Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-28 @ 3:13 AM
Study NCT ID:
NCT00604604
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2008-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Depression Prevention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 702}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structured Clinical Interview for DSM-IV (SCID-I); Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': '12 weeks postpartum'}], 'secondaryOutcomes': [{'measure': 'State Anxiety Inventory (STAI); UCLA Loneliness Scale; Maternal Health Service Utilization and Cost of Care Questionnaire; Peer Support Evaluation Inventory; Peer Volunteer Experience Questionnaire; Peer Volunteer Activity Log', 'timeFrame': '12 and 24 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of peer (mother-to-mother) support on the prevention of postpartum depression among mothers identified as high-risk.', 'detailedDescription': 'Many new mothers from diverse cultures experience postpartum depression (PPD), a serious form of maternal morbidity with well documented health consequences for the mother, child, and family. While the cause of PPD remains unclear, research consistently demonstrates the importance of psychosocial variables. The purpose of this randomized controlled trial is to evaluate the effect of peer (mother-to-mother) support on the prevention of PPD among mothers identified as high-risk. Public health nurses using the Edinburgh Postnatal Depression Scale (EPDS) screened mothers who were less than 2 weeks postpartum in the regions of Toronto, Peel, Halton, York, Windsor, Sudbury, and Ottawa. Eligible and consenting mothers were randomized to either a control group (usual postpartum care) or experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session). Diverse study outcomes, including depressive symptomatology and health service utilization, were assessed at 12 and 24 weeks postpartum. The results from this trial will make substantive contributions in six areas: (1) develop the body of knowledge concerning the effectiveness of peer support in the prevention of PPD among at-risk mothers; (2) advance our understanding of the advantages and disadvantages of using peer volunteers as a complementary form of health care; (3) provide an economic evaluation of a peer support intervention; (4) offer a detailed analysis of peer support interactions including supportive functions provided, types of relationships developed, and health benefits perceived; (5) investigate the utility of screening at-risk mothers using the EPDS in general public health nursing practice; and (6) present valuable information regarding PPD among a multicultural Canadian population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* live birth\n* discharged from hospital\n* \\<2 weeks postpartum\n* scored \\>9 on the EPDS\n* availability of a peer volunteer who speaks the potential participant's language\n\nExclusion Criteria:\n\n* infant not discharged home with mother\n* current use of anti-depressant or anti-psychotic medication\n* prior self-reported mental illness, including prior PPD, will NOT be an exclusion criterion"}, 'identificationModule': {'nctId': 'NCT00604604', 'briefTitle': 'Postpartum Depression Prevention Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'An RCT to Evaluate the Effectiveness of Peer (Mother-to-Mother) Support for the Prevention of Postpartum Depression', 'orgStudyIdInfo': {'id': 'MCT-66874'}, 'secondaryIdInfos': [{'id': 'ISRCTN68337727'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Control group (usual postpartum care)'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Experimental group (usual postpartum care plus telephone-based support from an experienced mother who has participated in a 4-hour training session)', 'interventionNames': ['Behavioral: Peer support']}], 'interventions': [{'name': 'Peer support', 'type': 'BEHAVIORAL', 'otherNames': ['Mother-to-mother support'], 'description': 'Mothers allocated to the peer support group had access to all of the standard community postpartum services in addition to having received telephone-based support from a peer volunteer (a mother who has previously experienced, and recovered from, postpartum depression and has participated in a 4-hour training session). Telephone contact with a new mother was initiated within 48 to 72 hours of trial enrolment and then as frequently as the dyad deemed necessary; a minimum of four contacts were required.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P3E 3A3', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sudbury & District Health Unit', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L5R 4B2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Peel Health Department', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L6M 3L1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Halton Region Health Department', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'K2G 6J8', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Public Health', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L4B 4N7', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York Region Health Services', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'M2N 5V7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Public Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N9J 4J8', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Essex County Health Unit', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'Cindy-Lee Dennis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr. Cindy-Lee Dennis', 'oldOrganization': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto'}}}}