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

This study is currently recruiting participants.
Verified August 2012 by Butler Hospital
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT01242735
First received: November 16, 2010
Last updated: August 2, 2012
Last verified: August 2012
History of Changes

November 16, 2010
August 2, 2012
November 2010
March 2013   (final data collection date for primary outcome measure)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Severity of obsessions and compulsions via Y-BOCS interview [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01242735 on ClinicalTrials.gov Archive Site
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Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • Behavioral: Aerobic exercise
    12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.
  • 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.
  • Experimental: Exercise
    12-week moderate-intensity behavioral exercise intervention (AE)
    Intervention: Behavioral: Aerobic exercise
  • Active Comparator: Health and Wellness
    12-week health and wellness education control (HEC)
    Intervention: Behavioral: Health and Wellness
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
March 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Ana M Abrantes, Ph.D. 401-455-6440 Ana_Abrantes@brown.edu
Contact: Julie A Gutierres, M.S. 401-455-6219 jgutierres@butler.org
United States
 
NCT01242735
1006-001, 1R01MH086513-01A1
Yes
Butler Hospital
Butler Hospital
National Institute of Mental Health (NIMH)
Principal Investigator: Ana M Abrantes, Ph.D. Butler Hospital
Butler Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP