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Lessons Learnt in Trial Development 
and Implementation 
Steven Jones
CBT for Anxiety Recovery CBT 
Individual 
Interventions 
for early BD 
Recovery CBT for 
established BD 
MI-CBT for 
alcohol in BD 
Group 
Interventions 
Family 
intervention 
REACT trial 
Psycho- CA REACT 
education vs 
peer support 
IBPI study ERP 
Online 
Interventions 
Triple P pilot 
Living with BD
• In a recent survey of 9000 people with a bipolar 
diagnosis. 
• 92% has at least one other comorbid diagnosis 
• Main ones highlighted 
• Anxiety 
• Alcohol/substance use 
• Impulse control disorders (attention, behaviour 
or anger problems) 
• Merikangas et al., 2007
• 93% of people with a bipolar diagnosis have lifetime experience of 
anxiety. 
• 32% of people have current anxiety difficulties 
• Co-morbid anxiety and bipolar are associated with 
– poor treatment response 
– increased suicidality 
– earlier age of onset 
– greater risk of relapse 
• Effective interventions exist for anxiety and bipolar separately. 
• No definitive research into psychological treatment of bipolar and 
anxiety together. 
McIntyre, et al., 2006 
Otto et al., 2006 
Feske, et al., 2000 
Frank, et al., 2002 
Henry, et al., 2003 
Ouimet et al, 2009
The following slides present independent research commissioned by the National Institute for 
Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG- 
0407-10389). Further support was received from primary care trusts, mental health trusts, 
the Mental Health Research Network and Comprehensive Local Research Networks in North 
West England. 
The views expressed in this publication are those of the authors and not necessarily those of the 
NHS, the NIHR or the Department of Health.
• Most therapy approaches split anxiety and BD. 
• Common therapist question – which do we treat first? 
• People’s lived experience however integrates both. 
• “I think the thing to do would be to find out why I 
become so anxious, unreasonably so over little things 
and why I would get so anxious that ...I would do 
something as dramatic as abandon my son, jump in my 
car and drive away. Why would that be a good idea? but 
that is driven seriously by anxiety”
• Informed by evidence-based CBT for 
anxiety & bipolar 
• 10 therapy sessions over 4 months 
• Delivered by BABCP accredited therapists 
• Therapy individualised and formulation 
driven
• Recruitment = 72 participants (37 intervention/35 
control). 
• Bipolar disorder & anxiety (HADS 8+) 
• 18+ 
• English speaking 
• No episode in the past 4 weeks 
• No current suicidal intent 
• Not taking part in any other intervention study
• Better able to control BD 
• Change views of BD – averting relapse 
• Anxiety improved – better coping skills 
• Reduced medication 
• Changes to lifestyle and behaviour 
• Feel like a better person!
• Integrating service user views into 
development of therapy led to more 
individualised therapy 
• Consequence – good recruitment and 
retention 
• General positive experiences of therapy 
process and structure - 
– NB not everyone some felt a bit rushed 
• Next step definitive trial – hopefully
• Contact Steve Jones – 
s.jones7@lancaster.ac.uk
Clinical Outcomes 
• Primary clinical outcomes 
• Anxiety symptoms - HAM-AD and STAI 
• Time to relapses of mood episodes as 
measured by SCID-LIFE 
• Mood symptoms - HAM-AD and MAS 
• Analysis to take place in next few weeks!

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Steven Jones | Anxiety Intervention

  • 1. Lessons Learnt in Trial Development and Implementation Steven Jones
  • 2. CBT for Anxiety Recovery CBT Individual Interventions for early BD Recovery CBT for established BD MI-CBT for alcohol in BD Group Interventions Family intervention REACT trial Psycho- CA REACT education vs peer support IBPI study ERP Online Interventions Triple P pilot Living with BD
  • 3. • In a recent survey of 9000 people with a bipolar diagnosis. • 92% has at least one other comorbid diagnosis • Main ones highlighted • Anxiety • Alcohol/substance use • Impulse control disorders (attention, behaviour or anger problems) • Merikangas et al., 2007
  • 4. • 93% of people with a bipolar diagnosis have lifetime experience of anxiety. • 32% of people have current anxiety difficulties • Co-morbid anxiety and bipolar are associated with – poor treatment response – increased suicidality – earlier age of onset – greater risk of relapse • Effective interventions exist for anxiety and bipolar separately. • No definitive research into psychological treatment of bipolar and anxiety together. McIntyre, et al., 2006 Otto et al., 2006 Feske, et al., 2000 Frank, et al., 2002 Henry, et al., 2003 Ouimet et al, 2009
  • 5. The following slides present independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG- 0407-10389). Further support was received from primary care trusts, mental health trusts, the Mental Health Research Network and Comprehensive Local Research Networks in North West England. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
  • 6. • Most therapy approaches split anxiety and BD. • Common therapist question – which do we treat first? • People’s lived experience however integrates both. • “I think the thing to do would be to find out why I become so anxious, unreasonably so over little things and why I would get so anxious that ...I would do something as dramatic as abandon my son, jump in my car and drive away. Why would that be a good idea? but that is driven seriously by anxiety”
  • 7. • Informed by evidence-based CBT for anxiety & bipolar • 10 therapy sessions over 4 months • Delivered by BABCP accredited therapists • Therapy individualised and formulation driven
  • 8. • Recruitment = 72 participants (37 intervention/35 control). • Bipolar disorder & anxiety (HADS 8+) • 18+ • English speaking • No episode in the past 4 weeks • No current suicidal intent • Not taking part in any other intervention study
  • 9.
  • 10. • Better able to control BD • Change views of BD – averting relapse • Anxiety improved – better coping skills • Reduced medication • Changes to lifestyle and behaviour • Feel like a better person!
  • 11. • Integrating service user views into development of therapy led to more individualised therapy • Consequence – good recruitment and retention • General positive experiences of therapy process and structure - – NB not everyone some felt a bit rushed • Next step definitive trial – hopefully
  • 12. • Contact Steve Jones – s.jones7@lancaster.ac.uk
  • 13. Clinical Outcomes • Primary clinical outcomes • Anxiety symptoms - HAM-AD and STAI • Time to relapses of mood episodes as measured by SCID-LIFE • Mood symptoms - HAM-AD and MAS • Analysis to take place in next few weeks!

Editor's Notes

  1. Slides now updated to reflect the n=53 fups done that there was discrepancy with on anxiety database – so final fup figure is 76% (reducing n of 72 to 70 for the 2 deaths – both in CBT arm – 1 cancer, 1 unknown cause). Both deaths occurred between 16 m and 20m due date