Bipolar Depression
Conditions
Keywords
Behavioural Activation, Bipolar Disorder, Bipolar Depression, Multiple Baseline, Case Series
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.
Interventions
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.
Sponsors
Devon Partnership NHS Trust
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimise potential biases on the side of the researcher.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 uptake rate | through study completion, an average of 7 months | Number of participants randomised who attend at least 1 treatment session |
| Therapy completion rate | through study completion, an average of 7 months | Proportion of participants that attend at least 8 treatment sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Quality of Life in Bipolar Disorder (Brief QoLBD) | 1 week | 12 item self-report measure of disorder-specific quality of life |
| Bech-Rafaelsen Mania Scale | 1 week | 11 item observer-rated scale measuring the severity of manic states |
| Beck Depression Inventory (BDI) | 1 week | 21 item self-report measure of depressive symptoms and attitudes |
| Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) | 2 weeks | 7-item self-report measure of wellbeing |
| Behavioral Activation for Depression Scale (BADS) | 1 week | 25 item self-report measure of changes in activation and avoidance over the past week |
| 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 |
| General Anxiety Disorder Assessment - 7 (GAD7) | 2 weeks | 7 item self-report measure of anxiety symptoms |
| Snaith-Hamilton Pleasure Scale (SHAPS) | 1 week | 14 item self-report measure of level of anhedonia |
| Altman Self-Rating Mania Scale (ASRM) | 1 week | 5 item self-report measure of hypomania symptoms over the past week |
| Work and Social Adjustment Scale (WSAS) | 24 hours | 5 item self-report scale of functional impairment attributable to an identified problem |
| 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 |
| Hamilton Depression Scale (HAM-D) | 1 week | 17 item observer-rated scale measuring symptoms of depression over the past week |
Countries
United Kingdom
Outcome results
None listed