Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-04-13 @ 10:59 PM
Study NCT ID:
NCT02057627
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-05', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on maternal depression diagnosis immediately following the 3 month intervention and at 3 months post-intervention as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)', 'timeFrame': 'baseline, 3 months (post-intervention) and 6 months (follow-up)'}, {'measure': 'Change from baseline in maternal depressive symptom scores immediately following the 3 month intervention and at 3 months post-intervention as measured by the Edinburgh Postnatal Depression Scale', 'timeFrame': 'baseline, 3 months (post-intervention) and 6 months (follow-up)'}, {'measure': 'Mother-infant interaction (videotaped and coded) immediately following the 3 month intervention and at 3 months post-intervention', 'timeFrame': '3 months (post-intervention) and 6 months (follow-up)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in maternal anxiety diagnosis immediately following the 3 month intervention and at 3 months post-intervention per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)', 'timeFrame': 'baseline, 3 months (post-intervention) and 6 months (follow-up)'}, {'measure': 'Maternal parenting stress immediately following the 3 month intervention and at 3 months post-intervention as measured by the Parenting Stress Index - Short Form (PSI-SF)', 'timeFrame': '3 months (post-intervention) and 6 months (follow-up)'}, {'measure': 'Change from baseline in maternal anxiety symptom level immediately following the 3 month intervention and at 3 months post-intervention as measured by the State-Trait Anxiety Inventory - State (STAI-State)', 'timeFrame': 'baseline, 3 months (post-intervention), 6 months (follow-up)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '23562990', 'type': 'RESULT', 'citation': 'Goodman JH, Guarino AJ, Prager JE. Perinatal dyadic psychotherapy: design, implementation, and acceptability. J Fam Nurs. 2013 Aug;19(3):295-323. doi: 10.1177/1074840713484822. Epub 2013 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'Maternal depression and mother-infant relationship dysfunction have reciprocal effects on each other. An integrated approach addressing both problems simultaneously may improve outcomes. Perinatal Dyadic Psychotherapy (PDP) was developed to prevent/decrease postpartum depression and facilitate optimal mother-infant relationships. The purpose of this pilot study is to determine the feasibility, acceptability, and preliminary efficacy of PDP. Depressed first-time mothers (meeting diagnostic criteria for depression and/or with high depression symptom levels) and their 6-week-old infants will be randomized to receive either the PDP intervention or a control condition. The PDP intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. Control mothers will receive usual care plus depression monitoring by phone. Data will be collected at baseline, post-intervention, and 3 month follow-up. Assessments included maternal depression (diagnosis and severity), maternal anxiety (diagnosis and severity), parenting stress, and mother-infant interaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time, English-speaking mothers of healthy singleton newborns\n* Positive screen (\\> 10) on Edinburgh Postnatal Depression Scale\n\nExclusion Criteria:\n\n* Suicidal ideation\n* Currently receiving depression treatment\n* Meets criteria for bipolar disorder and/or lifetime or current psychotic disorder'}, 'identificationModule': {'nctId': 'NCT02057627', 'briefTitle': 'Mother-Infant Intervention for Postpartum Depression and Associated Mother-Infant Relationship Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Dyadic Intervention for Women at Risk for Postpartum Depression and Their Infants', 'orgStudyIdInfo': {'id': '1R21HD065156-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD065156-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perinatal Dyadic Psychotherapy', 'description': 'The Perinatal Dyadic Psychotherapy intervention consists of 8 home-based, nurse-delivered mother-infant sessions consisting of (a) a supportive, relationship-based, mother-infant psychotherapeutic component, and (b) a developmentally based infant-oriented component focused on promoting positive mother-infant interactions. The 8 sessions take place over three months with weekly 4 sessions (weeks 1 through 4) followed by 4 every other week sessions (weeks 5 through 8)', 'interventionNames': ['Behavioral: Perinatal Dyadic Psychotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard care plus depression monitoring', 'description': "Standard care plus depression monitoring by phone on a schedule comparable to the intervention groups' home visits. Eight phone calls will take place over three months with weekly 4 calls (weeks 1 through 4) followed by 4 every other week calls (weeks 5 through 8). Phone monitoring will include administration of the Edinburgh Postnatal Depression Scale.", 'interventionNames': ['Behavioral: Placebo Comparator']}], 'interventions': [{'name': 'Perinatal Dyadic Psychotherapy', 'type': 'BEHAVIORAL', 'description': "8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months", 'armGroupLabels': ['Perinatal Dyadic Psychotherapy']}, {'name': 'Placebo Comparator', 'type': 'BEHAVIORAL', 'description': 'Standard care plus depression monitoring by phone', 'armGroupLabels': ['Standard care plus depression monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Insiitute of Health Professions', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Janice H Goodman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH Institute of Health Professions'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Wood Johnson Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Janice H. Goodman', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}