Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01242735
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2010-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-21', 'studyFirstSubmitDate': '2010-11-16', 'studyFirstSubmitQcDate': '2010-11-16', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)', 'timeFrame': '15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obsessive Compulsive Disorder', 'OCD', 'Exercise', 'Aerobic Exercise'], 'conditions': ['Obsessive Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '37330252', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are between 18 and 65 years of age\n2. are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months\n3. 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\n4. 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)\n5. have Y-BOCS score greater than 16\n\nExclusion Criteria:\n\n1. DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence\n2. DSM-IV diagnosis of anorexia or bulimia nervosa\n3. DSM-IV diagnosis of bipolar disorder\n4. history of psychotic disorder or current psychotic symptoms\n5. current suicidality or homicidality\n6. marked organic impairment\n7. physical or medical problems that would not allow for safe exercise participation\n8. current pregnancy or intent to become pregnant during the next 12 weeks'}, 'identificationModule': {'nctId': 'NCT01242735', 'briefTitle': 'Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Testing the Efficacy of an Exercise Intervention for Patients With OCD', 'orgStudyIdInfo': {'id': '1006-001'}, 'secondaryIdInfos': [{'id': '1R01MH086513-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH086513-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '12-week moderate-intensity behavioral exercise intervention (AE)', 'interventionNames': ['Behavioral: Aerobic exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health and Wellness', 'description': '12-week health and wellness education control (HEC)', 'interventionNames': ['Behavioral: Health and Wellness']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'BEHAVIORAL', 'description': '12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.', 'armGroupLabels': ['Exercise']}, {'name': 'Health and Wellness', 'type': 'BEHAVIORAL', 'description': '12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.', 'armGroupLabels': ['Health and Wellness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Ana M Abrantes, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}