Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 4:30 PM
Study NCT ID:
NCT05223959
Status:
RECRUITING
Last Update Posted:
2022-09-26
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Sponsor:
Pakistan Institute of Living and Learning
Organization:
Study Overview
Official Title:
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaPE
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: