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

Pakistan Institute of Living and Learning

Status: Not yet enrolling

Conditions: Suicidal Ideation; Trauma, Psychological

Treatments: Behavioral: CMAP Plus TFCBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05453864

SAHAR M- CMAP Plus TFCBT-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 and above
• Had burn injury and identified for having suicidal ideation measures with Beck scale for suicidal Ideation (BSI)
• Able to give informed consent
• Living within the catchment areas of participating hospitals

Exclusion criteria

• Unable to provide consent due to severe mental or physical illness
• Unlikely to be available for outcome assessments (temporary residence)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

CMAP Plus TFCBT

Experimental group

Description:

This intervention is a manual-assisted intervention, which will include two existing culturally adapted psychological interventions 1) Culturally Adapted Manual Assisted Psychological (CMAP), 2) Self-help manual for trauma - BASID Ki Kahani. Both interventions are based on the principles of Cognitive behavioural therapy (CBT).

Treatment:

Behavioral: CMAP Plus TFCBT

Treatment As Usual (TAU)

No Intervention group

Description:

This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.