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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05453864
• Other study ID #: SAHAR M- CMAP Plus TFCBT-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: MUQADDAS ASIF
• Phone: 042-35842310
• Email: muqaddas.asif[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psychological Trauma
• Suicidal Ideation
• Trauma, Psychological
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)