Behavioural Activation for Bipolar Depression: A Case Series
- Conditions
- Bipolar Depression
- Interventions
- Other: Behavioural Activation (BA)
- Registration Number
- NCT03658824
- Lead Sponsor
- University of Exeter
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 week wait Behavioural Activation (BA) Participant waits for 3 weeks after their baseline assessment before commencing therapy. 7 week wait Behavioural Activation (BA) Participant waits for 7 weeks after their baseline assessment before commencing therapy. 8 week wait Behavioural Activation (BA) Participant waits for 8 weeks after their baseline assessment before commencing therapy. 4 week wait Behavioural Activation (BA) Participant waits for 4 weeks after their baseline assessment before commencing therapy. 5 week wait Behavioural Activation (BA) Participant waits for 5 weeks after their baseline assessment before commencing therapy. 6 week wait Behavioural Activation (BA) Participant waits for 6 weeks after their baseline assessment before commencing therapy.
- Primary Outcome Measures
Name Time Method Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) through study completion, an average of 7 months Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
No significant adverse reaction for participants through study completion, an average of 7 months Participant reports of adverse events elicited by researchers and therapists.
Qualitative feedback from participants through study completion, an average of 7 months Written and verbal feedback of participants
Qualitative feedback from therapists through study completion, an average of 7 months Feedback given in qualitative interviews with therapists
Therapy completion rate through study completion, an average of 7 months Proportion of participants that attend at least 8 treatment sessions
Therapy uptake rate through study completion, an average of 7 months Number of participants randomised who attend at least 1 treatment session
- Secondary Outcome Measures
Name Time Method Brief Quality of Life in Bipolar Disorder (Brief QoLBD) 1 week 12 item self-report measure of disorder-specific quality of life
Beck Depression Inventory (BDI) 1 week 21 item self-report measure of depressive symptoms and attitudes
Structured Clinical Interview for Depression (SCID) Six months 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
Behavioral Activation for Depression Scale (BADS) 1 week 25 item self-report measure of changes in activation and avoidance over the past week
Snaith-Hamilton Pleasure Scale (SHAPS) 1 week 14 item self-report measure of level of anhedonia
Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale 6 months 14 and 12 items respectively, these self-report scales measure tendency to respond impulsively to positive or negative feelings
Questions about Suffering, Struggling and Engagement in Valued Activities 24 hours 3 item self-report measure of core hypothesised process of change in behavioural activation, namely reduction in avoidance behaviours and increase in rewarding behaviours
Altman Self-Rating Mania Scale (ASRM) 1 week 5 item self-report measure of hypomania symptoms over the past week
Bech-Rafaelsen Mania Scale 1 week 11 item observer-rated scale measuring the severity of manic states
Work and Social Adjustment Scale (WSAS) 24 hours 5 item self-report scale of functional impairment attributable to an identified problem
Hamilton Depression Scale (HAM-D) 1 week 17 item observer-rated scale measuring symptoms of depression over the past week
General Anxiety Disorder Assessment - 7 (GAD7) 2 weeks 7 item self-report measure of anxiety symptoms
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) 2 weeks 7-item self-report measure of wellbeing
Trial Locations
- Locations (1)
University of Exeter
🇬🇧Exeter, United Kingdom