Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability measures
研究概览
简要总结
This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.
详细描述
Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 to 65 years
- •5 years of education
- •Symptoms of depression and anxiety
排除标准
- •Substance use disorder according to DSM-5 criteria as determined by primary care clinician
- •Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
- •Active psychosis as determined by their primary care clinician
结局指标
主要结局
Feasibility and acceptability measures
时间窗: 12 weeks
Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression
Clinical Measures
时间窗: 12 weeks
Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)
次要结局
未报告次要终点