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

NCT02136953 | Completed DMC

• 1 other identifier: MOP133452
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

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.

Conditions

Obsessive-Compulsive Disorder; Cognition Disorders

Keywords

Obsessive-Compulsive Disorder; Exercise; Cognitive Behavior Therapy; Cognitive Behavioral Therapy; Treatment Efficacy; Brain-Derived Neurotrophic Factor

Outcome Measures

Primary Outcomes (1)

• Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery

  Baseline to 12 weeks

Other Outcomes (1)

• Change from baseline in fitness level as measured by incremental maximal exercise test

  Baseline to 12 weeks

Study Arms (4)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Cognitive Behavioural Therapy (CBT)

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioural Therapy (CBT)

Exercise and CBT

EXPERIMENTAL

Combined 12-week Exercise program and CBT.

Behavioral: Exercise; Behavioral: Cognitive Behavioural Therapy (CBT)

Waitlist Condition

NO INTERVENTION

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

Interventions

Exercise 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.

Exercise; Exercise and CBT

Cognitive Behavioural Therapy (CBT) 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.

Cognitive Behavioural Therapy (CBT); Exercise and CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre for Addiction and Mental Health: collaborator
• McMaster University: collaborator
• Toronto Metropolitan University: collaborator

Study Sites (3)

St. Joseph's Healthcare Hamilton at McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Cognition Disorders; Motor Activity

Interventions

Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurocognitive Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Psychologist, and Director of the Mood and Anxiety Treatment and Research Program

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: August 30, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

CA (3)