Clinical trial NCT05223959: Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Official title: Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2022-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Longitudinal Interval Follow-up Evaluation
timeFrame: Change in scores from baseline to months 3, 6, and 12
Secondary outcomes:
measure: Demographic Questionnaire
timeFrame: Baseline
measure: Young Mania Rating Scale
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Hamilton Depression Rating Scale
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Quality of life scale
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Bipolar Recovery Questionnaire
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Morisky Medication Adherence Scale-4 items
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Bipolar Knowledge and Attitudes Questionnaire
timeFrame: Change in scores from baseline to months 3, 6, and 12
measure: Client Service Receipt Inventory
timeFrame: From baseline to months 3, 6, and 12
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital
state: Select An Option…
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Muhammad Ishrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References: