NCT05223959Completed
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 303 (actual)
- First submitted
- 25 Jan 2022
- Start date
- 20 Jun 2022
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Pakistan Institute of Living and Learning
- Diseases
- Bipolar disorder
- NCT number
- NCT05223959
What you commit to
- Study type: Interventional
- Participants enrolled: 303
- From 20 Jun 2022 to the primary completion date, 30 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active substance use disorder, based on DSM-5 criteria
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lahore General Hospital Coordinator of this site? Confirm its status | Lahore | Pakistan | Unknown status |
Related publications
- Culturally adapted psychoeducation for bipolar disorder: a multicentre, assessor-masked, randomised controlled trial.EClinicalMedicine · 2026 · PMID 42964307
This page is information, not medical advice. Discuss any trial with your doctor.