Behavioural Activation for Bipolar Depression: A Case Series

Study Overview
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Brief Summary
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Bipolar Disorders affect around 2% of the population. Most people with Bipolar experience depression; these periods can cause difficulties with relationships, work and daily life. Psychological therapies for unipolar depression (for people who experience depression but never mania or hypomania) are widely available, but there is little research in to how effective these therapies are for people with Bipolar. Knowing this could give greater choice to people with Bipolar in terms of the therapy they have, and how easy it is to get within the NHS. One such therapy is called Behavioural Activation (BA). BA is an established therapy for people with unipolar depression. It helps people to re-establish healthier patterns of activity, but so far there is very little research into offering BA to people with BD. The current research involves a small number of people with Bipolar Depression receiving BA to see if it seems sensible and worthwhile to them, and to help us to make any necessary improvements to the therapy. The study is taking place in Devon and is sponsored by the University of Exeter. 12 people that are currently experiencing Bipolar Depression who choose to take part will receive up to 20 individual therapy sessions of BA that has been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews. The results of this study will not give the final answer on how effective BA is for people with bipolar depression, but will help to plan for a larger study that can answer this question.

Official Title
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Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation

Conditions
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Bipolar Depression

Intervention / Treatment
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* Other: Behavioural Activation (BA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a Structured Clinical Interview for Diagnosis (SCID-5) meeting diagnostic criteria for Bipolar I or II Disorder (SCID-5) participants will require working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need of a translator. Exclusion Criteria: current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise ability to use therapy current marked risk to self (i.e. self-harm or suicide) that we deem could not be appropriately managed in the AccEPT clinic at the Mood Disorders Centre currently lacking capacity to give informed consent currently receiving other psychosocial therapy for depression or bipolar disorder presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a case series using a multiple baseline design whereby participants are randomly allocated to one of 6 durations of wait at baseline before commencing treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 3 week wait<br>Participant waits for 3 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 4 week wait<br>Participant waits for 4 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 5 week wait<br>Participant waits for 5 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 6 week wait<br>Participant waits for 6 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 7 week wait<br>Participant waits for 7 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 8 week wait<br>Participant waits for 8 weeks after their baseline assessment before commencing therapy. | Other: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) | Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9) | through study completion, an average of 7 months | 
| No significant adverse reaction for participants | Participant reports of adverse events elicited by researchers and therapists. | through study completion, an average of 7 months | 
| Qualitative feedback from participants | Written and verbal feedback of participants | through study completion, an average of 7 months | 
| Qualitative feedback from therapists | Feedback given in qualitative interviews with therapists | through study completion, an average of 7 months | 
| Therapy uptake rate | Number of participants randomised who attend at least 1 treatment session | through study completion, an average of 7 months | 
| Therapy completion rate | Proportion of participants that attend at least 8 treatment sessions | through study completion, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altman Self-Rating Mania Scale (ASRM) | 5 item self-report measure of hypomania symptoms over the past week | 1 week | 
| Work and Social Adjustment Scale (WSAS) | 5 item self-report scale of functional impairment attributable to an identified problem | 24 hours | 
| Structured Clinical Interview for Depression (SCID) | Standardised interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence | Six months | 
| Hamilton Depression Scale (HAM-D) | 17 item observer-rated scale measuring symptoms of depression over the past week | 1 week | 
| Brief Quality of Life in Bipolar Disorder (Brief QoLBD) | 12 item self-report measure of disorder-specific quality of life | 1 week | 
| Bech-Rafaelsen Mania Scale | 11 item observer-rated scale measuring the severity of manic states | 1 week | 
| Beck Depression Inventory (BDI) | 21 item self-report measure of depressive symptoms and attitudes | 1 week | 
| General Anxiety Disorder Assessment - 7 (GAD7) | 7 item self-report measure of anxiety symptoms | 2 weeks | 
| Behavioral Activation for Depression Scale (BADS) | 25 item self-report measure of changes in activation and avoidance over the past week | 1 week | 
| Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) | 7-item self-report measure of wellbeing | 2 weeks | 
| Snaith-Hamilton Pleasure Scale (SHAPS) | 14 item self-report measure of level of anhedonia | 1 week | 
| Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale | 14 and 12 items respectively, these self-report scales measure tendency to respond impulsively to positive or negative feelings | 6 months | 
| Questions about Suffering, Struggling and Engagement in Valued Activities | 3 item self-report measure of core hypothesised process of change in behavioural activation, namely reduction in avoidance behaviours and increase in rewarding behaviours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural Activation, Bipolar Disorder, Bipolar Depression, Multiple Baseline, Case Series