Mindfulness-Based Exposure Group Therapy for Obsessive-compulsive Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Obsessive-compulsive symptoms improvement
研究概览
简要总结
Obessive-Compulsive Disorder (OCD) is frequently treatment-refractory and imposes a substantial burden on affected individuals. Although Exposure and Response Prevention (ERP) is widely regarded as the first-line intervention, its inherently distressing nature contributes to treatment refusal and premature dropout in a subset of patients. The present study aims to develop and validate a novel intervention, Mindfulness-Based Exposure Therapy (MBET).
In contrast to existing protocols that incorporate mindfulness as an adjunct to ERP and have yielded mixed or limited benefits, this study seeks a theoretically grounded integration of mindfulness and exposure-based principles. We hypothesize that mindfulness training improves emotion regulation, thereby producing a synergistic effect that enhances patients' capacity to engage in and complete exposure tasks.
From a clinical perspective, MBET is intended to offer a more tolerable and acceptable alternative to standard ERP, with the potential to improve treatment adherence and clinical outcomes among patients who experience traditional exposure procedures as excessively distressing.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria
- •Are between 16 and 55 years of age (inclusive)
- •Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score ≥ 16
- •Have an education level of junior high school or above
- •Are medication-free or have been stabilized on psychotropic medication for at least 8 weeks
- •Have sufficient visual and auditory capabilities to complete study assessments
- •Are willing to participate and provide written informed consent
排除标准
- •Meet DSM-5 criteria for any other psychiatric disorder besides OCD
- •Have severe OCD symptoms that prevent completion of assessments
- •Exhibit active suicidal ideation or high suicide risk
- •Have a serious somatic disease, central nervous system disease, or substance abuse history
- •Are pregnant, breastfeeding, or planning pregnancy
- •Have metal implants contraindicated for MRI (e.g., pacemakers, intracranial clips, metal dentures, arterial stents, joint fixations)
结局指标
主要结局
Obsessive-compulsive symptoms improvement
时间窗: Pre-treatment (Baseline), Mid-treatment (Week 5), and Post-treatment (Week 10).
The severity of OCD symptoms is assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Obsessive-compulsive symptoms improvement is reflected by Y-BOCS reduction rate.
次要结局
未报告次要终点
研究者
Zhen Wang
Shanghai mental health center
Shanghai Mental Health Center