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Behavioural Activation Therapy for Bipolar Disorder

N/A
Recruiting
Led By Zainab Samaan, MBChB, PhD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of Bipolar Disorder
Must be able to attend program sessions
Must not have
Primary diagnosis other than Bipolar Disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of the study period (14 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the effectiveness of behavioural activation as treatment for bipolar disorder.

Who is the study for?
This trial is for individuals who can give written consent, attend program sessions, and have a clinical diagnosis of Bipolar Disorder. It's not suitable for those whose primary diagnosis isn't Bipolar Disorder or who can't understand English.
What is being tested?
The trial tests Behavioural Activation (BA) therapy as an alternative to antidepressants for treating bipolar disorder. BA hasn't been structured or tested in hospital programs specifically for bipolar disorder before.
What are the potential side effects?
Since the intervention involves psychological and behavioural therapy rather than medication, typical drug side effects are not expected. However, participants may experience emotional discomfort during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Bipolar Disorder.
Select...
I can attend all required program sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My primary diagnosis is not Bipolar Disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of the study period (14 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of the study period (14 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms
Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on manic symptoms
Secondary study objectives
Economic evaluation of the BA program in the study population.
Test the effects of BA on changes in health parameters

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioural Activation (Intervention)Experimental Treatment1 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.
Group II: Waitlist (Control)Active Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioural Activation
2021
N/A
~180

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
200 Previous Clinical Trials
26,669 Total Patients Enrolled
4 Trials studying Bipolar Disorder
271 Patients Enrolled for Bipolar Disorder
Zainab Samaan, MBChB, PhDPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
1 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

Behavioural Activation Clinical Trial Eligibility Overview. Trial Name: NCT04317859 — N/A
Bipolar Disorder Research Study Groups: Behavioural Activation (Intervention), Waitlist (Control)
Behavioural Activation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04317859 — N/A
Bipolar Disorder Clinical Trial 2023: Behavioural Activation Highlights & Side Effects. Trial Name: NCT04317859 — N/A
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT04317859 — N/A
~12 spots leftby Jun 2025
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