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

Sponsor

Butler Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01242735

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

51.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Behavioral: Aerobic exercise Behavioral: Health and Wellness	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Testing the Efficacy of an Exercise Intervention for Patients With OCD

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology) [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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