Status:
RECRUITING
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Lead Sponsor:
Pakistan Institute of Living and Learning
Collaborating Sponsors:
Centre for Addiction and Mental Health
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, curren...
Detailed Description
Psychoeducation (PE) is an effective adjunctive treatment option in BD, however, despite the clear benefits, there are only limited, underpowered studies of PE from LMICs, including Pakistan. Therefor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05223959
Start Date
June 20 2022
End Date
June 1 2026
Last Update
September 26 2022
Active Locations (1)
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1
Lahore General Hospital
Lahore, Select An Option…, Pakistan, 55000