Bipolar DepressionBA-BDNCT03658824
Behavioural Activation for Bipolar Depression: A Case Series
A study testing Behavioural Activation (BA) in people with Bipolar Depression, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Behavioural Activation (BA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation
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
- Being tested
- Behavioural Activation (BA)
- Keywords
- Behavioural Activation, Bipolar Disorder, Bipolar Depression, Multiple Baseline, Case Series
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 week wait | Other | Participant waits for 3 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
| 4 week wait | Other | Participant waits for 4 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
| 5 week wait | Other | Participant waits for 5 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
| 6 week wait | Other | Participant waits for 6 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
| 7 week wait | Other | Participant waits for 7 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
| 8 week wait | Other | Participant waits for 8 weeks after their baseline assessment before commencing therapy. Receives: Other: Behavioural Activation (BA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Measured: through study completion, an average of 7 months
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists.
Measured: through study completion, an average of 7 months
Qualitative feedback from participants
Written and verbal feedback of participants
Measured: through study completion, an average of 7 months
Qualitative feedback from therapists
Feedback given in qualitative interviews with therapists
Measured: through study completion, an average of 7 months
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Measured: through study completion, an average of 7 months
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Measured: through study completion, an average of 7 months
Secondary outcomes (13)
Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Measured: 1 week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Measured: 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
Measured: Six months
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Measured: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
Measured: 1 week
Bech-Rafaelsen Mania Scale
11 item observer-rated scale measuring the severity of manic states
Measured: 1 week
Beck Depression Inventory (BDI)
21 item self-report measure of depressive symptoms and attitudes
Measured: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Measured: 2 weeks
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Measured: 1 week
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
7-item self-report measure of wellbeing
Measured: 2 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Measured: 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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Sep 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Devon Partnership NHS Trust
- Responsible party
- Sponsor
- Investigators
- Kim A Wright, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658824
- Sponsor's protocol ID
- 237525
- Acronym
- BA-BD
- Status last verified
- Apr 2021
- First submitted
- 26 Jul 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation for Bipolar Depression (BA-BD): A Case Series Evaluation
- ClinicalTrials.gov ID
- NCT03658824
- Acronym / sponsor ID
- BA-BD / 237525
- Conditions
- Bipolar Depression
- Keywords
- Behavioural Activation, Bipolar Disorder, Bipolar Depression, Multiple Baseline, Case Series
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Devon Partnership NHS Trust
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| 3 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 3 weeks after their baseline assessment before commencing therapy. |
| 4 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 4 weeks after their baseline assessment before commencing therapy. |
| 5 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 5 weeks after their baseline assessment before commencing therapy. |
| 6 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 6 weeks after their baseline assessment before commencing therapy. |
| 7 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 7 weeks after their baseline assessment before commencing therapy. |
| 8 week wait | Other | Other: Behavioural Activation (BA)Participant waits for 8 weeks after their baseline assessment before commencing therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural Activation (BA)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. | Other | 3 week wait, 4 week wait, 5 week wait, 6 week wait, 7 week wait, 8 week wait |
Primary outcome
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)
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.
Qualitative feedback from participants
Time frame: through study completion, an average of 7 months
Written and verbal feedback of participants
Qualitative feedback from therapists
Time frame: through study completion, an average of 7 months
Feedback given in qualitative interviews with therapists
Therapy uptake rate
Time frame: through study completion, an average of 7 months
Number of participants randomised who attend at least 1 treatment session
Therapy completion rate
Time frame: through study completion, an average of 7 months
Proportion of participants that attend at least 8 treatment sessions
13 secondary outcomes
Altman Self-Rating Mania Scale (ASRM)
Time frame: 1 week
Work and Social Adjustment Scale (WSAS)
Time frame: 24 hours
Structured Clinical Interview for Depression (SCID)
Time frame: Six months
Hamilton Depression Scale (HAM-D)
Time frame: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
Time frame: 1 week
Bech-Rafaelsen Mania Scale
Time frame: 1 week
Beck Depression Inventory (BDI)
Time frame: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
Time frame: 2 weeks
Behavioral Activation for Depression Scale (BADS)
Time frame: 1 week
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time frame: 2 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: 1 week
Positive and Negative Urgency Subscales of the UPPS-P Impulsive Behavior Scale
Time frame: 6 months
Questions about Suffering, Struggling and Engagement in Valued Activities
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim A Wright, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation (BA) in people with Bipolar Depression, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) (time frame: through study completion, an average of 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.