Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
Condition: Obsessive-Compulsive Disorder; Cognition Disorders
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Cognition Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Exercise; Cognitive Behavioural Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 weeks of structured aerobic exercise, 3 times a week, following a two-stage graduated regimen: 1) Initial stage (weeks 1-4): 40-60% intensity, 15-30 min duration (+ 5 min warm-up/cool-down), and 2) Improvement stage (weeks 5-12): 60-80% intensity, 30-45 min duration. Adherence measures include self-reported exercise session logs and weekly phone checks by research assistants.; CBT will be delivered in group format, 2 hours per week, for 12 consecutive weeks with 8-10 participants per group and will be conducted according to a session-by-session treatment manual that incorporates Exposure and Response Prevention (ERP) in the early phases of treatment and then increases emphasis on cognitive approaches for obsessions and compulsions outlined in step-by-step strategies.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Exercise; Cognitive Behavior Therapy; Cognitive Behavioral Therapy; Treatment Efficacy; Brain-Derived Neurotrophic Factor