Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT00855192
Status:
UNKNOWN
Last Update Posted:
2010-03-18
First Post:
2009-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Relaxation Group for Anxiety and Depression Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-17', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression as measured by Edinburgh Postnatal Depression Scale and anxiety as measured by the State-Trait Anxiety Inventory and the Cambridge Worry Scale', 'timeFrame': 'Participants will be asked to complete the questionnaires before the group commences, at 4 weeks, at the end of the group, and 6 weeks postpartum.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety', 'depression', 'pregnancy', 'antenatal', 'prenatal', 'mindfulness-based therapy', 'interpersonal therapy', 'support groups'], 'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'Approximately 20% of pregnant women experience depression. Untreated depression during pregnancy is linked to decreased prenatal care, difficulties in the pregnancy, poorer outcomes for the baby, and developmental, language, and behaviour problems in the older child.\n\nWhile medication can often offer relief, pregnant women suffering with depression are often reluctant to take medications that may affect the unborn baby. There is little research about the effectiveness of other treatments such as support groups.\n\nThe investigators project will provide relaxation groups for pregnant women with anxiety and depression. The group will provide a chance to get support from other pregnant women. Two health care specialists will provide information about anxiety and depression. They will also teach the skills for women to manage their symptoms. Women will be asked to complete a few questionnaires to evaluate their symptoms before, during, and after they join the group. They will also be asked to evaluate how the group met their needs.', 'detailedDescription': 'Pregnant women between 15-28 weeks, who speak english are invited to join an 8 week group to relieve anxiety and depression.\n\nWe have collected sociodemographic data, as well as social support, life events.\n\nOutcome measures are a decrease in anxiety and depression-as measured by the Edinburgh Postnatal Depression Scale, the Cambridge Worry Scale, and the STAI-Trait Scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 to 28 weeks pregnant and English speaking\n\nExclusion Criteria:\n\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT00855192', 'acronym': 'ARG', 'briefTitle': 'Antenatal Relaxation Group for Anxiety and Depression Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Antenatal Depression Group Research Project: The Effectiveness of Mindfulness-based Relaxation and Interpersonal Therapy to Relieve Anxiety and Depression Symptoms in Pregnant Women.', 'orgStudyIdInfo': {'id': 'Beh #07-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mindfulness-based therapy', 'description': 'mindfulness-based meditation', 'interventionNames': ['Behavioral: mindful meditation']}, {'type': 'EXPERIMENTAL', 'label': 'interpersonal therapy', 'description': 'psycho-educational', 'interventionNames': ['Behavioral: interpersonal therapy']}], 'interventions': [{'name': 'mindful meditation', 'type': 'BEHAVIORAL', 'description': 'interpersonal and psycho-educational', 'armGroupLabels': ['mindfulness-based therapy']}, {'name': 'interpersonal therapy', 'type': 'BEHAVIORAL', 'description': 'psycho-educational', 'armGroupLabels': ['interpersonal therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7K 4A7', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Community Village', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan Department of Psychiatry', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Angela N Bowen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal University Hospital Foundation, Saskatoon, SK, Canada', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Angela Bowen, RN, PhD Assistant Professor, College of Nursing', 'oldOrganization': 'College of Medicine, Department of Psychiatry, University of Saskatchewan'}}}}