CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors
Primary Purpose
Suicidal Ideation, Trauma, Psychological
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CMAP Plus TFCBT
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CMAP Plus TFCBT
Treatment As Usual (TAU)
Arm 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).
This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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
Beck Depression Inventory
This is 21-items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Beck Hopelessness Scale
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
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.
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)
Problem Solving Inventory
This is one of the most widely used self-report inventories in problem solving.
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.
Burn Specific Health Scale-Brief
The Burn Specific Health Scale (BSHS) assess burn specific health status of participants.
Full Information
NCT ID
NCT05453864
First Posted
July 7, 2022
Last Updated
August 25, 2023
Sponsor
Pakistan Institute of Living and Learning
1. Study Identification
Unique Protocol Identification Number
NCT05453864
Brief Title
CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Trauma, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CMAP Plus TFCBT
Arm Type
Experimental
Arm 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).
Arm Title
Treatment As Usual (TAU)
Arm Type
No Intervention
Arm Description
This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.
Intervention Type
Behavioral
Intervention Name(s)
CMAP Plus TFCBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility Indicator
Description
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.
Time Frame
From baseline to 12th week (end of intervention)
Title
Acceptability Indicator
Description
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.
Time Frame
From baseline to 12th week (end of intervention)
Secondary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation
Description
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.
Time Frame
From baseline to 12th week (end of intervention)
Title
The Brief Posttraumatic Growth Inventory
Description
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.
Time Frame
From baseline to 12th week (end of intervention)
Title
Suicide Attempt and Self-Harm
Description
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
Time Frame
From baseline to 12th week (end of intervention)
Title
Beck Depression Inventory
Description
This is 21-items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Time Frame
From baseline to 12th week (end of intervention)
Title
Beck Hopelessness Scale
Description
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Time Frame
From baseline to 12th week (end of intervention)
Title
The Generalised Anxiety Disorder
Description
This is a 0-3 point rating scale with seven-items to assess common anxiety symptoms of generalised anxiety, panic, social anxiety, and PTSD.
Time Frame
From baseline to 12th week (end of intervention)
Title
Euro-Qol-5 Dimensions scale
Description
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)
Time Frame
From baseline to 12th week (end of intervention)
Title
Problem Solving Inventory
Description
This is one of the most widely used self-report inventories in problem solving.
Time Frame
From baseline to 12th week (end of intervention)
Title
The coping with burns questionnaire
Description
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.
Time Frame
From baseline to 12th week (end of intervention)
Title
Burn Specific Health Scale-Brief
Description
The Burn Specific Health Scale (BSHS) assess burn specific health status of participants.
Time Frame
From baseline to 12th week (end of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MUQADDAS ASIF
Phone
042-35842310
Email
muqaddas.asif@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Nasim Chaudhry
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors
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