Culturally Adapted Manual Assisted Cognitive Behavioral Therapy for Prevention of Self Harm: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 4
- 主要终点
- Beck scale for suicidal ideation
研究概览
简要总结
Aim:
To adapt and develop a culturally appropriate psychological intervention and test its feasibility, and acceptability for the patients presenting to general hospital following self-harm in Karachi Pakistan.
Primary hypothesis:
Patients who receive cognitive behavioral therapy will show significant decrease in suicidal ideation as compared to patients with treatment as usual.
Design:
Randomized Control Trial
Setting:
Medical Departments of General Hospitals in Karachi.
Participants:
A total of 200 self harm patients will be randomized to psychological intervention and treatment as usual arm.
Intervention:
Culturally Adapted Cognitive Behavioral Therapy (CBT)
Outcome measure:
Beck Suicidal Ideation Scale
详细描述
Culturally Adapted manualised Cognitive Behavioral Therapy (CBT) will be a brief problem focused therapy comprising of 6 sessions within three months after a self-harm episode. The adapted therapy/training will be delivered by therapists/trained counselors at the hospital. Sessions will be offered weekly in the first two weeks and than fortnightly and will last 50 minutes. During each session the therapists will assess the risk of suicide and will liaise with the research supervisor and patient's treating clinician.
The areas covered by the manual which has been adapted include an evaluation of the self-harm attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions and negative thinking and relapse prevention strategies. The treatment will be structured around patient's current problems with the relevant sections of the manual helping the patient to deal with specific problems leading to the self-harm act. Between the sessions the manual can be used for homework tasks by the patient.
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
- 16 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An episode of self harm within 48 hours before being admitted at the department;
- •age of 16 to 64 years;
- •Resident in the trial site catchments area,
- •Ability to complete a baseline assessment;
- •Ability to provide at least 2 verifiable contacts to improve tracking for subsequent assessments; and ability to understand and provide informed consent.
排除标准
- •• A medical disorder that would prevent participation in an outpatient clinical trial.
- •Temporary resident unlikely to be available for follow up.
- •Diagnosis of Alcohol and other drug dependence, schizophrenia or Bipolar Disorders.
研究组 & 干预措施
Control
Patients who will be randomized to the "treatment as usual" arm will receive routine care
Experimental Arm
Culturally Adapted Manualised Cognitive Behavioral Therapy (CBT) Sessions will be offered weekly in the first month and then fortnightly.
干预措施: Other (Other)
结局指标
主要结局
Beck scale for suicidal ideation
时间窗: six months
This is a 19 item instrument which measures the intensity, duration, and specificity of a patient's thoughts about committing suicide.
次要结局
- Quality of life (EQ 5 D)(six months)
- Coping Resource Inventory (CRI)(six months)
- Para suicide history: interview(six months)
- Hopelessness ( Beck hopelessness scale)(six months)
- Beck Depression Inventory(six months)
- PSI/SF(six months)
- CSRI Health care use Questionnaire(six months)