Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00307320
Status:
UNKNOWN
Last Update Posted:
2009-12-30
First Post:
2006-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Examining Stress During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-29', 'studyFirstSubmitDate': '2006-03-24', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2009-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['pregnancy', 'stress', 'anxiety'], 'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': "Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant", 'detailedDescription': 'Participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. Participants will also be asked to provide samples of saliva a few times during 1 day. These tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum\n\nA stress-reduction workshop will be offered to all participants at the completion of the study.\n\nParticipants will be paid for study completion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* beginning of the 2nd trimester of pregnancy\n* feel stressed or overwhelmed\n* do not yet have any children\n\nExclusion Criteria:\n\n* more than 1 miscarriage\n* currently receiving medication for anxiety or depression'}, 'identificationModule': {'nctId': 'NCT00307320', 'briefTitle': 'Study Examining Stress During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Coping With Stress During Pregnancy', 'orgStudyIdInfo': {'id': 'HIC 12234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Relaxation techniques', 'interventionNames': ['Behavioral: Relaxation Training']}], 'interventions': [{'name': 'Relaxation Training', 'type': 'BEHAVIORAL', 'description': 'Relaxation techniques training', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia, Department of Psychology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Andrea Chambers, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Virginia / University of Arizona'}, {'name': 'Susan Kirk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arizona', 'class': 'OTHER'}]}}}