Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Pakistan Institute of Living and Learning
300 participants
Jun 20, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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.
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Interventions
This is a culturally adapted psychoeducation program consisting of 12 sessions. Each CaPE session lasts for approximately 60 minutes, beginning with a 20-30-minute presentation on the topic of the day, followed by a related exercise (e.g., drawing a life chart or compiling a list of potential triggers for recurrence).
Locations(1)
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NCT05223959