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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
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

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

    First Posted
    July 7, 2022
    Last Updated
    August 25, 2023
    Sponsor
    Pakistan Institute of Living and Learning
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    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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