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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of the study period (14 weeks)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Economic evaluation of the BA program in the study population.
Test the effects of BA on changes in health parameters

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
2019
N/A
~50

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,424 Total Patients Enrolled
4 Trials studying Bipolar Disorder
314 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If I enroll, am I eligible to participate in this research?

"manic disorder patients that want to participate in this study must be between 18-65 years old. Currently, the study is looking for 120 participants in total."

Answered by AI

Are elderly citizens welcome in this clinical trial?

"According to the rules set out by the researchers, only patients aged 18 to 65 can take part in this clinical trial. There are however, 261 trials for patients under 18 and 690 for those over 65."

Answered by AI

How many individuals are under this clinical trial's care?

"The latest information available on clinicaltrials.gov suggests that this research is still looking for participants. This particular trial was originally posted on 05/07/2019 and was updated on 09/15/2021. So far, only 1 site has been used to enroll the 120 participants needed."

Answered by AI

Are there any current openings for people who would like to participate in this experiment?

"From what is detailed on clinicaltrials.gov, this study is still recruiting patients. The listing for this clinical trial was first made on May 7th, 2019 and was edited as recently as September 15th, 2021."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
Texas
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0
3+
What site did they apply to?
St. Joseph's Healthcare Hamilton

Why did patients apply to this trial?

Currently unmedicated need help to get back in track. Try the treatments to remedy my mental health problems.
PatientReceived 2+ prior treatments
To have a chance of some relief as all options so far have failed. I am hoping to explore additional options for the treatment of my Bipolar disorder so I can have long-term stability.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Wondering if the trial is available remotely? How long does the process take and is there any compensation?
PatientReceived no prior treatments
Is the only location based in Canada? Are there any places in Maryland, US?
PatientReceived 1 prior treatment
How long does trial last ?. As international traveller do i have to pay for my air fair to usa ?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Behavioural Activation Therapy for Bipolar Disorder
Zainab Samaan (Zena) 2019. "Behavioural Activation Therapy for Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04317859.
All > Bipolar Disorder
~22 spots leftby Jun 2025
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