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

Bipolar Disorder Clinical Trial

— CaPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223959
• Other study ID #: PILL-CaPE-002
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: June 2026

Study information

• Verified date: September 2022
• Source: Pakistan Institute of Living and Learning
• Contact: Muqaddas Asif
• Phone: 042-35842310
• Email: muqaddas.asif[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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).

Locations

Country	Name	City	State
Pakistan	Lahore General Hospital	Lahore	Select An Option…

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning	Centre for Addiction and Mental Health

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic Questionnaire	Demographic Questionnaire will be used to assess baseline demographics including age, gender, self-reported sex, marital status, smoking status, employment status, education and monthly income.	Baseline
Secondary	Young Mania Rating Scale	Young Mania Rating Scale (YMRS) will be used to assess manic symptom severity. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.	Change in scores from baseline to months 3, 6, and 12
Secondary	Hamilton Depression Rating Scale	Hamilton Depression Rating Scale (HDRS-17) is a clinician-administered scale that will be used to measure severity of depression symptoms.	Change in scores from baseline to months 3, 6, and 12
Secondary	Quality of life scale	EuroQol-5D (EQ- 5D) EQ-5D will be used to assess health-related quality of life over 5 dimensions (mobility, self-care, daily activities, pain-discomfort, anxiety and depression) 44. It also includes and a Visual Analogue Scale that evaluates patients' perceived health status.	Change in scores from baseline to months 3, 6, and 12
Secondary	Bipolar Recovery Questionnaire	Bipolar Recovery Questionnaire (BRQ) is a 36-item questionnaire that will be used to measure functioning and personal experiences of recovery specific to patients with BD.	Change in scores from baseline to months 3, 6, and 12
Secondary	Morisky Medication Adherence Scale-4 items	Morisky Medication Adherence Scale-4-item will be used to measure medication adherence.	Change in scores from baseline to months 3, 6, and 12
Secondary	Bipolar Knowledge and Attitudes Questionnaire	Bipolar Knowledge and Attitudes Questionnaire (BKAQ) is a 25-item questionnaire developed for use in primary care to assess knowledge and attitudes towards bipolar disorder.	Change in scores from baseline to months 3, 6, and 12
Secondary	Client Service Receipt Inventory	Client Service Receipt Inventory (CSRI) is a tool used to collect information on the whole range of services and supports study participants may be accessing.	From baseline to months 3, 6, and 12