Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change

NCT ID: NCT02136953

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-08-30

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.

Conditions

Obsessive-Compulsive Disorder; Cognition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

12-weeks of structured, individual aerobic exercise, 3 times a week, increasing from 15-30 minutes to 30-40 minutes per session.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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.

Cognitive Behavioural Therapy (CBT)

12-weeks of manual-based group CBT, 2 hours per week, 8 participants per group.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioural Therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Exercise and CBT

Combined 12-week Exercise program and CBT.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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.

Cognitive Behavioural Therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Waitlist Condition

12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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.

Intervention Type: BEHAVIORAL

Cognitive Behavioural Therapy (CBT)

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Toronto Metropolitan University

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Neil Rector

Research Scientist, Psychologist, and Director of the Mood and Anxiety Treatment and Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Healthcare Hamilton at McMaster University

Hamilton, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MOP133452

Identifier Type: -

Identifier Source: org_study_id