Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03793569
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2018-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control group and intervention group. Intervention group will participate in peer discussion group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-20', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of development of postpartum depression', 'timeFrame': '4-8 weeks postpartum', 'description': 'Edinburg Postnatal Depression Scale. Score 0-30. Score \\> or = 10 considered greater risk of depression.'}, {'measure': 'Development of postpartum depression', 'timeFrame': '12 weeks postpartum', 'description': 'Edinburg Postnatal Depression Scale. Score 0-30. Score \\> or = 10 considered greater risk of depression.'}, {'measure': 'Development of postpartum depression', 'timeFrame': '6 months postpartum', 'description': 'Edinburg Postnatal Depression Scale. Score 0-30. Score \\> or = 10 considered greater risk of depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this study is to validate a simple and inexpensive intervention to reduce the incidence and impact of Postpartum Depression (PPD). The central hypothesis is that enhancing social support of new mothers specifically via an organized peer get-together will decrease rates of postpartum depression. The rationale for the proposed research is that even though PPD is common and risk factors for developing PPD are known, simple and inexpensive interventions to prevent PPD need to be studied. Postpartum mothers will be recruited for the study and randomized into control versus intervention group. The intervention group will be placed in a peer discussion group. Incidence of PPD will be tracked.', 'detailedDescription': 'According to a 2014 Cochrane Review, postpartum depression (PPD) is present in 13% of new mothers by twelve weeks postpartum. Infant feeding, sleep routines, growth, and socioemotional and cognitive development can be adversely affected by maternal PPD. These negative effects can last into childhood. Previous studies have shown that strong social support is protective against PPD. The 2014 Cochrane Review on this topic comments that simple, inexpensive interventions to decrease rates of PPD are needed and that interventions led by lay-people and done in groups may be helpful to decrease rates of PPD. More recent studies focus on interventions for mothers already showing symptoms of postpartum depression, not on preventing these symptoms from developing.\n\nThe proposed work is important, because it capitalizes on recommendations for future research from the 2014 Cochrane Review on Psychosocial and Psychological Interventions for Preventing Postpartum Depression. The proposed work is also innovative, because it involves a preventive intervention from lay-people in a group setting, with new moms benefiting from each other. At the completion of this project, it is our expectation that mothers in the intervention group will have sustained decreased rates of PPD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women who deliver at the Hershey Medical Center\n2. Postpartum women within first week after delivery\n3. Women who are 18 years of age or older\n\nExclusion Criteria:\n\n1. Postpartum women who delivered newborn before 35 0/7 gestational age.\n2. Postpartum women whose newborn required any length of stay in the newborn intensive care unit.\n3. Postpartum women who do not speak English.\n4. Postpartum women who are less than 18 years old.\n5. Postpartum women who are unable to provide consent.\n6. Postpartum women who were on antidepressant or antianxiety medication or undergoing therapy for depression or anxiety during pregnancy or during postpartum hospitalization.'}, 'identificationModule': {'nctId': 'NCT03793569', 'briefTitle': 'Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?', 'orgStudyIdInfo': {'id': 'STUDY00007890'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.', 'interventionNames': ['Behavioral: Peer discussion group']}], 'interventions': [{'name': 'Peer discussion group', 'type': 'BEHAVIORAL', 'description': 'Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Brittany A Massare, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brittany Massare', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}