An Examination of Structured Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting 2% of the population. Cognitive behavioural therapy (CBT) is considered first line psychological treatment for OCD, but there are a large number of treatment non-responders, and the majority of responders have residual symptoms. Aerobic exercise has shown potential benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This study will examine the additive benefits of a standard 12-week aerobic exercise program to a standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT results in significantly better clinical outcomes compared to either treatment alone or no treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive measures of clinical improvement.
详细描述
This study aims to determine if a standard, evidence-based 12-week aerobic exercise program results in significant reduction of obsessive-compulsive symptom severity and associated cognitive dysfunction as a stand-alone intervention and when combined with the first-line psychological treatment, cognitive behavioural therapy (CBT). There are 3 broad aims to this study: 1) to compare the relative efficacy of Exercise, CBT, and their combination (CBT+Ex) versus a non-treatment waitlist control (WL), 2) to examine the extent to which neuropsychological features of OCD improve following treatments, and 3) to determine the extent to which the BDNF gene and protein are a) associated with learning and cognitive factors, and b) moderate symptom and cognitive change across treatments.
The study design allows for a novel, well-powered and potentially landmark study on the impact of exercise on obsessive-compulsive symptom severity and cognitive functioning in OCD, both as a stand-alone treatment and when augmenting CBT. If this study can demonstrate that a short aerobic exercise program of 12 weeks duration can confer significant clinical gains for those suffering with OCD, then it could easily be translated into highly accessible, routine clinical care. Further, demonstration of improvement in OCD-associated cognitive dysfunction, given the refractory nature of the illness, would provide another avenue into the long-term enhancement of outcomes for this chronically affected population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (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
- •Presenting with DSM-5 diagnosed OCD
- •Score of >16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
- •A Physical Activity Readiness Questionnaire (PAR-Q) score of ≤1
- •If on medications for OCD, must be stabilized, i.e. are currently receiving an adequate dose (equivalent of 40mg/day of fluoxetine) for an adequate duration (at least 12 weeks of treatment) prior to the initiation of the study
- •Has physician letter of approval for safe participation in fitness assessment and exercise protocol
排除标准
- •Previous course of CBT treatment (≥ 8 sessions) in past two years
- •Engaging in an active exercise regimen (>2 days/wk of moderate-to-vigorous exercise training) at the time of recruitment
- •Concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
- •Suspected organic pathology
- •Active comorbid medical condition that may require urgent intervention during the treatment
- •Incapable of providing informed consent
研究组 & 干预措施
Exercise and CBT
Combined 12-week Exercise program and CBT.
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
Exercise
12-weeks of structured, individual aerobic exercise, 3 times a week, increasing from 15-30 minutes to 30-40 minutes per session.
干预措施: Exercise (Behavioral)
Cognitive Behavioural Therapy (CBT)
12-weeks of manual-based group CBT, 2 hours per week, 8 participants per group.
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
Exercise and CBT
Combined 12-week Exercise program and CBT.
干预措施: Exercise (Behavioral)
Waitlist Condition
12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.
结局指标
主要结局
Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Baseline and 12 weeks
OCD symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS).The YBOCS is a standardized rating scale measuring 10 items pertaining to obsessions and compulsions on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Both the self-report and clinician interview versions of the YBOCS have been shown to possess high internal consistency and validity.
次要结局
- Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery(Baseline to 12 weeks)
研究者
Dr. Neil Rector
Research Scientist, Psychologist, and Director of the Mood and Anxiety Treatment and Research Program
Sunnybrook Health Sciences Centre