NCT01242735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

4.3 years

First QC Date

November 16, 2010

Last Update Submit

July 21, 2015

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive DisorderOCDExerciseAerobic Exercise

Outcome Measures

Primary Outcomes (1)

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

    15 months

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Aerobic exercise

Health and Wellness

ACTIVE COMPARATOR

12-week health and wellness education control (HEC)

Behavioral: Health and Wellness

Interventions

Aerobic exerciseBEHAVIORAL

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

Exercise
Health and WellnessBEHAVIORAL

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

Health and Wellness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Szuhany KL, Steinberg MH, McLaughlin NCR, Mancebo MC, Brown RA, Greenberg BD, Simon NM, Abrantes AM. Predictors of Long-Term Exercise Engagement in Patients With Obsessive-Compulsive Disorder: The Role of Physical Activity Enjoyment. Behav Ther. 2023 Jul;54(4):610-622. doi: 10.1016/j.beth.2022.12.010. Epub 2023 Jan 5.

    PMID: 37330252DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive DisorderMotor Activity

Interventions

ExerciseHealth

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPopulation Characteristics

Study Officials

  • Ana M Abrantes, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

US(1)