Clinical trial NCT03658824: Behavioural Activation for Bipolar Depression: A Case Series
Official title: Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Keywords: Behavioural Activation
Bipolar Disorder
Bipolar Depression
Multiple Baseline
Case Series
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Devon Partnership NHS Trust
First posted: 2018-09-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
timeFrame: through study completion, an average of 7 months
measure: No significant adverse reaction for participants
timeFrame: through study completion, an average of 7 months
measure: Qualitative feedback from participants
timeFrame: through study completion, an average of 7 months
measure: Qualitative feedback from therapists
timeFrame: through study completion, an average of 7 months
measure: Therapy uptake rate
timeFrame: through study completion, an average of 7 months
measure: Therapy completion rate
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: Altman Self-Rating Mania Scale (ASRM)
timeFrame: 1 week
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 24 hours
measure: Structured Clinical Interview for Depression (SCID)
timeFrame: Six months
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 1 week
measure: Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
timeFrame: 1 week
measure: Bech-Rafaelsen Mania Scale
timeFrame: 1 week
measure: Beck Depression Inventory (BDI)
timeFrame: 1 week
measure: General Anxiety Disorder Assessment - 7 (GAD7)
timeFrame: 2 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: 1 week
measure: Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: 2 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 1 week
measure: Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale
timeFrame: 6 months
measure: Questions about Suffering, Struggling and Engagement in Valued Activities
timeFrame: 24 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
affiliation: University of Exeter
name: Kim A Wright, PhD
role: PRINCIPAL_INVESTIGATOR
References: