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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01242735
First received: November 16, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Behavioral: Aerobic exercise
Behavioral: Health and Wellness
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Efficacy of an Exercise Intervention for Patients With OCD

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: November 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242735

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Ana M Abrantes, Ph.D. Butler Hospital
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT01242735     History of Changes
Other Study ID Numbers: 1006-001, 1R01MH086513-01A1
Study First Received: November 16, 2010
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board
United States: National Institute of Mental Health

Keywords provided by Butler Hospital:
Obsessive Compulsive Disorder
OCD
Exercise
Aerobic Exercise

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 20, 2014