Culturally adapted psychoeducation for bipolar disorder in Pakistan
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
NA · Pakistan Institute of Living and Learning · NCT05223959
This study is testing a new, culturally tailored education program for people in Pakistan with bipolar disorder to see if it helps them stay well longer compared to standard treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pakistan Institute of Living and Learning (other) |
| Locations | 1 site (Lahore, Select An Option…) |
| Trial ID | NCT05223959 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a culturally adapted psychoeducation (CaPE) intervention compared to standard treatment in reducing recurrence rates for individuals with bipolar disorder in remission in Pakistan. The study will involve 300 participants from various psychiatric units across eight centers in Pakistan, who will be randomly assigned to receive either CaPE or treatment as usual. The CaPE intervention consists of 12 weekly one-on-one sessions led by trained psychologists, focusing on psychoeducation topics and related exercises. Assessments will be conducted at baseline and at 3, 6, and 12 months to measure clinical outcomes, quality of life, and cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and above with a diagnosis of bipolar disorder I or II who are currently in remission and stable on psychiatric medication.
Not a fit: Patients experiencing active substance use disorders, current recurrence of bipolar symptoms, or unstable living situations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the recurrence of bipolar disorder and improve the quality of life for patients in low-resource settings.
How similar studies have performed: While psychoeducation has shown effectiveness in other contexts, this specific culturally adapted approach in a low-resource setting is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lahore, Select An Option…
- Lahore General Hospital — Lahore, Select An Option…, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Muhammad Ishrat Husain, MD — Centre for Addiction and Mental Health
- Study coordinator: Muqaddas Asif
- Email: muqaddas.asif@pill.org.pk
- Phone: 042-35842310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder