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

NCT05223959 | Completed DMC

• 1 other identifier: PILL-CaPE-002
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives:

1. 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. 2.To determine the impact of the CaPE intervention compared to TAU on clinical outcomes, quality of life and functioning; and
3. 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Longitudinal Interval Follow-up Evaluation

  Longitudinal Interval Follow-up Evaluation (LIFE) is an integrated system for assessing the longitudinal course of psychiatric disorders. The assessment will consist of a semi-structured interview, during which an interviewer uses the LIFE to collect detailed psychosocial, psychopathologic, and treatment information for the follow-up interval. The weekly psychopathology measures are ordinal symptom-based scales with categories defined to match the criteria of the DSM-5.

  Change in scores from baseline to months 3, 6, and 12

Secondary Outcomes (8)

• Demographic Questionnaire

  Baseline

• Young Mania Rating Scale

  Change in scores from baseline to months 3, 6, and 12

• Hamilton Depression Rating Scale

  Change in scores from baseline to months 3, 6, and 12

• Quality of life scale

  Change in scores from baseline to months 3, 6, and 12

• Bipolar Recovery Questionnaire

  Change in scores from baseline to months 3, 6, and 12

Study Arms (2)

CaPE Intervention

EXPERIMENTAL

CaPE is a manualized intervention consisting of 12 one-to-one psychoeducation sessions, one session per week. Each session will last for 60 minutes. All sessions will be delivered by a trained therapist who will receive two months training from senior therapists before starting intervention.

Behavioral: Culturally adapted Psychoeducation

Treatment as Usual

NO INTERVENTION

Treatment as usual (TAU) will be ascertained by the participant's treating physician. Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.

Interventions

Culturally adapted Psychoeducation BEHAVIORAL

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).

CaPE Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: collaborator
• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Lahore General Hospital

Lahore, Select An Option…, 55000, Pakistan

Location

Related Publications (1)

• Husain MI, Umer M, Asif M, Khoso AB, Kiran T, Ansari M, Aslam H, Bhatia MR, Dogar FA, Husain MO, Khan HA, Mufti AA, Mulsant BH, Naeem F, Naqvi HA, de Oliviera C, Siddiqui MS, Tamizuddin A, Wang W, Zaheer J, Husain N, Chaudhry N, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial. BJPsych Open. 2022 Nov 25;8(6):e206. doi: 10.1192/bjo.2022.598.

  PMID: 36426568 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Muhammad Ishrat Husain, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Nasim Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: June 20, 2022
• Primary Completion: March 30, 2025
• Study Completion: June 28, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

PA (1)