Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-26 @ 11:53 AM
Study NCT ID:
NCT02935504
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2016-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRogram In Support of Moms (PRISM): A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Severity', 'timeFrame': 'Baseline to 10-35 weeks follow-up', 'description': 'To compare changes in depression severity as measured by Edinburgh Postnatal Depression Scale (EPDS) from baseline to follow-up (10-35 weeks) among pregnant and postpartum women in PRISM versus MCPAP for Moms.'}], 'secondaryOutcomes': [{'measure': 'Provider Fidelity', 'timeFrame': 'Baseline to 1 year follow-up (post intervention)', 'description': 'To determine change in knowledge, attitudes, and practices as measured by S-KAP toward depression screening and treatment from baseline (pre implementation) to 1 year follow-up (post implementation) among providers in PRISM versus MCPAP for Moms practices.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Pregnancy', 'Postpartum'], 'conditions': ['Perinatal Depression']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Switzerland: Department of Health Statistics and Informatics; Information EaRCotWHO. The Global Burden of Disease: 2004 update; 2008.'}, {'pmid': '20921117', 'type': 'BACKGROUND', 'citation': 'Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010 Oct;67(10):1012-24. doi: 10.1001/archgenpsychiatry.2010.111.'}, {'pmid': '19175819', 'type': 'BACKGROUND', 'citation': 'Paulson JF, Keefe HA, Leiferman JA. Early parental depression and child language development. J Child Psychol Psychiatry. 2009 Mar;50(3):254-62. doi: 10.1111/j.1469-7610.2008.01973.x. Epub 2008 Oct 23.'}, {'pmid': '18651886', 'type': 'BACKGROUND', 'citation': 'Deave T, Heron J, Evans J, Emond A. The impact of maternal depression in pregnancy on early child development. BJOG. 2008 Jul;115(8):1043-51. doi: 10.1111/j.1471-0528.2008.01752.x.'}, {'pmid': '15883651', 'type': 'BACKGROUND', 'citation': 'Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.'}, {'pmid': '15777362', 'type': 'BACKGROUND', 'citation': 'Carter FA, Carter JD, Luty SE, Wilson DA, Frampton CM, Joyce PR. Screening and treatment for depression during pregnancy: a cautionary note. Aust N Z J Psychiatry. 2005 Apr;39(4):255-61. doi: 10.1080/j.1440-1614.2005.01562.x.'}, {'pmid': '21289351', 'type': 'BACKGROUND', 'citation': "Kozhimannil KB, Adams AS, Soumerai SB, Busch AB, Huskamp HA. New Jersey's efforts to improve postpartum depression care did not change treatment patterns for women on medicaid. Health Aff (Millwood). 2011 Feb;30(2):293-301. doi: 10.1377/hlthaff.2009.1075."}, {'pmid': '18390942', 'type': 'BACKGROUND', 'citation': 'Gilbody S, Sheldon T, House A. Screening and case-finding instruments for depression: a meta-analysis. CMAJ. 2008 Apr 8;178(8):997-1003. doi: 10.1503/cmaj.070281.'}, {'pmid': '19252044', 'type': 'BACKGROUND', 'citation': 'Yonkers KA, Smith MV, Lin H, Howell HB, Shao L, Rosenheck RA. Depression screening of perinatal women: an evaluation of the healthy start depression initiative. Psychiatr Serv. 2009 Mar;60(3):322-8. doi: 10.1176/appi.ps.60.3.322.'}, {'pmid': '16551710', 'type': 'BACKGROUND', 'citation': 'Weissman MM, Pilowsky DJ, Wickramaratne PJ, Talati A, Wisniewski SR, Fava M, Hughes CW, Garber J, Malloy E, King CA, Cerda G, Sood AB, Alpert JE, Trivedi MH, Rush AJ; STAR*D-Child Team. Remissions in maternal depression and child psychopathology: a STAR*D-child report. JAMA. 2006 Mar 22;295(12):1389-98. doi: 10.1001/jama.295.12.1389.'}, {'pmid': '19269536', 'type': 'BACKGROUND', 'citation': 'Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.'}, {'pmid': '12804344', 'type': 'BACKGROUND', 'citation': 'Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Womens Health (Larchmt). 2003 May;12(4):373-80. doi: 10.1089/154099903765448880.'}, {'pmid': '22382279', 'type': 'BACKGROUND', 'citation': 'Rowan P, Greisinger A, Brehm B, Smith F, McReynolds E. Outcomes from implementing systematic antepartum depression screening in obstetrics. Arch Womens Ment Health. 2012 Apr;15(2):115-20. doi: 10.1007/s00737-012-0262-6. Epub 2012 Mar 1.'}, {'pmid': '26444130', 'type': 'BACKGROUND', 'citation': 'Byatt N, Levin LL, Ziedonis D, Moore Simas TA, Allison J. Enhancing Participation in Depression Care in Outpatient Perinatal Care Settings: A Systematic Review. Obstet Gynecol. 2015 Nov;126(5):1048-1058. doi: 10.1097/AOG.0000000000001067.'}, {'pmid': '37582274', 'type': 'DERIVED', 'citation': 'McNicholas E, Boama-Nyarko E, Julce C, Nunes AP, Flahive J, Byatt N, Moore Simas TA. Understanding Perinatal Depression Care Gaps by Examining Care Access and Barriers in Perinatal Individuals With and Without Psychiatric History. J Womens Health (Larchmt). 2023 Oct;32(10):1111-1119. doi: 10.1089/jwh.2022.0306. Epub 2023 Aug 16.'}]}, 'descriptionModule': {'briefSummary': "The primary goal of this study is to evaluate the PRogram In Support of Moms (PRISM) that aims to improve women's access to and participation in perinatal depression treatment and thereby improve depression outcomes", 'detailedDescription': 'Major depressive disorder continues to be the leading cause of disability among women of reproductive age and major public health concern. Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, behavior and development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the majority of women are amenable to depression screening, screening alone does not improve treatment entry or outcome. Despite the availability of effective evidence-based treatments and frequent contact with obstetric providers, less than one-third of women who screen positive for depression receive treatment. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed a program called "PRogram In Support of Moms" (PRISM) that aims to leverage existing roles and resources to target patient, provider, and system level barriers to perinatal depression treatment. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. Four practices were randomly assigned to PRISM versus an active comparison group called MCPAP for Moms which is a state-wide telephonic perinatal psychiatry program. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 3 months postpartum among patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female\n2. Age 18-55 years\n3. English speaking\n4. 4-36 weeks gestational age (GA) or 2-12 weeks postpartum\n5. Receiving care from one of the 4 participating clinics (2 clinics which will participate in PRISM and 2 with access to MCPAP for Moms)\n6. Edinburgh Postnatal Depression Scale score (EPDS) ≥10\n7. Able to communicate in written and spoken English; and\n8. Cognitively able to participate in informed consent\n\nExclusion Criteria:\n\n1. Lack of verbal and written English fluency\n2. Under age 18 or over age 55\n3. Current active substance use disorder\n4. Bipolar disorder diagnosis as determined by the Mini-international Neuropsychiatric Interview (M.I.N.I.)\n5. Psychotic component to illness as determined by the M.I.N.I.'}, 'identificationModule': {'nctId': 'NCT02935504', 'acronym': 'PRISM-Pilot', 'briefTitle': 'PRogram In Support of Moms (PRISM): A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'PRogram In Support of Moms (PRISM): A Pilot Group Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H00004195'}, 'secondaryIdInfos': [{'id': 'UL1TR000161', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000161', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Program In Support of Moms PRISM', 'description': 'PRISM includes MCPAP for Moms and training, implementation support, and toolkits for Ob/Gyn practices on depression screening, assessment and treatment.', 'interventionNames': ['Behavioral: PRogram In Support of Moms (PRISM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MCPAP for Moms', 'description': 'Consists of access to psychiatric consultation and resources and referrals through MCPAP for Moms - MCPAP for Moms is available free of charge to all Ob/Gyn practices in Massachusetts.', 'interventionNames': ['Behavioral: MCPAP for Moms']}], 'interventions': [{'name': 'PRogram In Support of Moms (PRISM)', 'type': 'BEHAVIORAL', 'otherNames': ['Rapid Access to Perinatal Psychiatric care in Depression', 'RAPPID'], 'description': 'PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend:\n\nToolkit Care coordination Psychiatric consultation Implementation support\n\n1. Engage clinic leaders and staff\n2. Identify leadership group and prepare for change\n3. Assess readiness to implement PRISM\n4. Identify steps to achieve goals\n5. Implement PRISM components into the clinic\n6. Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention', 'armGroupLabels': ['Program In Support of Moms PRISM']}, {'name': 'MCPAP for Moms', 'type': 'BEHAVIORAL', 'description': 'MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals', 'armGroupLabels': ['MCPAP for Moms']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nancy Byatt, DO, MS, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '• UMass Memorial Medical Center/UMass Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry and Obstetrics & Gynecology', 'investigatorFullName': 'Nancy Byatt', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}