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

Study Overview
=================
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.

Official Title
-----------------
Testing the Efficacy of an Exercise Intervention for Patients With OCD

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Behavioral: Aerobic exercise
* Behavioral: Health and Wellness


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>12-week moderate-intensity behavioral exercise intervention (AE) | Behavioral: Aerobic exercise<br>* 12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.<br>|
| Active Comparator: Health and Wellness<br>12-week health and wellness education control (HEC) | Behavioral: Health and Wellness<br>* 12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology) |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive Compulsive Disorder, OCD, Exercise, Aerobic Exercise