Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 901
- 试验地点
- 8
- 主要终点
- Suicide Attempt Self Injury Interview SASII
研究概览
简要总结
To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm
详细描述
Suicide is a serious global public health issue, ranked amongst the leading causes of death in many countries. Most of these (75%) are in the low and middle income countries (LAMIC) and globally suicide is the second leading cause of death in young people 15-29 years of age. There is no official data on suicide from Pakistan, a conservative South Asian Islamic country with historically low suicide rates. Both suicide and attempted suicide are illegal acts, as well as socially and religiously condemned, however, there is accumulating evidence that suicide rates have been gradually increasing in Pakistan over the last few years.
The culturally adapted psychological intervention C-MAP utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice. Our previous pilot trial in Karachi shows the efficacy of CBT based intervention(C-MAP) in people who had recently self harmed.The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients over the age of 18 years will be considered eligible for the study.
- •Participants will have to be living within the catchment area of the participating practices and hospitals.
- •Not needing inpatient psychiatric treatment.
排除标准
- •Temporary resident unlikely to be available for follow up.
- •Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
- •Unable to engage, participate or respond to the research questionnaires.
结局指标
主要结局
Suicide Attempt Self Injury Interview SASII
时间窗: up to 12th months
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)
次要结局
- Beck Scale for Suicidal ideation (BSI).(Baseline, 3, 6, 9 and 12th months)
- Beck Hopelessness Scale(Baseline,3rd,6th,9th and 12th months)
- Beck Depression Inventory (BDI)(Baseline,3rd,6th,9th and 12th months)
- Coping Resource Inventory (CRI).(Baseline,3rd,6th,9th and 12th months)
- Client Satisfaction Questionnaire (CSQ).(Baseline,3rd,6th,9th and 12th months)
- EuroQol-5 Dimensions (EQ5-D)(Baseline,3rd,6th,9th and 12th months)
研究者
Dr. Nusrat Husain
Chief Investigator
University of Manchester
