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

NCT05223959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Pakistan Institute of Living and Learning

    lead OTHER

Principal Investigators

  • Muhammad Ishrat Husain, MD · Centre for Addiction and Mental Health

  • Nasim Chaudhry, MD · Pakistan Institute of Living and Learning

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2025-03-30
Completion
2025-06-28

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223959 on ClinicalTrials.gov