Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-07-06 @ 2:10 AM
Study NCT ID:
NCT03623620
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preventing Depressive Relapse in Pregnant Women With Recurrent Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lcohen2@mgh.harvard.edu', 'phone': '617-724-8020', 'title': 'Lee Cohen, MD', 'organization': "Massachusetts General Hospital, Center for Women's Mental Health"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'March 12, 2019 to September 12, 2021 (18 months)', 'description': 'Adverse events were probed for in every phone interview with study participants using standardized health questionnaires for each interview timepoint.', 'eventGroups': [{'id': 'EG000', 'title': 'Digital Delivery of MBCT (Mindful Mood Balance for Moms)', 'description': 'Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.\n\nDigital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 177, 'seriousNumAtRisk': 249, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 209, 'seriousNumAtRisk': 251, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'All events categorized as "unexpected" and "non-Severe"', 'notes': 'Any non-severe, unexpected, and non-study related complications occurring during the perinatal period (ex: placenta problems, gestational diabetes, eclampsia/pre-eclampsia, pre-term labor/delivery, breech/abnormal fetal presentation, etc.)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 177, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 209, 'numAffected': 209}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Relapse of Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Delivery of MBCT (Mindful Mood Balance for Moms)', 'description': 'Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.\n\nDigital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through 6 months postpartum', 'description': 'Depression relapse from randomization through 6 month postpartum', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital Delivery of MBCT (Mindful Mood Balance for Moms)', 'description': 'Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.\n\nDigital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The UPWARD randomized clinical trial was conducted nationally, recruiting euthymic pregnant women with recurrent depression treated with antidepressants. Participant recruitment for UPWARD began March 7, 2019, and concluded July 8, 2020.', 'preAssignmentDetails': '745 individuals were eligible after the initial phone screen, 512 completed the baseline interview and surveys (66 were found ineligible during the baseline interview, 20 did not complete baseline surveys within 1 week, and 147 were non-responsive to follow-up), and 500 were randomized (12 were lost to follow up before randomization).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digital Delivery of MBCT (Mindful Mood Balance for Moms)', 'description': 'Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.\n\nDigital Delivery of Mindfulness-Based Cognitive Therapy: 12-week program that emphasizes mindfulness and cognitive behavioral skills'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '4.65', 'groupId': 'BG000'}, {'value': '32.2', 'spread': '4.43', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '4.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '500', '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': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-17', 'size': 1362031, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-10T12:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2018-08-02', 'resultsFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-10', 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Relapse of Depression', 'timeFrame': 'Randomization through 6 months postpartum', 'description': 'Depression relapse from randomization through 6 month postpartum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Pregnancy', 'Antidepressants', 'Mindfulness', 'Medication use during pregnancy', 'Depression Relapse', 'Suicidal ideation'], 'conditions': ['Depression', 'Pregnancy Related', 'Antenatal Depression']}, 'referencesModule': {'references': [{'pmid': '16449615', 'type': 'BACKGROUND', 'citation': 'Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.'}, {'pmid': '26654212', 'type': 'BACKGROUND', 'citation': 'Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to conduct a pragmatic effectiveness trial comparing digital mindfulness-based cognitive therapy (MBCT) plus usual care to usual care (UC) only among euthymic pregnant women with recurrent depression treated with antidepressants.\n\nIn the supplemental arms we will investigate the prevalence, severity, longitudinal course, correlates, and predictors of suicidal ideation and behavior among women during pregnancy and the postpartum period.', 'detailedDescription': 'This study will address a significant gap in the evidence regarding effective approaches to prevent depressive relapse among women with recurrent depression who maintain euthymia using antidepressants and who wish to conceive or who are pregnant. Relapse rates of depression following antidepressant discontinuation among such women has been established, and the efficacy of MBCT in mitigating relapse risk in pregnant women with recurrent depression compared to UC also has been demonstrated. But the effectiveness of MBCT has not been tested in a definitive trial; the question of whether MBCT can mitigate risk for depressive relapse among pregnant women on antidepressants, including among those who discontinue antidepressants proximate to or during pregnancy, also has not been addressed.\n\nReproductive age women with recurrent depression and their healthcare providers need to know, first, if a scalable digital non-pharmacologic prevention approach is superior to UC in community settings, and second, whether MBCT can attenuate risk for depressive relapse among those who elect to discontinue maintenance antidepressant treatment proximate to or during pregnancy. Lastly, the capacity to identify which women are most likely to benefit from a non-pharmacologic or pharmacologic approach personalizes the risk benefit decision making process for reproductive age women on antidepressants planning to conceive or who are pregnant.\n\nInvestigators will test the relative risk for depressive relapse and reduction of symptom burden between women randomized to digital MBCT or UC, explore the specific benefit of MBCT relative to antidepressant discontinuation, and determine whether a treatment selection algorithm can predict whether MBCT or UC will work best for a specific participant.\n\nThe supplemental arms of this study will further investigate suicidal ideation and behavior in a perinatal population to better understand the prevalence, severity, longitudinal course, correlates and predictors of suicidal ideation and behavior among women during pregnancy and in the postpartum period.\n\nInvestigators will use a mixed methods approach of both cross-sectional and longitudinal study designs to characterize a real-world population of pregnant and postpartum women who have endorsed suicidality. Investigators will also use qualitative interviews, self-report instruments, and medical records to explore the extent to which community healthcare professionals providing care to perinatal women report the knowledge base and requisite skills to address suicidal ideation and behavior in this population.\n\nMMB for Moms delivers digitally both the content and structure of in-person MBCT, and may be a promising intervention for pregnant women with suicidal ideation. Investigators will also explore the safety, feasibility, and acceptability of enrolling pregnant women with any reports of suicidal ideation or behavior in a proof of concept randomized controlled trial comparing MMB for Moms to enhanced usual care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* Ages 18 or older\n* History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated)\n* Euthymic or with residual symptoms (PHQ-9 ≤ 9)\n* No depressive relapse since last menstrual period\n* Currently or recently received antidepressants (within the three months prior to last menstrual period)\n* Presence of ongoing community provider\n\nExclusion Criteria:\n\n* Diagnosis of bipolar or psychotic disorder\n* Active mania, psychosis, or substance abuse (within the last 6 months)\n* Immediate risk of self-harm\n* Non-English speaking\n\nInclusion and exclusion criteria for the participants in the supplemental arms of the study differ from the main study and are as follows:\n\nArm 1 Aim 1a\n\nInclusion Criteria:\n\n* Pregnant women (prior to 16 weeks gestation)\n* Age 18 or older\n* Presence of an ongoing community prescriber / provider\n* Suicidal ideation as noted by item #9 of the PHQ-9\n* History of recurrent depression, dysthymia or subsyndromal depression\n\nExclusion Criteria:\n\n* Diagnosis of bipolar or psychotic disorder\n* Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)\n* Non-English speaking\n\nArm 1 Aim 1b\n\nInclusion Criteria:\n\n* Age 18 or older\n* Current prenatal healthcare provider of a participant enrolled in Arm 1 Aim 1a\n\nExclusion Criteria:\n\n* Non-English speaking\n\nArm 1 Aim 1c\n\nInclusion Criteria:\n\n* Pregnant women\n* Age 18 or older\n* Self-reported history of major depressive disorder\n* Suicidal ideation as noted by item #9 of the PHQ-9\n\nExclusion Criteria:\n\n* Non-English speaking\n\nArm 2\n\nInclusion Criteria:\n\n* Pregnant women (prior to 16 weeks gestation)\n* Age 18 or older\n* History of recurrent major depression prior to pregnancy (at least two prior episodes, one of which may be currently treated)\n* Euthymic or with residual symptoms (PHQ-9 \\</=9)\n* Presence of an ongoing community prescriber / provider\n* Current suicidal ideation as noted by item #9 of the PHQ-9 or past suicidal ideation as noted by item A3g on the MINI mood module\n\nExclusion Criteria:\n\n* Diagnosis of bipolar or psychotic disorder\n* Mania, psychosis, or active substance abuse (within the last 6 months for substance abuse)\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT03623620', 'briefTitle': 'Preventing Depressive Relapse in Pregnant Women With Recurrent Depression', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Preventing Depressive Relapse in Pregnant Women With Recurrent Depression', 'orgStudyIdInfo': {'id': '2018P001472'}, 'secondaryIdInfos': [{'id': 'R01MH117253', 'link': 'https://reporter.nih.gov/quickSearch/R01MH117253', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital delivery of MBCT (Mindful Mood Balance for Moms)', 'description': 'Subjects will receive digital delivery of mindfulness-based cognitive therapy (Mindful Mood Balance for Moms) for 12 weeks, along with the usual care they would receive from their provider.', 'interventionNames': ['Behavioral: Digital Delivery of Mindfulness-Based Cognitive Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Subjects will receive only usual care, the care they would normally receive from their community provider, for 12 weeks.'}], 'interventions': [{'name': 'Digital Delivery of Mindfulness-Based Cognitive Therapy', 'type': 'BEHAVIORAL', 'description': '12-week program that emphasizes mindfulness and cognitive behavioral skills', 'armGroupLabels': ['Digital delivery of MBCT (Mindful Mood Balance for Moms)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lee S Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Sona Dimidjian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Boulder'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Data will become available 6 months after study start-up and will continue to be available throughout the study.', 'ipdSharing': 'YES', 'description': 'Data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) every 6 months after enrollment begins, and before publication. In addition, de-identified data and accompanying documentation describing and referencing all variables will be available for use by other investigators upon request.', 'accessCriteria': 'Interested investigators will be asked to submit a proposal form, which will be reviewed by the principal investigator for scientific integrity and adherence to ethical guidelines.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Center for Women's Mental Health", 'investigatorFullName': 'Lee S. Cohen, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}