Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 8:07 AM
Study NCT ID:
NCT01482832
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2011-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2011-11-25', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of depression', 'timeFrame': 'within 6 months postpartum', 'description': 'Outcome assessment using KID-SCID'}], 'secondaryOutcomes': [{'measure': 'Degree of depressive symptoms', 'timeFrame': 'pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52', 'description': 'Outcomes assessment using CDRS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized trial', 'Postpartum depression', 'Adolescent pregnancy', 'Interpersonal psychotherapy'], 'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '32769639', 'type': 'DERIVED', 'citation': 'Phipps MG, Ware CF, Stout RL, Raker CA, Zlotnick C. Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):613-621. doi: 10.1097/AOG.0000000000004003.'}]}, 'descriptionModule': {'briefSummary': 'The Specific Aim of this study is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.\n\nPrimary Hypothesis:\n\n1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.\n\n Secondary Hypotheses:\n2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.\n3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.', 'detailedDescription': 'Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health.\n\nProject REACH is a randomized controlled trial, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions.\n\nProject REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Less than 24 weeks pregnant\n* Not currently being treated for depression\n* Speaks and reads English fluently\n\nExclusion Criteria:\n\n* Currently receiving mental health services from a health care provider\n* Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis'}, 'identificationModule': {'nctId': 'NCT01482832', 'acronym': 'REACH 2', 'briefTitle': 'Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Preventing Postpartum Depression in Adolescent Mothers', 'orgStudyIdInfo': {'id': 'R01MH093342', 'link': 'https://reporter.nih.gov/quickSearch/R01MH093342', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH093342', 'link': 'https://reporter.nih.gov/quickSearch/R01MH093342', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Behavioral: Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.', 'interventionNames': ['Behavioral: Interpersonal therapy-based treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Behavioral: Standard care Participants assigned to receive standard care will focus on prenatal education including issues associated with pregnancy and postpartum. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.', 'interventionNames': ['Behavioral: Interpersonal therapy-based treatment']}], 'interventions': [{'name': 'Interpersonal therapy-based treatment', 'type': 'BEHAVIORAL', 'otherNames': ['REACH 2'], 'description': 'Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. (5 weekly sessions with a booster session postpartum)', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women & Infants Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Maureen G Phipps, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women & Infants Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not at this point.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Pacific Institute for Research and Evaluation', 'class': 'OTHER'}, {'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'maureen phipps', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}