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

NCT ID: NCT05223959

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2026-06-30

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, 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.

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. Therefore, the current study aims to test the effectiveness of Culturally adapted PsychoEducation (CaPE) intervention for people with BD in Pakistan. The study will include a total of N=300 people with BD from psychiatric units of teaching and non-teaching hospitals in 8 centres across Pakistan including Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad, Shaheed Benazirabad and Quetta. Consented participants meeting eligibility criteria will be randomised in a 1:1 allocation to CaPE or TAU. Randomization will be computer generated and use a random permuted block method with variable block sizes stratified by site, bipolar type (I or II) and self-reported sex. Participants in CaPE intervention group will receive 12-weekly one-to-one psychoeducation sessions. Each CaPE session will last for approximately 1 hour, 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). Sessions will be delivered by trained psychologists who will receive regular weekly supervision to maintain fidelity. The other group will receive TAU/control group. Assessments will be carried out at baseline, months 3, 6, and 12 either in-person and/or via secure videoconference software (alternatives to in-person for COVID-19 or travel restrictions) by trained, blinded research analysts (RAs). The treatment groups will be compared with each other at baseline and then at subsequent follow-ups at 3, 6 and 12 months. We will also conduct in-depth, one-to-one interviews with service users from the intervention arm (15-20), carers (15-20) and all therapists involved in the trial. A cost-utility analysis from a healthcare system and societal perspective will be conducted to establish the cost-effectiveness of CaPE against TAU.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CaPE Intervention

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.

Group Type: EXPERIMENTAL

Culturally adapted Psychoeducation

Intervention Type: 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).

Treatment as Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Ishrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Nasim Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Locations

Lahore General Hospital

Lahore, Select An Option…, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muqaddas Asif

Role: CONTACT

muqaddas.asif@pill.org.pk

042-35842310

Madeha Umer

Role: CONTACT

Madeha.Umer@camh.ca

Facility Contacts

MUQADDAS ASIF

Role: primary

References

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.

Reference Type: DERIVED

PMID: 36426568 (View on PubMed)

Other Identifiers

PILL-CaPE-002

Identifier Type: -

Identifier Source: org_study_id