Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-03 @ 5:29 AM
Study NCT ID:
NCT02371356
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2015-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'De-Kun.Li@kp.org', 'phone': '510.891.3749', 'title': 'De-Kun Li, MD, PhD', 'organization': 'Kaiser Permanente Division of Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Overall Study: Through the end of pregnancy, an average of 40 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Depressed, Medication Only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy', 'otherNumAtRisk': 1320, 'deathsNumAtRisk': 1320, 'otherNumAffected': 0, 'seriousNumAtRisk': 1320, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Depressed, Psychotherapy Only', 'description': 'Screen positive for depression and receive psychotherapy only', 'otherNumAtRisk': 7354, 'deathsNumAtRisk': 7354, 'otherNumAffected': 0, 'seriousNumAtRisk': 7354, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy', 'otherNumAtRisk': 2804, 'deathsNumAtRisk': 2804, 'otherNumAffected': 0, 'seriousNumAtRisk': 2804, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Depressed, Untreated', 'description': 'Screen positive for depression and receive no treatment', 'otherNumAtRisk': 7423, 'deathsNumAtRisk': 7423, 'otherNumAffected': 0, 'seriousNumAtRisk': 7423, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Not Depressed', 'description': 'Screen negative for depression and received no treatment', 'otherNumAtRisk': 72183, 'deathsNumAtRisk': 72183, 'otherNumAffected': 0, 'seriousNumAtRisk': 72183, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Preterm Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1320', 'groupId': 'OG000'}, {'value': '7354', 'groupId': 'OG001'}, {'value': '2804', 'groupId': 'OG002'}, {'value': '7423', 'groupId': 'OG003'}, {'value': '72183', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Depressed, Medication Only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy'}, {'id': 'OG001', 'title': 'Depressed, Psychotherapy Only', 'description': 'Screen positive for depression and receive psychotherapy only'}, {'id': 'OG002', 'title': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy'}, {'id': 'OG003', 'title': 'Depressed, Untreated', 'description': 'Screen positive for depression and receive no treatment'}, {'id': 'OG004', 'title': 'Not Depressed', 'description': 'Screen negative for depression and received no treatment'}], 'classes': [{'categories': [{'title': 'Preterm', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}, {'value': '569', 'groupId': 'OG003'}, {'value': '4164', 'groupId': 'OG004'}]}, {'title': 'Not preterm', 'measurements': [{'value': '1181', 'groupId': 'OG000'}, {'value': '6798', 'groupId': 'OG001'}, {'value': '2532', 'groupId': 'OG002'}, {'value': '6854', 'groupId': 'OG003'}, {'value': '68019', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through the end of pregnancy, an average of 40 weeks', 'description': 'Delivery prior to 37 completed weeks of gestational age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Low Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1308', 'groupId': 'OG000'}, {'value': '7251', 'groupId': 'OG001'}, {'value': '2778', 'groupId': 'OG002'}, {'value': '7310', 'groupId': 'OG003'}, {'value': '72073', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Depressed, Medication Only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy'}, {'id': 'OG001', 'title': 'Depressed, Psychotherapy Only', 'description': 'Screen positive for depression and receive psychotherapy only'}, {'id': 'OG002', 'title': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy'}, {'id': 'OG003', 'title': 'Depressed, Untreated', 'description': 'Screen positive for depression and receive no treatment'}, {'id': 'OG004', 'title': 'Not Depressed', 'description': 'Screen negative for depression and received no treatment'}], 'classes': [{'categories': [{'title': 'Low birth weight', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}, {'value': '3154', 'groupId': 'OG004'}]}, {'title': 'Not low birth weight', 'measurements': [{'value': '1226', 'groupId': 'OG000'}, {'value': '6843', 'groupId': 'OG001'}, {'value': '2620', 'groupId': 'OG002'}, {'value': '6925', 'groupId': 'OG003'}, {'value': '68919', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through the end of pregnancy, an average of 40 weeks', 'description': 'Birth weight \\<2500 grams', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Those with missing birth weight information were excluded from the analysis of low birth weight'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Depressed, Medication Only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy'}, {'id': 'FG001', 'title': 'Depressed, Psychotherapy Only', 'description': 'Screen positive for depression and receive psychotherapy only'}, {'id': 'FG002', 'title': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy'}, {'id': 'FG003', 'title': 'Depressed, Untreated', 'description': 'Screen positive for depression and receive no treatment'}, {'id': 'FG004', 'title': 'Not Depressed', 'description': 'Screen negative for depression and received no treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1320'}, {'groupId': 'FG001', 'numSubjects': '7354'}, {'groupId': 'FG002', 'numSubjects': '2804'}, {'groupId': 'FG003', 'numSubjects': '7423'}, {'groupId': 'FG004', 'numSubjects': '72183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1320'}, {'groupId': 'FG001', 'numSubjects': '7354'}, {'groupId': 'FG002', 'numSubjects': '2804'}, {'groupId': 'FG003', 'numSubjects': '7423'}, {'groupId': 'FG004', 'numSubjects': '72183'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1320', 'groupId': 'BG000'}, {'value': '7354', 'groupId': 'BG001'}, {'value': '2804', 'groupId': 'BG002'}, {'value': '7423', 'groupId': 'BG003'}, {'value': '72183', 'groupId': 'BG004'}, {'value': '91084', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Depressed, Medication Only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy'}, {'id': 'BG001', 'title': 'Depressed, Psychotherapy Only', 'description': 'Screen positive for depression and receive psychotherapy only'}, {'id': 'BG002', 'title': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy'}, {'id': 'BG003', 'title': 'Depressed, Untreated', 'description': 'Screen positive for depression and receive no treatment'}, {'id': 'BG004', 'title': 'Not Depressed', 'description': 'Screen negative for depression and received no treatment'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Maternal Age', 'categories': [{'title': '18-24 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '1792', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}, {'value': '1123', 'groupId': 'BG003'}, {'value': '8987', 'groupId': 'BG004'}, {'value': '12458', 'groupId': 'BG005'}]}, {'title': '25-34 years', 'measurements': [{'value': '721', 'groupId': 'BG000'}, {'value': '4117', 'groupId': 'BG001'}, {'value': '1654', 'groupId': 'BG002'}, {'value': '4440', 'groupId': 'BG003'}, {'value': '46148', 'groupId': 'BG004'}, {'value': '57080', 'groupId': 'BG005'}]}, {'title': '35+ years', 'measurements': [{'value': '443', 'groupId': 'BG000'}, {'value': '1445', 'groupId': 'BG001'}, {'value': '750', 'groupId': 'BG002'}, {'value': '1860', 'groupId': 'BG003'}, {'value': '17048', 'groupId': 'BG004'}, {'value': '21546', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1320', 'groupId': 'BG000'}, {'value': '7354', 'groupId': 'BG001'}, {'value': '2804', 'groupId': 'BG002'}, {'value': '7423', 'groupId': 'BG003'}, {'value': '72183', 'groupId': 'BG004'}, {'value': '91084', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Maternal Race/ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '813', 'groupId': 'BG000'}, {'value': '2638', 'groupId': 'BG001'}, {'value': '1610', 'groupId': 'BG002'}, {'value': '2257', 'groupId': 'BG003'}, {'value': '26385', 'groupId': 'BG004'}, {'value': '33703', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '1147', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '1957', 'groupId': 'BG003'}, {'value': '19697', 'groupId': 'BG004'}, {'value': '23069', 'groupId': 'BG005'}]}, {'title': 'African-American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '945', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}, {'value': '577', 'groupId': 'BG003'}, {'value': '3773', 'groupId': 'BG004'}, {'value': '5598', 'groupId': 'BG005'}]}, {'title': 'Hispanic', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '2200', 'groupId': 'BG001'}, {'value': '621', 'groupId': 'BG002'}, {'value': '2208', 'groupId': 'BG003'}, {'value': '18545', 'groupId': 'BG004'}, {'value': '23857', 'groupId': 'BG005'}]}, {'title': 'Other/multiple/unknown', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}, {'value': '3783', 'groupId': 'BG004'}, {'value': '4857', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1320', 'groupId': 'BG000'}, {'value': '7354', 'groupId': 'BG001'}, {'value': '2804', 'groupId': 'BG002'}, {'value': '7423', 'groupId': 'BG003'}, {'value': '72183', 'groupId': 'BG004'}, {'value': '91084', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-12-01', 'size': 496634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-19T17:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91084}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2015-01-28', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-12', 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm Delivery', 'timeFrame': 'Through the end of pregnancy, an average of 40 weeks', 'description': 'Delivery prior to 37 completed weeks of gestational age'}, {'measure': 'Low Birth Weight', 'timeFrame': 'Through the end of pregnancy, an average of 40 weeks', 'description': 'Birth weight \\<2500 grams'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Preterm Delivery']}, 'descriptionModule': {'briefSummary': 'Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.', 'detailedDescription': 'Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. Kaiser Permanente Northern California has implemented a large scale universal peripartum depression screening program, annually screening more than 35,000 pregnant women. Taking advantage of this unique infrastructure, we propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Stakeholders (patients, advocacy groups, and providers) are an integral part of the research team. Four cohorts with different treatment options including untreated will be formed within each depression type (with or without comorbidity): (A) "Antidepressant only": screen positive for depression and use only antidepressants during pregnancy; (B) "Psychotherapy only": screen positive and receive psychotherapy only; (C) "Combination therapy": screen positive and receive both antidepressants and psychotherapy; (D)"Untreated depression": screen positive and receive no treatment. A total of eight cohorts will be formed. A final cohort (E) "No depression": screen negative and receive no treatment, will be examined for baseline comparison. Information on depression treatment and PTD and LBW will be available for all participating women who will be followed until the end of pregnancy. Within each depression category, comparison of Cohort A, B \\& C to D, respectively, will determine if treating depression is effective. Pair-wise comparisons among Cohorts A, B \\& C will determine the comparative effectiveness of treatment regimens. Comparison of Cohort D to E provides baseline fetal risks of untreated depression. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant KPNC members who have been screened as part of KPNC's peripartum depression screening program, assigned to cohorts according to depression and treatment status.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kaiser member\n* Pregnant\n\nExclusion Criteria:\n\n* Not a member of Kaiser Permanente\n* Not pregnant'}, 'identificationModule': {'nctId': 'NCT02371356', 'acronym': 'PCORIPTD', 'briefTitle': 'Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health', 'orgStudyIdInfo': {'id': 'CN-13-1650-H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Depressed, Medication only', 'description': 'Screen positive for depression and use only antidepressants during pregnancy'}, {'label': 'Depressed, Psychotherapy only', 'description': 'Screen positive for depression and receive psychotherapy only.'}, {'label': 'Depressed, Medication & Psychotherapy', 'description': 'Screen positive for depression and receive both antidepressants and psychotherapy.'}, {'label': 'Depressed, untreated', 'description': 'Screen positive for depression and receive no treatment.'}, {'label': 'Not depressed', 'description': 'Screen negative for depression and receive no treatment.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}