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

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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Depression
• Intervention / Treatment: Other: Behavioural Activation (BA)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Exeter, United Kingdom, EX4 4QG
    • University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 3 week wait; Participant waits for 3 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.
OTHER: 4 week wait; Participant waits for 4 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.
OTHER: 5 week wait; Participant waits for 5 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.
OTHER: 6 week wait; Participant waits for 6 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.
OTHER: 7 week wait; Participant waits for 7 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.
OTHER: 8 week wait; Participant waits for 8 weeks after their baseline assessment before commencing therapy.	Other: Behavioural Activation (BA); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: Devon Partnership NHS Trust
• Investigators: Principal Investigator: Kim A Wright, PhD, University of Exeter

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (ACTUAL): September 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Behavioural Activation; Bipolar Depression; Case Series; Multiple Baseline
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: 237525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data that underlie results in a publication.
• IPD Sharing Time Frame: Access will be possible from date of publication.
• IPD Sharing Access Criteria: The research database will be registered with the University of Exeter public access database. The dataset will be anonymous and will be registered with a metadata only record, allowing the research team to control access to the dataset, restricting it to appropriately qualified third parties.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No