Evaluating the Use of Mindfulness Meditation Utilizing a Consumer-Grade EEG Biofeedback Device for Patients Awaiting Treatment for Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most efficacious treatment intervention for OCD, there is a growing literature indicating the mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety symptoms as well as reducing relapse risk following treatment.The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.
详细描述
The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups.Outcome measures will involve ratings of OCD symptom severity, OCD beliefs, mindfulness, and use of thought control strategies. At baseline, mid treatment (session 4), and post intervention, participants will complete the Yale-Brown Obsessive Compulsive Scale, Obsessive Compulsive Inventory, Obsessive Beliefs Questionnaire, Five Factor Mindfulness Questionnaire, Thought Control Questionnaire, Acceptance and Action Questionnaire, Mind Wandering Scale and the Metacognitions Questionnaire. Once per week, participants will complete the YBOCS, TCQ, and MW. This weekly data will be collected online using the "Survey Monkey" web portal. Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All inclusion and
排除标准
- •are consistent with the established guidelines for our service - there are no additional study specific criteria. Potential subjects are referred to the service with a query of OCD. Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, the ability to communicate in written and spoken English is an inclusion criterion. disorder
- •Exclusion Criteria:
- •Exclusion criteria include a) those with active substance abuse/dependence, b) suspected organic pathology, c) recent suicide attempt/active suicidality, d) active bipolar, psychotic disorder or post-traumatic stress
研究组 & 干预措施
Mindfulness
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
干预措施: Mindfulness (Device)
Control
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Completed once per week, for eight weeks
A self-report inventory of obsessive compulsive symptoms
次要结局
- Obsessive Beliefs Questionnaire(Completed at three timepoints - week 1, week 4, week 8)
- Thought Control Questionnaire(Completed at three timepoints - week 1, week 4, week 8)
- Acceptance and Action Questionnaire(Completed at three timepoints - week 1, week 4, week 8)
- Metacognitions Questionnaire(Completed at three timepoints - week 1, week 4, week 8)
- Obsessive Compulsive Inventory(Completed at three timepoints - week 1, week 4, week 8)
- Five Factor Mindfulness Questionnaire(Completed at three timepoints - week 1, week 4, week 8)
- Mind Wandering Scale(Completed at three timepoints - week 1, week 4, week 8)