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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
University of Exeter
Exeter, United Kingdom
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Time frame: through study completion, an average of 7 months
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists.
Time frame: through study completion, an average of 7 months
Qualitative feedback from participants
Written and verbal feedback of participants
Time frame: through study completion, an average of 7 months
Qualitative feedback from therapists
Feedback given in qualitative interviews with therapists
Time frame: through study completion, an average of 7 months
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Time frame: through study completion, an average of 7 months
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Time frame: through study completion, an average of 7 months
Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Time frame: 1 week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Time frame: 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
Time frame: Six months
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Time frame: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
Time frame: 1 week
Bech-Rafaelsen Mania Scale
11 item observer-rated scale measuring the severity of manic states
Time frame: 1 week
Beck Depression Inventory (BDI)
21 item self-report measure of depressive symptoms and attitudes
Time frame: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Time frame: 2 weeks
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Time frame: 1 week
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
7-item self-report measure of wellbeing
Time frame: 2 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Time frame: 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
Time frame: 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
Time frame: 24 hours
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