Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-03-15 @ 8:21 PM
Study NCT ID:
NCT02760004
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nancy.Byatt@umassmemorial.org', 'phone': '508.856.5812', 'title': 'Nancy Byatt, Tenured Professor of Psychiatry, ObGyn, and Population & Quantitative Health Sciences', 'organization': 'UMass Chan Medical School / UMass Memorial Health'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '37 months - throughout the enrollment period', 'eventGroups': [{'id': 'EG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • Access to MCPAP for Moms\n\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\nAccess to MCPAP for Moms: • 30-60 minute presentation on perinatal depression\n\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 1, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hospitalization for suicidal risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Edinburgh Postnatal Depression Scale Score (EPDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment'}, {'id': 'OG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\n* 30-60 minute presentation on perinatal depression\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 13 months postpartum', 'description': 'EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the participants enrolled in the study, data was obtained and analyzed for 118 participants in the PRISM Intervention and 117 in the MCPAP for Moms for this outcome measure. These subgroups are based on the number of Participants who had both the baseline EPDS score and a final 11-13 months postpartum EPDS score. Participants can enter at \\[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.'}, {'type': 'SECONDARY', 'title': 'Participants Initiating Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • Access to MCPAP for Moms\n\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment'}, {'id': 'OG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\n* 30-60 minute presentation on perinatal depression\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to up to 13 months postpartum', 'description': 'Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants can enter at \\[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.'}, {'type': 'SECONDARY', 'title': 'Participants Sustaining Mental Health Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • Access to MCPAP for Moms\n\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment'}, {'id': 'OG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\n* 30-60 minute presentation on perinatal depression\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to up to 13 months postpartum', 'description': 'Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants can enter at \\[0 -20 weeks GA, 20-40 weeks GA or 0-12 weeks postpartum\\] and this serves as Baseline. Final measurement occurs at 11 to 13 months postpartum.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • Access to MCPAP for Moms\n\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment'}, {'id': 'FG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\nAccess to MCPAP for Moms: • 30-60 minute presentation on perinatal depression\n\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '150'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '137'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '13'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'typeUnitsAnalyzed': 'OB Practices', 'recruitmentDetails': 'Participants were enrolled from the 10 participating OB/Gyn practices from October 2017 to November 2020. The 10 obstetric practices were randomized to one of the two interventions (5 each) and patient participants from these practices provided data for evaluating the effectiveness of each intervention. Individual patient participant data were analyzed to assess effectiveness.', 'preAssignmentDetails': 'Of the 1265 screened, 312 met the inclusion criteria. The practices were randomized to the 2 intervention arms of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRISM Intervention', 'description': 'PRogram In Support of Moms (PRISM)\n\nPRogram In Support of Moms (PRISM): • Access to MCPAP for Moms\n\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment'}, {'id': 'BG001', 'title': 'MCPAP for Moms', 'description': 'MCPAP for Moms\n\nAccess to MCPAP for Moms: • 30-60 minute presentation on perinatal depression\n\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '6', 'groupId': 'BG000'}, {'value': '33', 'spread': '6', 'groupId': 'BG001'}, {'value': '32', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Grade school/Some high school', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'High school diplomaor GED equivalent', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Some college no degree', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Associate degree', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': "Bachelor's degree", 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': "Master's degree", 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Doctoral degree or equivalent', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Other - Missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary source of payment for prenatal care', 'classes': [{'categories': [{'title': 'Tricare/Self-pay/Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Private or Commercial', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Medicaid/Mass Health/Other public', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-09', 'size': 721778, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-18T14:47', 'hasProtocol': True}, {'date': '2023-05-09', 'size': 184147, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-18T14:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2016-04-27', 'resultsFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-07', 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Edinburgh Postnatal Depression Scale Score (EPDS)', 'timeFrame': 'Baseline up to 13 months postpartum', 'description': 'EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).'}], 'secondaryOutcomes': [{'measure': 'Participants Initiating Treatment', 'timeFrame': 'Baseline to up to 13 months postpartum', 'description': 'Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.'}, {'measure': 'Participants Sustaining Mental Health Treatment', 'timeFrame': 'Baseline to up to 13 months postpartum', 'description': 'Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '11058490', 'type': 'BACKGROUND', 'citation': 'Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.'}, {'pmid': '3651732', 'type': 'BACKGROUND', 'citation': 'Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.'}, {'pmid': '21941662', 'type': 'BACKGROUND', 'citation': "Chen H, Wang J, Ch'ng YC, Mingoo R, Lee T, Ong J. Identifying mothers with postpartum depression early: integrating perinatal mental health care into the obstetric setting. ISRN Obstet Gynecol. 2011;2011:309189. doi: 10.5402/2011/309189. Epub 2011 Sep 15."}, {'pmid': '17199460', 'type': 'BACKGROUND', 'citation': "Flynn HA, O'Mahen HA, Massey L, Marcus S. The impact of a brief obstetrics clinic-based intervention on treatment use for perinatal depression. J Womens Health (Larchmt). 2006 Dec;15(10):1195-204. doi: 10.1089/jwh.2006.15.1195."}, {'pmid': '21261444', 'type': 'BACKGROUND', 'citation': 'Burton A, Patel S, Kaminsky L, Rosario GD, Young R, Fitzsimmons A, Canterino JC. Depression in pregnancy: time of screening and access to psychiatric care. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1321-4. doi: 10.3109/14767058.2010.547234. Epub 2011 Jan 24.'}, {'pmid': '20156110', 'type': 'BACKGROUND', 'citation': 'Goodman JH, Tyer-Viola L. Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Womens Health (Larchmt). 2010 Mar;19(3):477-90. doi: 10.1089/jwh.2008.1352.'}, {'pmid': '20726926', 'type': 'BACKGROUND', 'citation': 'Glavin K, Smith L, Sorum R, Ellefsen B. Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. J Clin Nurs. 2010 Nov;19(21-22):3051-62. doi: 10.1111/j.1365-2702.2010.03332.x. Epub 2010 Aug 19.'}, {'pmid': '19490523', 'type': 'BACKGROUND', 'citation': 'Glavin K, Smith L, Sorum R. Prevalence of postpartum depression in two municipalities in Norway. Scand J Caring Sci. 2009 Dec;23(4):705-10. doi: 10.1111/j.1471-6712.2008.00667.x. Epub 2009 Aug 29.'}, {'pmid': '15816782', 'type': 'BACKGROUND', 'citation': 'Chaudron LH, Kitzman HJ, Peifer KL, Morrow S, Perez LM, Newman MC. Prevalence of maternal depressive symptoms in low-income Hispanic women. J Clin Psychiatry. 2005 Apr;66(4):418-23. doi: 10.4088/jcp.v66n0402.'}, {'pmid': '20717496', 'type': 'BACKGROUND', 'citation': 'Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.'}, {'pmid': '20705376', 'type': 'BACKGROUND', 'citation': 'McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. 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Results of a Statewide Survey of Obstetric Clinician Depression Practices. J Womens Health (Larchmt). 2022 May;31(5):675-681. doi: 10.1089/jwh.2021.0147. Epub 2021 Sep 2.'}, {'pmid': '31710859', 'type': 'DERIVED', 'citation': 'Masters GA, Brenckle L, Sankaran P, Person SD, Allison J, Moore Simas TA, Ko JY, Robbins CL, Marsh W, Byatt N. Positive screening rates for bipolar disorder in pregnant and postpartum women and associated risk factors. Gen Hosp Psychiatry. 2019 Nov-Dec;61:53-59. doi: 10.1016/j.genhosppsych.2019.09.002. Epub 2019 Oct 22.'}, {'pmid': '31331292', 'type': 'DERIVED', 'citation': 'Moore Simas TA, Brenckle L, Sankaran P, Masters GA, Person S, Weinreb L, Ko JY, Robbins CL, Allison J, Byatt N. The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3.'}], 'seeAlsoLinks': [{'url': 'http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1436349', 'label': 'Comparing regression coefficients between models using logit and probit: a new method. Available online at Social Science Research Network, 2010. (Accessed Accessed August, 2011)'}, {'url': 'http://papers.ssrn.com/sol3/papers.cfm?abstractid=1730065', 'label': 'Total, direct, and indirect effects in logit models. 2010. (Accessed Accessed August, 2011'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth.', 'detailedDescription': "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, and children's behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the vast majority of perinatal women are amenable to being screened for depression, screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a comprehensive intervention that is proactive, multifaceted, and practical. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to immediate resource provision/referrals and 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. PRISM builds on a low-cost and widely disseminated population-based model for delivering psychiatric care in primary care settings developed by our team. Because it uses existing infrastructure and resources, PRISM, has the potential to be feasible, sustainable, and transportable to other practice settings. The Investigators will compare PRISM vs. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group)."}, '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 weeks Gestational age (GA) until 4 months postpartum\n5. Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)\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 verbal consent\n\nExclusion Criteria:\n\n1. Lack of verbal and written English fluency\n2. Under age 18 or over age 55\n3. substance use disorder as determined by the questions in 4 Ps questionnaire\n4. Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)\n5. Prisoner\n6. Women participating in 'Moms do care' study"}, 'identificationModule': {'nctId': 'NCT02760004', 'acronym': 'PRISM', 'briefTitle': 'PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics', 'orgStudyIdInfo': {'id': 'H00009163'}, 'secondaryIdInfos': [{'id': '1U01DP006093', 'link': 'https://reporter.nih.gov/quickSearch/1U01DP006093', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prism Intervention', 'description': 'PRogram In Support of Moms (PRISM)', 'interventionNames': ['Behavioral: PRogram In Support of Moms (PRISM)']}, {'type': 'EXPERIMENTAL', 'label': 'MCPAP for Moms Intervention', 'description': 'MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms)', 'interventionNames': ['Behavioral: MCPAP for Moms']}], 'interventions': [{'name': 'PRogram In Support of Moms (PRISM)', 'type': 'BEHAVIORAL', 'otherNames': ['Rapid Access to Perinatal Psychiatric care in Depression'], 'description': '* Access to MCPAP for Moms\n* PRogram In Support of Moms Toolkit with Stepped Care Algorithms\n* Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform\n* Customization of depression screening for each practice\n* Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)\n* Employ psychoeducation and Motivational Interviewing to engage patients with depression\n* medical assistant champion and psychiatrist contact bi-weekly to review cases\n* Stepped care treatment to depression screening/assessment', 'armGroupLabels': ['Prism Intervention']}, {'name': 'MCPAP for Moms', 'type': 'BEHAVIORAL', 'description': '* 30-60 minute presentation on perinatal depression\n* Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns\n* Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation\n* Access to assessment and treatment protocols in Provider Toolkit\n* Resource provision/referrals', 'armGroupLabels': ['MCPAP for Moms Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Medical School/UMass Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Nancy Byatt, DO, MS, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Medical School/UMass Memorial Health Care'}, {'name': 'Tiffany A Moore Simas, MD, MPH, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Medical School/UMass Memorial Health Care'}, {'name': 'Jeroan J Allison, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Massachusetts Medical School/UMass Memorial Health Care'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Starting 6 months after main publication up to a period of 3 years.', 'ipdSharing': 'YES', 'description': 'IPD sharing plan is as applicable with CDC requirements and policy. All IPD that underlie results in a publication will be shared. Analysis of the data by approved researchers will only be conducted as delineated in the approved proposal. Only the minimum amount of data necessary to accomplish the proposed analysis will be released and must be destroyed after the specified analysis has been completed. All analyses will be subjected to independent verification.', 'accessCriteria': 'All researchers who work with the PRISM data will submit a proposal and sign a data-sharing agreement. Researchers will first submit a proposal which will be reviewed by the PRISM Publication Committee. If the proposal is approved, the researcher will sign a data-sharing agreement in which they commit to 1) using the data only for research purposes, 2) keeping the data secure using proper technological precautions, 3) destroying the data after analyses are completed, and 4) only conduct analyses described in the approved proposal.\n\nOur research team will create de-identified analytical datasets and share them with approved researchers as .CSV files that will be transferred by secure encrypted transfer using a secure managed data transfer server.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry and Obstetrics & Gynecology', 'investigatorFullName': 'Nancy Byatt', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}