Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2019-05-07
2025-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Behavioural Activation (Intervention)
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.
Behavioural Activation
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).
Waitlist (Control)
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.
No interventions assigned to this group
Interventions
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Behavioural Activation
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).
Eligibility Criteria
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Inclusion Criteria
* Must be able to provide written informed consent
* Must be able to attend program sessions
Exclusion Criteria
* Primary diagnosis other Bipolar Disorder.
18 Years
65 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Zainab Samaan (Zena)
Associate Professor
Principal Investigators
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Zainab Samaan, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRAVE for Bipolar: 5924
Identifier Type: -
Identifier Source: org_study_id