Trial record 17 of 36 for:
Obsessive Compulsive Disorder [CONDITION] AND NIH [SPONSOR-COLLABORATORS-CLASS] NOT NIMH [ORGANIZATION-NAME]
Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
This study is currently recruiting participants.
Verified August 2012 by Butler Hospital
Sponsor:
Butler Hospital
Collaborator:
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 |
| Estimated Primary Completion Date: | March 2013 (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:
- are between 18 and 65 years of age
- are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months
- 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
- 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)
- have Y-BOCS score greater than 16
Exclusion Criteria:
- DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence
- DSM-IV diagnosis of anorexia or bulimia nervosa
- DSM-IV diagnosis of bipolar disorder
- history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
- marked organic impairment
- physical or medical problems that would not allow for safe exercise participation
- current pregnancy or intent to become pregnant during the next 12 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242735
Contacts
| 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 |
Locations
| United States, Rhode Island | |
| Butler Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Principal Investigator: Ana M Abrantes, Ph.D. | |
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: | August 2, 2012 |
| 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 June 18, 2013