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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Trauma, Psychological
• Intervention / Treatment: Behavioral: CMAP Plus TFCBT

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUQADDAS ASIF; Phone Number: 042-35842310; Email: muqaddas.asif@pill.org.pk
• Study Contact Backup: Name: Nasim Chaudhry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMAP Plus TFCBT; 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).	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.
No Intervention: Treatment As Usual (TAU); This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Indicator	The feasibility will be determined by collating data on recruitment and retention rates. The success criterion of feasibility will be to recruit > 50% of eligible participants and retain 70% of participants.	From baseline to 12th week (end of intervention)
Acceptability Indicator	Intervention acceptability will be assessed using data on attendance. The criterion for acceptability is a mean attendance rate of >70% of sessions. This will also be determined by participant's views on acceptability of intervention content, mode of delivery etc. thorough qualitative interviews.	From baseline to 12th week (end of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Scale for Suicide Ideation	This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and specificity of a patient's thoughts to kill him/herself during the past week.	From baseline to 12th week (end of intervention)
The Brief Posttraumatic Growth Inventory	This is a 21-item measure of growth that uses a 6-point Likert-type response scale. It helps to assess individual's growth by using retrospective self-reported items.	From baseline to 12th week (end of intervention)
Suicide Attempt and Self-Harm	This consists of four questions measuring the previous suicide attempt and the presence of self-harm. The scale was taken from the original Self-Harm Questionnaire	From baseline to 12th week (end of intervention)
Beck Depression Inventory	This is 21-items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.	From baseline to 12th week (end of intervention)
Beck Hopelessness Scale	This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.	From baseline to 12th week (end of intervention)
The Generalised Anxiety Disorder	This is a 0-3 point rating scale with seven-items to assess common anxiety symptoms of generalised anxiety, panic, social anxiety, and PTSD.	From baseline to 12th week (end of intervention)
Euro-Qol-5 Dimensions scale	It's a standardised instrument to measure participants' health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression)	From baseline to 12th week (end of intervention)
Problem Solving Inventory	This is one of the most widely used self-report inventories in problem solving.	From baseline to 12th week (end of intervention)
The coping with burns questionnaire	This scale is to measure coping after discharge from burns unit. Most items in this scale are burn-related and alluded to specific difficulties that burn patients might experience.	From baseline to 12th week (end of intervention)
Burn Specific Health Scale-Brief	The Burn Specific Health Scale (BSHS) assess burn specific health status of participants.	From baseline to 12th week (end of intervention)

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Stress Disorders, Traumatic; Suicide; Wounds and Injuries; Suicidal Ideation; Psychological Trauma
• Other Study ID Numbers: SAHAR M- CMAP Plus TFCBT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No