Culturally Adapted Manually Assisted Brief Problem-Solving Interventions Plus Trauma-focused Cognitive Behavior Therapy (CMAP Plus TF-CBT) for Suicidal Ideation Among Burn Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
- Primary Endpoint
- Acceptability Indicator
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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).
Intervention: CMAP Plus TFCBT (Behavioral)
Treatment As Usual (TAU)
This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.
Outcomes
Primary Outcomes
Acceptability Indicator
Time Frame: From baseline to 12th week (end of intervention)
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.
Feasibility Indicator
Time Frame: From baseline to 12th week (end of intervention)
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.
Secondary Outcomes
- Suicide Attempt and Self-Harm(From baseline to 12th week (end of intervention))
- The Generalised Anxiety Disorder(From baseline to 12th week (end of intervention))
- Beck Scale for Suicide Ideation(From baseline to 12th week (end of intervention))
- Beck Hopelessness Scale(From baseline to 12th week (end of intervention))
- The coping with burns questionnaire(From baseline to 12th week (end of intervention))
- The Brief Posttraumatic Growth Inventory(From baseline to 12th week (end of intervention))
- Problem Solving Inventory(From baseline to 12th week (end of intervention))
- Burn Specific Health Scale-Brief(From baseline to 12th week (end of intervention))
- Beck Depression Inventory(From baseline to 12th week (end of intervention))
- Euro-Qol-5 Dimensions scale(From baseline to 12th week (end of intervention))