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RECRUITINGINTERVENTIONAL

Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - On stable psychiatric medication regimen for at least 3 months - Resident of the trial catchment area. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Culturally adapted Psychoeducation

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)

Lahore General Hospital
Lahore, Select An Option…, Pakistan