Clinical trial NCT05453864: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Trauma, Psychological
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility Indicator
timeFrame: From baseline to 12th week (end of intervention)
measure: Acceptability Indicator
timeFrame: From baseline to 12th week (end of intervention)
Secondary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: From baseline to 12th week (end of intervention)
measure: The Brief Posttraumatic Growth Inventory
timeFrame: From baseline to 12th week (end of intervention)
measure: Suicide Attempt and Self-Harm
timeFrame: From baseline to 12th week (end of intervention)
measure: Beck Depression Inventory
timeFrame: From baseline to 12th week (end of intervention)
measure: Beck Hopelessness Scale
timeFrame: From baseline to 12th week (end of intervention)
measure: The Generalised Anxiety Disorder
timeFrame: From baseline to 12th week (end of intervention)
measure: Euro-Qol-5 Dimensions scale
timeFrame: From baseline to 12th week (end of intervention)
measure: Problem Solving Inventory
timeFrame: From baseline to 12th week (end of intervention)
measure: The coping with burns questionnaire
timeFrame: From baseline to 12th week (end of intervention)
measure: Burn Specific Health Scale-Brief
timeFrame: From baseline to 12th week (end of intervention)
Other outcomes:
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