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

Obsessive Compulsive Disorder Clinical Trial

Official title:

Testing the Efficacy of an Exercise Intervention for Patients With OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242735
• Other study ID #: 1006-001
• Secondary ID: 1R01MH086513-01A
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2010
• Last updated: July 21, 2015
• Start date: November 2010
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: National Institute of Mental Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Aerobic exercise
12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.
• Health and Wellness
12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)		15 months	No