Bipolar DisorderNCT04317859
Behavioural Activation Therapy for Bipolar Disorder
A study testing Behavioural Activation in people with Bipolar Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Mood disorders including bipolar disorder and depression are common disabling disorders with depression affecting 11.2 to 16.0% of the general population and the lifetime prevalence of bipolar disorders at an estimated 4.4%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Behavioural Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2019to 1 Jun 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Bipolar Disorder
- Must be able to provide written informed consent
- Must be able to attend program sessions
Who cannot join
- Inability to understand written and spoken English
- Primary diagnosis other Bipolar Disorder.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L4E4S4
Jacqueline Hudson, 905-522-1155 ext. 39215, jhudson@mcmaster.ca
Zainab Samaan, MBChB, PhD
About this study
Mood disorders including bipolar disorder and depression are common disabling disorders with depression affecting 11.2 to 16.0% of the general population and the lifetime prevalence of bipolar disorders at an estimated 4.4%. Although treatment with antidepressants medications is common and effective in some patients, 42.7% of patients show inadequate response to treatment with antidepressants and a large proportion (55.3%) continue to have ongoing depressive symptoms. Psychological and behavioural interventions such as cognitive behavioural therapy (CBT) and behavioural activation (BA) are effective treatment for depression alone or in combination with antidepressants. Depression can also occur in the context of bipolar disorder which is characterized by recurrent episodes of depression and mania (DSM-5). The depressive episodes within bipolar disorder may be similar to depressive disorder, however the management of these episodes is fraught with the challenge that antidepressant pharmacotherapy may precipitate manic episodes and lead to further destabilization of bipolar disorder. Therefore, an alternative to antidepressants and additional therapies are needed to support patients' recovery and mood stability, as well as to achieve better treatment response and remission. BA is not currently available in a structured format and has not been tested for its effectiveness in bipolar disorders in a specialized hospital-based program. The evidence for BA has been investigated in depression however the evidence for bipolar disorder is lacking, therefore this study aims to assess the effectiveness of BA as treatment for bipolar disorder.
Read the detailed description
This study is a pragmatic randomized controlled trial to test the effectiveness of behavioural activation in bipolar disorder. The pragmatic randomized controlled trial study design is a parallel 1:1 allocation comparing behavioural activation plus treatment as usual to waitlist control group plus treatment as usual. For this study the investigators will adopt the following principals simulating naturalistic real life clinical setting to test the study question based on the pragmatic design:
No restrictive inclusion criteria will be used. Adults with bipolar disorder will be asked to participate in this study Clinicians will deliver the BA program to participants randomized to receive the intervention The intervention will be an add-on to treatment as usual The comparison group will receive treatment as usual that may include medications, CBT and other therapies as required and decided by their clinical care The primary outcome is clinically relevant (improvement in depressive and manic symptoms)
Both the intervention and control groups will be assessed as intention to treat analysis with no measures to improve adherence to the study intervention or the comparator.
Patients with a diagnosis of bipolar disorders attending the mood disorders clinic, referred for assessment of bipolar disorder at the clinic or referred from community or other hospital services to the mood disorders clinic will be approached for participation in the study. In addition, family practices in the community will be informed of the study and asked to refer directly to the trial. Following initial screening for eligibility, potential participants will be asked to provide written informed consent prior to any study related procedures.
The investigators will employ a parallel group design to evaluate the effects of behavioural activation intervention to improve bipolar disorder-related outcomes. Eligible and consenting patients will be randomly allocated to the intervention or control arms using a 1:1 allocation ratio. Allocations will be generated using the computerized system. The randomization will use a block randomization system of block sizes of 2, 4 and 6. Allocation will be conducted by a research personnel who is not a clinician and will not know the participant clinical status to maintain allocation concealment.
This trial is an open label trial as blinding is not possible for participants (behavioural activation intervention) or the clinician administering the intervention.
- Conditions
- Bipolar Disorder
- Being tested
- Behavioural Activation
- Keywords
- Behavioural Activation, Bipolar Disorder
- 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 ActivationBehavioural
Behavioural Activation (BA) is a therapy previously shown to be effective in depressive disorders. This form of therapy involves modification of activities in order to change perceptions of specific situations, thereby improving mood. The BA treatment program will consist of 18 two-hour visits over 14 weeks (twice weekly group visits for the first 8 weeks, followed by two individual visits over 6 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Behavioural Activation (Intervention) | Experimental | Originally a component of Cognitive Therapy, Behavioural Activation is the use of strategies such as activity scheduling, master/pleasure ratings, and graded task assignments to modify one's perception of specific situations. Behavioural Activation involves the use of activities to improve life situations and mood symptoms. Receives: Behavioral: Behavioural Activation |
| Waitlist (Control) | No intervention | The Control group (waitlist) will receive treatment as usual while waiting to receive BA intervention (at the end of intervention group therapy time, which will consist of 18 sessions over an 14 week period). This group will be assessed by clinical staff that offer treatment as usual for mood symptoms and quality of life measures during the waiting time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms
The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms. Items in the BDI are scored on a scale of 0-63, where 63 is the maximum score and higher scores are associated with more severe symptoms.
Measured: End of the study period (14 weeks)
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on manic symptoms
The Altman Self-Rating Scale (ASRS) is administered to measure the effectiveness of BA on manic symptoms. The ASRS has 5 items and a maximum score of 20; higher scores are associated with increased severity.
Measured: End of the study period (14 weeks)
Secondary outcomes (2)
Test the effects of BA on changes in health parameters
Quality of Life, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), Short-Form 12 Health Survey (SF-12), and the Work and Social Adjustment Scale (WSAS). The Q-LES-Q-SF is a 14-item questionnaire scored between 0% and 100%, where higher percentages are indicative of a higher QOL. WSAS scores items between 0 (indicating no impairment) and 8 (indicating severe impairment); total scores greater than 20 indicate severe psychopathology and symptomology. The SF-12 generates two summary scores, the physical component score (PCS) and the mental component score (MCS); scores range between 0 and 100, where 100 is associated with the highest level of health state.
Measured: End of the study period (14 weeks)
Economic evaluation of the BA program in the study population.
Economic evaluation of the BA program will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L), a commonly used measure of health status and quality of life in a variety of clinical conditions. Each of 5 items are scored between 0 to 4; the maximum score of the EQ-5D-5L is 1, with higher scores being associated with poorer health.
Measured: End of the study period (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start7 May 2019
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton
- Investigators
- Zainab Samaan, MBChB, PhD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317859
- Sponsor's protocol ID
- BRAVE for Bipolar: 5924
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation Therapy for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04317859
- Acronym / sponsor ID
- BRAVE for Bipolar: 5924
- Conditions
- Bipolar Disorder
- Keywords
- Behavioural Activation, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Mar 2020 (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.
Mood disorders including bipolar disorder and depression are common disabling disorders with depression affecting 11.2 to 16.0% of the general population and the lifetime prevalence of bipolar disorders at an estimated 4.4%. Although treatment with antidepressants medications is common and effective in some patients, 42.7% of patients show inadequate response to treatment with antidepressants and a large proportion (55.3%) continue to have ongoing depressive symptoms. Psychological and behavioural interventions such as cognitive behavioural therapy (CBT) and behavioural activation (BA) are effective treatment for depression alone or in combination with antidepressants. Depression can also occur in the context of bipolar disorder which is characterized by recurrent episodes of depression and mania (DSM-5). The depressive episodes within bipolar disorder may be similar to depressive disorder, however the management of these episodes is fraught with the challenge that antidepressant pharmacotherapy may precipitate manic episodes and lead to further destabilization of bipolar disorder. Therefore, an alternative to antidepressants and additional therapies are needed to support patients' recovery and mood stability, as well as to achieve better treatment response and remission. BA is not currently available in a structured format and has not been tested for its effectiveness in bipolar disorders in a specialized hospital-based program. The evidence for BA has been investigated in depression however the evidence for bipolar disorder is lacking, therefore this study aims to assess the effectiveness of BA as treatment for bipolar disorder.
Detailed description
This study is a pragmatic randomized controlled trial to test the effectiveness of behavioural activation in bipolar disorder. The pragmatic randomized controlled trial study design is a parallel 1:1 allocation comparing behavioural activation plus treatment as usual to waitlist control group plus treatment as usual. For this study the investigators will adopt the following principals simulating naturalistic real life clinical setting to test the study question based on the pragmatic design:
No restrictive inclusion criteria will be used. Adults with bipolar disorder will be asked to participate in this study Clinicians will deliver the BA program to participants randomized to receive the intervention The intervention will be an add-on to treatment as usual The comparison group will receive treatment as usual that may include medications, CBT and other therapies as required and decided by their clinical care The primary outcome is clinically relevant (improvement in depressive and manic symptoms)
Both the intervention and control groups will be assessed as intention to treat analysis with no measures to improve adherence to the study intervention or the comparator.
Patients with a diagnosis of bipolar disorders attending the mood disorders clinic, referred for assessment of bipolar disorder at the clinic or referred from community or other hospital services to the mood disorders clinic will be approached for participation in the study. In addition, family practices in the community will be informed of the study and asked to refer directly to the trial. Following initial screening for eligibility, potential participants will be asked to provide written informed consent prior to any study related procedures.
The investigators will employ a parallel group design to evaluate the effects of behavioural activation intervention to improve bipolar disorder-related outcomes. Eligible and consenting patients will be randomly allocated to the intervention or control arms using a 1:1 allocation ratio. Allocations will be generated using the computerized system. The randomization will use a block randomization system of block sizes of 2, 4 and 6. Allocation will be conducted by a research personnel who is not a clinician and will not know the participant clinical status to maintain allocation concealment.
This trial is an open label trial as blinding is not possible for participants (behavioural activation intervention) or the clinician administering the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural Activation (Intervention) | Experimental | Behavioral: Behavioural ActivationOriginally a component of Cognitive Therapy, Behavioural Activation is the use of strategies such as activity scheduling, master/pleasure ratings, and graded task assignments to modify one's perception of specific situations. Behavioural Activation involves the use of activities to improve life situations and mood symptoms. |
| Waitlist (Control) | No intervention | –The Control group (waitlist) will receive treatment as usual while waiting to receive BA intervention (at the end of intervention group therapy time, which will consist of 18 sessions over an 14 week period). This group will be assessed by clinical staff that offer treatment as usual for mood symptoms and quality of life measures during the waiting time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Bipolar Disorder
- Must be able to provide written informed consent
- Must be able to attend program sessions
Key exclusion criteria (2 listed)
- Inability to understand written and spoken English
- Primary diagnosis other Bipolar Disorder.
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 ActivationBehavioural Activation (BA) is a therapy previously shown to be effective in depressive disorders. This form of therapy involves modification of activities in order to change perceptions of specific situations, thereby improving mood. The BA treatment program will consist of 18 two-hour visits over 14 weeks (twice weekly group visits for the first 8 weeks, followed by two individual visits over 6 weeks). | Behavioural | Behavioural Activation (Intervention) |
Primary outcome
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms
Time frame: End of the study period (14 weeks)
The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms. Items in the BDI are scored on a scale of 0-63, where 63 is the maximum score and higher scores are associated with more severe symptoms.
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on manic symptoms
Time frame: End of the study period (14 weeks)
The Altman Self-Rating Scale (ASRS) is administered to measure the effectiveness of BA on manic symptoms. The ASRS has 5 items and a maximum score of 20; higher scores are associated with increased severity.
2 secondary outcomes
Test the effects of BA on changes in health parameters
Time frame: End of the study period (14 weeks)
Economic evaluation of the BA program in the study population.
Time frame: End of the study period (14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Zainab Samaan, MBChB, PhD principal investigator
St. Joseph's Healthcare Hamilton
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 in people with Bipolar Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Hudson (905.522.1155 ext. 39215, jhudson@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms (time frame: End of the study period (14 weeks)). The study lists 2 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 27 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.