Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)

July 21, 2015 updated by: Butler Hospital

Testing the Efficacy of an Exercise Intervention for Patients With OCD

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing symptoms. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in managing the effects of OCD. If moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage obsessions and compulsions, this will establish that aerobic exercise may be a valuable adjunct to other OCD treatments such as medication and therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. are between 18 and 65 years of age
  2. are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months
  3. currently engaged in at least 12 weeks of stable dose pharmacotherapy and/or are currently engaged in cognitive-behavioral therapy for the past 13 weeks
  4. meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for OCD as assessed by the Structured Clinical Interview for DSM Disorders, Patient Version (SCID-P)
  5. have Y-BOCS score greater than 16

Exclusion Criteria:

  1. DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence
  2. DSM-IV diagnosis of anorexia or bulimia nervosa
  3. DSM-IV diagnosis of bipolar disorder
  4. history of psychotic disorder or current psychotic symptoms
  5. current suicidality or homicidality
  6. marked organic impairment
  7. physical or medical problems that would not allow for safe exercise participation
  8. current pregnancy or intent to become pregnant during the next 12 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise
12-week moderate-intensity behavioral exercise intervention (AE)
Behavioral: Aerobic exercise
12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.
ACTIVE_COMPARATOR: Health and Wellness
12-week health and wellness education control (HEC)
Behavioral: Health and Wellness
12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

November 16, 2010

First Submitted That Met QC Criteria

November 16, 2010

First Posted (ESTIMATE)

November 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1006-001
  • 1R01MH086513-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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