Feasibility and Efficacy Trial of a Culturally Adapted Guided Self-Help CBT Manual for Obsessive-Compulsive Disorder: A Randomised Controlled Study From Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- Clients' satisfaction
研究概览
简要总结
This randomised controlled trial (RCT) aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, guided self-help cognitive behaviour therapy (CBT) manual specifically designed for individuals with OCD in Pakistan.
详细描述
Obsessive-Compulsive Disorder (OCD) is a chronic and debilitating mental health condition characterised by persistent, intrusive thoughts (obsessions) and repetitive behaviours or mental acts (compulsions). These symptoms are often distressing, time-consuming, and cause significant functional impairment and reduction in quality of life. Cognitive and behavioural therapies, particularly the Exposure and Response Prevention (ERP), have consistently demonstrated efficacy as a first-line treatment for OCD. However, access to trained therapists remains limited in low- and middle-income countries (LMICs), including Pakistan.
Self-help interventions rooted in CBT principles, especially when culturally adapted, represent a promising, scalable, and cost-effective alternative to conventional therapy. Previous research in Pakistan has shown the feasibility and acceptability of culturally adapted CBT (CaCBT) in treating depression and OCD within primary care and outpatient settings (Naeem et al., 2011; Aslam et al., 2015).
This randomised controlled trial (RCT) aims to assess the feasibility, acceptability, and preliminary efficacy of a culturally adapted, guided self-help CBT manual specifically designed for individuals with OCD in Pakistan.
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 (Participant)
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
- •Age ≥ 18 years
- •Clinical diagnosis of OCD (with or without comorbid depression)
- •Minimum 5 years of formal education
- •Residing within commuting distance of the participating sites
- •Ability to read and write Urdu
- •Provision of informed written consent
排除标准
- •Current substance use or dependence (diagnosed)
- •Significant cognitive impairment (e.g., dementia or intellectual disability)
- •OCD with active psychosis
结局指标
主要结局
Clients' satisfaction
时间窗: 12 weeks
The client satisfaction scale will be used. At the end of the intervention, researchers will ask participants to describe their experience. They will be asked to name the sessions they found most or least helpful and to provide suggestions for improving the intervention.
Obsessive-compulsive symptoms
时间窗: 12 weeks
As assessed through participants' scores on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Feasibility and acceptability
时间窗: 12 weeks
Feasibility and acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.
Clients' satisfaction
时间窗: 12 weeks
The client satisfaction scale will be used. At the end of the intervention, researchers will ask participants to describe their experience. They will be asked to name the sessions they found most or least helpful and to provide suggestions for improving the intervention.
次要结局
- Anxiety & depression(12 weeks)
- Functionality(12 weeks)