Clinical trial NCT02136953: Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
Official title: An Examination of Structured Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Cognition Disorders
Keywords: Obsessive-Compulsive Disorder
Exercise
Cognitive Behavior Therapy
Cognitive Behavioral Therapy
Treatment Efficacy
Brain-Derived Neurotrophic Factor
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Centre for Addiction and Mental Health
name: McMaster University
name: Toronto Metropolitan University
First posted: 2014-05-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Change from baseline in fitness level as measured by incremental maximal exercise test
timeFrame: Baseline to 12 weeks
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton at McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References: