Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-04 @ 3:40 AM
Study NCT ID:
NCT03289156
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies for Responding to Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress Reappraisal', 'timeFrame': 'One day', 'description': 'Self-report ratings of appraisal of a lab based stressor as threatening or challenging.'}], 'secondaryOutcomes': [{'measure': 'Psychological Response to Stress', 'timeFrame': 'One day', 'description': 'Self-report ratings of perceived stress, anxiety, and fear in response to a lab based psychosocial stressor.'}, {'measure': 'Physiological Response to Stress', 'timeFrame': 'One day', 'description': 'Heart rate in response to a lab based psychosocial stressor as threatening or challenging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.', 'detailedDescription': 'The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress. Different strategies being examined in this study include exercise and arousal reappraisal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 18 to 35\n* Speaks English fluently\n* Passes the Physical Activity Readiness Questionnaire-Plus\n* Mild to Moderate depression symptoms as measured by the Beck Depression Inventory-II (a score ≥14 but ≤25)\n\nExclusion Criteria:\n\n* Hearing or visually impaired such that it will interfere with ability to participate effectively\n* Currently exercising regularly, defined as exercising at a moderate-intensity more than 2 times a week, for at least 20 minutes each time.'}, 'identificationModule': {'nctId': 'NCT03289156', 'briefTitle': 'Strategies for Responding to Stress', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Strategies for Responding to Stress', 'orgStudyIdInfo': {'id': '2017-05-0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arousal Reappraisal', 'description': 'Brief educational intervention about the stress response and arousal reappraisal', 'interventionNames': ['Behavioral: Arousal Reappraisal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Three 5-minute bouts of aerobic exercise at increasing intensities', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Arousal Reappraisal + Exercise', 'description': 'Brief educational intervention about the stress response and arousal reappraisal followed by three 5-minute bouts of aerobic exercise at increasing intensities with practice applying the arousal reappraisal learned earlier.', 'interventionNames': ['Behavioral: Arousal Reappraisal', 'Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Time-matched rest'}], 'interventions': [{'name': 'Arousal Reappraisal', 'type': 'BEHAVIORAL', 'description': 'Brief readings educating about the stress response and usefulness of arousal reappraisal.', 'armGroupLabels': ['Arousal Reappraisal', 'Arousal Reappraisal + Exercise']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.', 'armGroupLabels': ['Arousal Reappraisal + Exercise', 'Exercise']}]}, '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': 'Jolene Jacquart, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}