NCT05453864

CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors

Culturally Adapted Manually Assisted Brief Problem-Solving Interventions Plus Trauma-focused Cognitive Behavior Therapy (CMAP Plus TF-CBT) for Suicidal Ideation Among Burn Survivors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Pakistan Institute of Living and Learning · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine whether CMAP Plus TFBCT is feasible and acceptable for burn survivors with suicidal ideations. To identify any barriers to the recruitment of participants. To determine initial data for the primary outcome measure to perform a sample size calculation for a larger trial.

Detailed description

The study will be conducted in two stages. Stage 1 is to adapt the existing CMAP intervention for burn survivors and integrate it with existing culturally adapted TFCBT intervention. Stage 2 is to test the feasibility and acceptability of study intervention in a Randomised Controlled Trial (RCT). In the first stage, the adaptation of the intervention will be carried out by a group of experts including bilingual health experts such as psychiatrists and psychologists, the potential users (i.e., burn survivors with Suicidal ideation), and experienced CBT therapists. The expert group will involve in an iterative process of discussion for the adaptation of the intervention including the development of the integrated intervention manual. Stage 2 will be a rater blind, two-arm, multi-site, feasibility randomized controlled trial (RCT) of CMAP Plus TF CBT for burn survivors with suicidal ideation randomized either to 1) CMAP Plus TF CBT added to Treatment As Usual (TAU) or 2) TAU alone. A total of N=80 burn survivors with suicidal ideation will be recruited from hospitals (Burn Injuries Units) in Karachi, Lahore, Rawalpindi, Quetta, Peshawar, Multan, and Hyderabad, Pakistan. Each participant in the intervention arm will receive 8 individual sessions of CMAP Plus TFCBT over 12 weeks. Assessment measures will be administered before and after the intervention in the 12th week. All assessments will be rater blind. After post-assessments, a purposefully selected subset (stratified by age \& gender) of participants will be invited for qualitative interviews (upto 15) to explore their experiences and satisfaction with the intervention.

Conditions

• Suicidal Ideation
• Trauma, Psychological

Interventions

Type	Name	Description
BEHAVIORAL	CMAP Plus TFCBT	This will include 8 individual sessions of CMAP Plus TFCBT delivered by a trained therapist over a period of 12 weeks. Each session will last between 45 to 60 minutes.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-03-30
• Completion: 2025-09-30
• First posted: 2022-07-12
• Last updated: 2024-05-17