Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized C… (NCT05223959) | Clinical Trial Compass
CompletedNot Applicable
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Pakistan303 participantsStarted 2022-06-20
Plain-language summary
Study objectives:
1. To determine the effectiveness of the CaPE intervention compared to treatment as usual (TAU) in reducing the time to recurrence for people with bipolar disorder (BD) I/II, currently in remission in Pakistan
2. To determine the impact of the CaPE intervention compared to TAU on clinical outcomes, quality of life and functioning; and
3. To estimate the cost-effectiveness of CaPE in a low-resource setting (i.e., Pakistan) (if the RCT confirms the effectiveness of CaPE in BD.
Study design and setting:
This will be a multi-centre, assessor blind, individual, parallel-arm randomized controlled trial (RCT) with Pakistani patients with BD.
Sample Size:
The study aims to recruit a total of N=300 participants in total.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult outpatients age 18 and above
* Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) bipolar disorder (both BD I and BD II), currently in remission, confirmed by Structured Clinical Interview for DSM-5 (SCID)
* Currently euthymic (Hamilton Depression Rating Scale, HDRS-17 \< 8 and Young Mania Rating Scale, YMRS \<8)
* Able to give written informed consent
* On stable psychiatric medication regimen for at least 3 months
* Resident of the trial catchment area.
Exclusion Criteria:
* Active substance use disorder, based on DSM-5 criteria
* Currently experiencing recurrence (mania, hypomania, mixed or depressive
* Active suicidal ideation
* Unstable residential arrangements that reduce likelihood of being available for the duration of trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Longitudinal Interval Follow-up Evaluation
Timeframe: Change in scores from baseline to months 3, 6, and 12