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

Primary Purpose

Obsessive Compulsive Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aerobic exercise

Health and Wellness

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, OCD, Exercise, Aerobic Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Health and Wellness

Arm Description

12-week moderate-intensity behavioral exercise intervention (AE)

12-week health and wellness education control (HEC)

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)

Secondary Outcome Measures

Full Information

NCT ID

NCT01242735

First Posted

November 16, 2010

Last Updated

July 21, 2015

Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01242735

Brief Title

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

Official Title

Testing the Efficacy of an Exercise Intervention for Patients With OCD

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder, OCD, Exercise, Aerobic Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

12-week moderate-intensity behavioral exercise intervention (AE)

Arm Title

Health and Wellness

Arm Type

Active Comparator

Arm Description

12-week health and wellness education control (HEC)

Intervention Type

Behavioral

Intervention Name(s)

Aerobic exercise

Intervention Description

12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.

Intervention Type

Behavioral

Intervention Name(s)

Health and Wellness

Intervention Description

12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.

Primary Outcome Measure Information:

Title

Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana M Abrantes, Ph.D.

Organizational Affiliation

Butler Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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