- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04317859
Behavioural Activation Therapy for Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacqueline Hudson
- Phone Number: 39215 905.522.1155
- Email: jhudson@mcmaster.ca
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L4E4S4
- Recruiting
- St. Joseph's Healthcare Hamilton
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Contact:
- Jacqueline Hudson
- Phone Number: 39215 905-522-1155
- Email: jhudson@mcmaster.ca
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Principal Investigator:
- Zainab Samaan, MBChB, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of Bipolar Disorder
- Must be able to provide written informed consent
- Must be able to attend program sessions
Exclusion Criteria:
- Inability to understand written and spoken English
- Primary diagnosis other Bipolar Disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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).
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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End of the study period (14 weeks)
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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)
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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.
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End of the study period (14 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test the effects of BA on changes in health parameters
Time Frame: End of the study period (14 weeks)
|
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.
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End of the study period (14 weeks)
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Economic evaluation of the BA program in the study population.
Time Frame: End of the study period (14 weeks)
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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.
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End of the study period (14 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zainab Samaan, MBChB, PhD, St. Joseph's Healthcare Hamilton
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRAVE for Bipolar: 5924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Behavioural Activation
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