Skip to main content
OpenTrials
Completed

NCT Number: NCT03658824

Behavioural Activation for Bipolar Depression: A Case Series

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, EX4 4QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)

    Time frame: through study completion, an average of 7 months

    Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)

  2. No significant adverse reaction for participants

    Time frame: through study completion, an average of 7 months

    Participant reports of adverse events elicited by researchers and therapists.

  3. Qualitative feedback from participants

    Time frame: through study completion, an average of 7 months

    Written and verbal feedback of participants

  4. Qualitative feedback from therapists

    Time frame: through study completion, an average of 7 months

    Feedback given in qualitative interviews with therapists

  5. Therapy uptake rate

    Time frame: through study completion, an average of 7 months

    Number of participants randomised who attend at least 1 treatment session

  6. Therapy completion rate

    Time frame: through study completion, an average of 7 months

    Proportion of participants that attend at least 8 treatment sessions

Secondary outcomes

  1. Altman Self-Rating Mania Scale (ASRM)

    Time frame: 1 week

    5 item self-report measure of hypomania symptoms over the past week

  2. Work and Social Adjustment Scale (WSAS)

    Time frame: 24 hours

    5 item self-report scale of functional impairment attributable to an identified problem

  3. Structured Clinical Interview for Depression (SCID)

    Time frame: 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

  4. Hamilton Depression Scale (HAM-D)

    Time frame: 1 week

    17 item observer-rated scale measuring symptoms of depression over the past week

  5. Brief Quality of Life in Bipolar Disorder (Brief QoLBD)

    Time frame: 1 week

    12 item self-report measure of disorder-specific quality of life

  6. Bech-Rafaelsen Mania Scale

    Time frame: 1 week

    11 item observer-rated scale measuring the severity of manic states

  7. Beck Depression Inventory (BDI)

    Time frame: 1 week

    21 item self-report measure of depressive symptoms and attitudes

  8. General Anxiety Disorder Assessment - 7 (GAD7)

    Time frame: 2 weeks

    7 item self-report measure of anxiety symptoms

  9. Behavioral Activation for Depression Scale (BADS)

    Time frame: 1 week

    25 item self-report measure of changes in activation and avoidance over the past week

  10. Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

    Time frame: 2 weeks

    7-item self-report measure of wellbeing

  11. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: 1 week

    14 item self-report measure of level of anhedonia

  12. Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale

    Time frame: 6 months

    14 and 12 items respectively, these self-report scales measure tendency to respond impulsively to positive or negative feelings

  13. Questions about Suffering, Struggling and Engagement in Valued Activities

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Devon Partnership NHS Trust

Registry information

Official study title

Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation

Acronym: BA-BD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.