Randomized Controlled Meditation Trial for Treating OCD Comparing Kundalini Yoga Meditation Versus the Relaxation Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
The trial objective is to compare two very different meditation protocols (Kundalini Yoga and Relaxation Response meditation techniques) to help the OCD treatment.
详细描述
The proposed trial comparing the two different meditation protocols is expected to have two phases: 0-month to 4.5-month period where we compare the Kundalini Yoga protocol with Relaxation Response meditation technique, both on the primary efficacy variable using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and some if not most of the secondary variables using The Dimensional Yale-Brown Obsessive Compulsive Scale (DY-BOCS), Clinical Global Impressions (CGI), Profile of Mood States (POMS), Beck Anxiety Inventory (Beck-A), Beck Depression Inventory (Beck-D), and SF-36 Health Status Questionnaire (SF36). Participants will go to the hospital once a week for a 1,5 hour meditation class.After 4.5-months, all patients will be evaluated and merged together into a single group. Patients will then receive 09 to 12 more months of the meditation protocol. The investigators are expecting to recruit 50 to 60 patients to start. Patients will be blinded to the content of the protocol in the other group at baseline and until one group shows greater efficacy on the primary efficacy variable. The intake physician will be blinded to the treatment groups of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Clinical diagnosis of OCD for at least 6 months.
- •A minimum score of 16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) for the 10-item total score at the baseline screening will be required.
- •The patient must sign and been provided with a copy of an Assent Form for their reference.
排除标准
- •Psychoactive prescription medications other than those prescribed for OCD.
- •Spinal problems, or other physically limiting problems.
- •Clinical diagnosis of hypertension, or other cardiovascular problems.
- •Clinical diagnosis of Parkinson's disease.
- •Clinical diagnosis of major depressive disorder with psychotic features, schizophrenia, bipolar disorder, mental retardation, anorexia nervosa, bulimia nervosa, autistic disorder, Asperger's disorder and other forms of pervasive developmental disorder, or traumatic brain.
- •Clinical diagnosis of Tourette's Syndrome.
- •Patients without regular and reliable transportation to the study site.
- •Patients who choose not to participate in meditation and/or chanting (out loud or silently) for personal or religious reasons.
研究组 & 干预措施
Kundalini Yoga Meditation
Kundalini Yoga Meditation is going to be use as therapy for OCD, and it will be compare with Relaxation Response Meditation.
干预措施: Kundalini Yoga Meditation (Behavioral)
Relaxation Response Meditation
Relaxation Response Meditation is going to be use as therapy for OCD, and it will be compare with Kundalini Yoga Meditation.
干预措施: Relaxation Response Meditation (Behavioral)
结局指标
主要结局
The Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Up to 16 months
The Yale-Brown Obsessive Compulsive Scale, sometimes referred to as Y-BOCS, is a test to rate the severity of obsessive-compulsive disorder (OCD) symptoms.
次要结局
- The Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS)(Up to 16 months)
- Clinical Global Impressions (CGI)(Up to 16 months)
- Profile of Mood States (POMS)(Up to 16 months)
- Beck Anxiety Inventory (Beck-A)(Up to 16 months)
- Beck Depression Inventory (Beck-D)(Up to 16 months)
- SF-36 Health Status Questionnaire (SF36)(Up to 16 months)
研究者
Euripedes C. Miguel
Chairmain of psychiatry Departament of University os Sao Paulo
University of Sao Paulo