Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 1:17 PM
Study NCT ID:
NCT02361203
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2015-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Virtual Reality Exposure Therapy for Acrophobia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000719188', 'term': 'Acrophobia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-02-05', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear scores', 'timeFrame': '7 (+/- 3) days after exposure therapy', 'description': 'Change in fear scores using subjective units of distress will be assessed.'}, {'measure': 'Perceived threat likelihood scores', 'timeFrame': '7 (+/- 3) days after exposure therapy', 'description': 'Change in the perception of threat likelihood on a scale from 1-5 will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Skin conductance fluctuations', 'timeFrame': '7 (+/- 3) days after exposure therapy', 'description': 'Changes in skin conductance fluctuations will be assessed.'}, {'measure': 'Heart rate fluctuations', 'timeFrame': '7 (+/- 3) days after exposure therapy', 'description': 'Heart rate fluctuations will be assessed.'}, {'measure': 'Acrophobia Severity', 'timeFrame': '14 (+/- 3) days after exposure therapy', 'description': 'Change in score on the Acrophobia Questionnaire'}, {'measure': 'Attitudes Toward Heights', 'timeFrame': '14 (+/- 3) days after exposure therapy', 'description': 'Change in score on the Attitudes Toward Heights Inventory'}, {'measure': 'Clinical Global Improvement', 'timeFrame': '14 (+/- 3) days after exposure therapy', 'description': 'Change in score on the Clinical Global Improvement Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fear of Heights']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 25\n* Speaks English fluently\n* Score of 80 or higher on the Acrophobia Questionnaire\n* SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear\n* Passes the Physical Activity Readiness Questionnaire-Plus\n\nExclusion Criteria:\n\n* Hearing or visually impaired\n* Currently receiving exposure-based treatment for acrophobia\n* Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating \\< 50'}, 'identificationModule': {'nctId': 'NCT02361203', 'briefTitle': 'Exercise and Virtual Reality Exposure Therapy for Acrophobia', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Exercise and Virtual Reality Exposure Therapy for Acrophobia', 'orgStudyIdInfo': {'id': '2014-12-0037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Exercise'}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Pre', 'description': '30 minutes of aerobic exercise before exposure therapy', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': "30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.", 'armGroupLabels': ['Exercise Pre']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Jasper Smits, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Student', 'investigatorFullName': 'Jolene Jacquart', 'investigatorAffiliation': 'University of Texas at Austin'}}}}