Culturally Adapted Manually Assisted Brief Problem-Solving Interventions Plus Trauma-focused Cognitive Behavior Therapy (CMAP Plus TF-CBT) for Suicidal Ideation Among Burn Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Acceptability Indicator
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to provide consent due to severe mental or physical illness
- •Unlikely to be available for outcome assessments (temporary residence)
结局指标
主要结局
Acceptability Indicator
时间窗: 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
时间窗: 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.
次要结局
- 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))