Behavioural Activation for Bipolar Depression: A Case Series

Bipolar Depression Clinical Trial

— BA-BD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658824
• Other study ID #: 237525
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	Devon Partnership NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	No significant adverse reaction for participants	Participant reports of adverse events elicited by researchers and therapists.	through study completion, an average of 7 months
Primary	Qualitative feedback from participants	Written and verbal feedback of participants	through study completion, an average of 7 months
Primary	Qualitative feedback from therapists	Feedback given in qualitative interviews with therapists	through study completion, an average of 7 months
Primary	Therapy uptake rate	Number of participants randomised who attend at least 1 treatment session	through study completion, an average of 7 months
Primary	Therapy completion rate	Proportion of participants that attend at least 8 treatment sessions	through study completion, an average of 7 months
Secondary	Altman Self-Rating Mania Scale (ASRM)	5 item self-report measure of hypomania symptoms over the past week	1 week
Secondary	Work and Social Adjustment Scale (WSAS)	5 item self-report scale of functional impairment attributable to an identified problem	24 hours
Secondary	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
Secondary	Hamilton Depression Scale (HAM-D)	17 item observer-rated scale measuring symptoms of depression over the past week	1 week
Secondary	Brief Quality of Life in Bipolar Disorder (Brief QoLBD)	12 item self-report measure of disorder-specific quality of life	1 week
Secondary	Bech-Rafaelsen Mania Scale	11 item observer-rated scale measuring the severity of manic states	1 week
Secondary	Beck Depression Inventory (BDI)	21 item self-report measure of depressive symptoms and attitudes	1 week
Secondary	General Anxiety Disorder Assessment - 7 (GAD7)	7 item self-report measure of anxiety symptoms	2 weeks
Secondary	Behavioral Activation for Depression Scale (BADS)	25 item self-report measure of changes in activation and avoidance over the past week	1 week
Secondary	Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)	7-item self-report measure of wellbeing	2 weeks
Secondary	Snaith-Hamilton Pleasure Scale (SHAPS)	14 item self-report measure of level of anhedonia	1 week
Secondary	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
Secondary	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