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

Primary Purpose

Obsessive-Compulsive Disorder, Cognition Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Cognitive Behavioural Therapy (CBT)
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Exercise, Cognitive Behavior Therapy, Cognitive Behavioral Therapy, Treatment Efficacy, Brain-Derived Neurotrophic Factor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton at McMaster University
  • Sunnybrook Health Sciences Centre
  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

Exercise

Cognitive Behavioural Therapy (CBT)

Exercise and CBT

Waitlist Condition

Arm Description

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

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

Combined 12-week Exercise program and CBT.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery
We have included core paper-and-pencil and computerized tests, such as those from the Cambridge Neuropsychological Test Automated Battery (CANTAB), which tap separable cognitive domains that are sensitive to OCD. CANTAB measures are standardized and have been shown to discriminate amongst many neurological and psychiatric illnesses To avoid practice effects, measures were selected to have either alternate form or to be amenable to calculation of reliable change indices (RCIs). RCIs will be used to determine if neuropsychology performance scores change significantly over time.

Full Information

First Posted
May 9, 2014
Last Updated
October 3, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Centre for Addiction and Mental Health, McMaster University, Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02136953
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Centre for Addiction and Mental Health, McMaster University, Toronto Metropolitan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Cognition Disorders
Keywords
Obsessive-Compulsive Disorder, Exercise, Cognitive Behavior Therapy, Cognitive Behavioral Therapy, Treatment Efficacy, Brain-Derived Neurotrophic Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
12-weeks of structured, individual aerobic exercise, 3 times a week, increasing from 15-30 minutes to 30-40 minutes per session.
Arm Title
Cognitive Behavioural Therapy (CBT)
Arm Type
Active Comparator
Arm Description
12-weeks of manual-based group CBT, 2 hours per week, 8 participants per group.
Arm Title
Exercise and CBT
Arm Type
Experimental
Arm Description
Combined 12-week Exercise program and CBT.
Arm Title
Waitlist Condition
Arm Type
No Intervention
Arm Description
12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery
Description
We have included core paper-and-pencil and computerized tests, such as those from the Cambridge Neuropsychological Test Automated Battery (CANTAB), which tap separable cognitive domains that are sensitive to OCD. CANTAB measures are standardized and have been shown to discriminate amongst many neurological and psychiatric illnesses To avoid practice effects, measures were selected to have either alternate form or to be amenable to calculation of reliable change indices (RCIs). RCIs will be used to determine if neuropsychology performance scores change significantly over time.
Time Frame
Baseline to 12 weeks
Other Pre-specified Outcome Measures:
Title
Change from baseline in fitness level as measured by incremental maximal exercise test
Description
Participants will undergo an incremental maximal exercise test on an electronically braked cycle ergometer (Lode Corival) to establish level of fitness. Peak heart-rate, peak watts, total duration and ratings of perceived exertion are all recorded during the test. Peak heart-rate will also be used to tailor the aerobic Exercise treatment to the individual participant in order to maximize health benefit.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton at McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

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

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