Behavioural Activation for Bipolar Depression: A Case Series

NCT03658824 | Completed

• 1 other identifier: 237525
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Behavioural Activation; Bipolar Disorder; Bipolar Depression; Multiple Baseline; Case Series

Outcome Measures

Primary Outcomes (6)

• 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

• No significant adverse reaction for participants

  Participant reports of adverse events elicited by researchers and therapists.

  through study completion, an average of 7 months

• Qualitative feedback from participants

  Written and verbal feedback of participants

  through study completion, an average of 7 months

• Qualitative feedback from therapists

  Feedback given in qualitative interviews with therapists

  through study completion, an average of 7 months

• Therapy uptake rate

  Number of participants randomised who attend at least 1 treatment session

  through study completion, an average of 7 months

• Therapy completion rate

  Proportion of participants that attend at least 8 treatment sessions

  through study completion, an average of 7 months

Secondary Outcomes (13)

• Altman Self-Rating Mania Scale (ASRM)

  1 week

• Work and Social Adjustment Scale (WSAS)

  24 hours

• Structured Clinical Interview for Depression (SCID)

  Six months

• Hamilton Depression Scale (HAM-D)

  1 week

• Brief Quality of Life in Bipolar Disorder (Brief QoLBD)

  1 week

Study Arms (6)

3 week wait

OTHER

Participant waits for 3 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

4 week wait

OTHER

Participant waits for 4 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

5 week wait

OTHER

Participant waits for 5 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

6 week wait

OTHER

Participant waits for 6 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

7 week wait

OTHER

Participant waits for 7 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

8 week wait

OTHER

Participant waits for 8 weeks after their baseline assessment before commencing therapy.

Other: Behavioural Activation (BA)

Interventions

Behavioural Activation (BA) OTHER

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.

3 week wait; 4 week wait; 5 week wait; 6 week wait; 7 week wait; 8 week wait

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Exeter: lead
• Devon Partnership NHS Trust: collaborator

Study Sites (1)

University of Exeter

Exeter, EX4 4QG, United Kingdom

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Kim A Wright, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: September 5, 2018
• Study Start: September 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Access will be possible from date of publication.
• Access Criteria: The research database will be registered with the University of Exeter public access database. The dataset will be anonymous and will be registered with a metadata only record, allowing the research team to control access to the dataset, restricting it to appropriately qualified third parties.

Locations

GB (1)