etc.)
10.0 pts
8.0 pts

6.0 pts
10.0 pts
applicable) f. Logical and clear writing
10.0 pts
8.0 pts
6.0 pts
10.0 pts
Student’s argument supported with literature
20.0 pts
16.0 pts
13.0 pts
20.0 pts
Format of Paper a. APA Style b. Spelling, grammar, and

punctuation c. In-text citations and reference list (at least 2
references)
10.0 pts
8.0 pts
6.0 pts
10.0 pts
10.0 pts
8.0 pts
6.0 pts
10.0 pts
Total Points: 100.0
Order #214565173 Ethical Considerations in Mental Health
Research Paper (3 pages, 0 slides)
Type of service:
Writing from scratch
Work type:

Research paper
Deadline:
(15h)
Academic level:
College (3-4 years: Junior, Senior)
Subject or Discipline:
Health Care
Title:
Ethical Considerations in Mental Health Research Paper
Number of sources:
3
Provide digital sources used:
No
Paper format:
APA
# of pages:
3
Spacing:
Double spaced
# of words:
825
# of slides:
ppt icon 0
# of charts:
0
Paper details:
Kindly see attached document for instruction, article and
grading criteria
Comments:

Customer local details
01:02 AM, United States of America
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