Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06049433
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2023-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal Mental Health Access - MaMa
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000029', 'term': 'Abortion, Legal'}, {'id': 'C000608097', 'term': 'DMAC2L protein, human'}], 'ancestors': [{'id': 'D000028', 'term': 'Abortion, Induced'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-16', 'size': 321240, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-14T15:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implementation Outcome; Patient engagement', 'timeFrame': '6, 12 & 18 months)', 'description': 'EPDS screening- Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Using score 9-13. Evaluate preference \\& engagement in an 8-week remote-access MBCT or a program;;multimedia on- demand (OD) alone, or OD with a facilitated discussion board (DB) or OD with facilitated, synchronous videoconference sessions (VC).'}, {'measure': 'Exploratory analysis of patient symptom', 'timeFrame': '6, 12 & 18 months)', 'description': 'EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Usinf score 9-20. Conduct an exploratory analysis of PD symptom trajectory for all paired study groups. The Edinburgh Postnatal Depression Scale (EPDS) will be completed at five timepoints (pre- and post- intervention, and 2-, 4-, and 6-months post-intervention) to model change over time.'}], 'primaryOutcomes': [{'measure': 'Implementation outcome; Feasibility and acceptability', 'timeFrame': '(6, 12 & 18 months)', 'description': 'EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Using scores that are between 9-20 Qualitative; semi structured interview Quantitative; patient satisfaction survey, number of referrals for at-risk patients, patients registering on YoMingo. focus groups, individual interviews, questionnaires'}], 'secondaryOutcomes': [{'measure': 'Sociocultural Determinants and Behavior', 'timeFrame': '6, 12 & 18 months)', 'description': 'EPDS Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder.- using EPDS score between 9-20. Life events, cultural/ethnical/racial group membership, history of depression, mental stigma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Depression', 'Perinatal Depression']}, 'descriptionModule': {'briefSummary': 'This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory.\n\nUsing the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio', 'detailedDescription': 'This type1 hybrid effectiveness-implementation project is conducted within healthcare settings and underserved populations (rural, urban, and Latino) and for individuals who are at risk for perinatal depression (PD), which allows the team to refine the approach in preparation for a future effectiveness trial for the prevention of PD in diverse communities using accessible Digital Mental Health Technology (patient education portal, FB discussion boards, synchronous videoconference support sessions). The plan is to adopt a randomized preference trial design to assess the impact of patient preference and sociocultural factors (including race, ethnicity, and geographic residence) on engagement and preliminary results. This information is crucial for a subsequent trial and for ultimately taking the intervention to scale. The study design using the IRLM reflects scientific rigor that can be reproduced by other investigators. The implemented strategies specifically developed to optimize implementation success, and to measure the implementation outcomes of these strategies and include valuable input from key informants, stakeholders, and the Community Advisory Board at regular intervals throughout the project time period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant and or postpartum women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+ years of age, who at the time of screening\n* Have a viable pregnancy or are postpartum (up to 1 year)\n* Identified as at-risk for PD (any one of the following:\n* EPDS score equal to or greater than 9 or less than 21\n* History of depression/anxiety\n* 2 or more significant life events)\n* English- or Spanish-speaking\n* Currently attending a UHealth clinic or rural public health partner clinic.\n\nExclusion Criteria:\n\n* Have a substance use disorder\n* Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \\> 20)\n* Severe anxiety, suicidality, or currently taking any medications for a mental health condition.'}, 'identificationModule': {'nctId': 'NCT06049433', 'acronym': 'MaMa', 'briefTitle': 'Maternal Mental Health Access - MaMa', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Prevention of Perinatal Depression Among At-risk Individuals Through Integration of a Multimedia, Web-based Intervention Within the Healthcare System', 'orgStudyIdInfo': {'id': '00159109'}, 'secondaryIdInfos': [{'id': 'RF1NR020841', 'link': 'https://reporter.nih.gov/quickSearch/RF1NR020841', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Choice 1', 'description': 'Options; On-Demand (OD) alone or On-Demand (OD) with a facilitated discussion board (DB)', 'interventionNames': ['Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention', 'Behavioral: On-Demand + Discussion board (DB)']}, {'type': 'OTHER', 'label': 'Choice 2', 'description': 'Options:\n\nOn-Demand (OD) + Discussion board (DB) or OD + Video Conference (VC)', 'interventionNames': ['Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention', 'Behavioral: Arm 2', 'Behavioral: On Demand (OD) + Video Conference (VC)']}, {'type': 'OTHER', 'label': 'Choice 3', 'description': 'Options; Om-Demand (OD) or On-Demand (OD) + Video Conference (VC)', 'interventionNames': ['Behavioral: Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention', 'Behavioral: Arm 3', 'Behavioral: On Demand (OD) + Video Conference (VC)']}], 'interventions': [{'name': 'Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Arm 1', 'On-Demand (OD)'], 'description': "The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings. MBCT can be delivered individually and in groups and via electronic platforms, in diverse populations. We have adapted UPLIFT for this study, based on input from focus groups and in response to the ongoing pandemic, and under the direction of our team's mental health professionals. Adaptations include access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content),", 'armGroupLabels': ['Choice 1', 'Choice 2', 'Choice 3']}, {'name': 'On-Demand + Discussion board (DB)', 'type': 'BEHAVIORAL', 'description': 'Adaptations include access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC) reduced from 8 weekly one-hour sessions to 4 one-hour sessions every two weeks. a discussion board with the potential to build a sense of community in a similar way that synchronous VC groups provide.', 'armGroupLabels': ['Choice 1']}, {'name': 'Arm 2', 'type': 'BEHAVIORAL', 'otherNames': ['On-Demand (OD) + Discussion Board (DB)'], 'description': 'The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings. MBCT can be delivered individually and in groups and via electronic platforms, in diverse populations. On-demand multi-media MBCT content (digital audio-video files and downloadable content)', 'armGroupLabels': ['Choice 2']}, {'name': 'On Demand (OD) + Video Conference (VC)', 'type': 'BEHAVIORAL', 'description': 'on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC) reduced from 8 weekly one-hour sessions to 4 one-hour sessions every two weeks. A discussion board with the potential to build a sense of community in a similar way that synchronous VC groups provide.', 'armGroupLabels': ['Choice 2']}, {'name': 'Arm 3', 'type': 'BEHAVIORAL', 'otherNames': ['On Demand (OD)'], 'description': 'The intervention uses a standardized, manualized program (UPLIFT - Using Practice and Learning to Increase Favorable Thoughts) based on Mindfulness-Based Cognitive Behavioral Therapy (MBCT) in the prevention of depression in various populations and settings.', 'armGroupLabels': ['Choice 3']}, {'name': 'On Demand (OD) + Video Conference (VC)', 'type': 'BEHAVIORAL', 'description': 'Access to asynchronous, on-demand multi-media MBCT content (digital audio-video files and downloadable content), as well as synchronous Videoconference (VC)', 'armGroupLabels': ['Choice 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gwen Latendresse, PhD CNM', 'role': 'CONTACT', 'email': 'gwen.latendresse@nurs.utah.edu', 'phone': '801-587-9636'}, {'name': 'Julie Neuberger, BS', 'role': 'CONTACT', 'email': 'julie.neuberger@nurs.utah.edu', 'phone': '801-587-3930'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Gwen Latendresse, PhD CNM', 'role': 'CONTACT', 'email': 'gwen.latendresse@nurs.utah.edu', 'phone': '(801) 587-9636'}, {'name': 'Julie Neuberger, BS', 'role': 'CONTACT', 'email': 'julie.neuberger@nurs.utah.edu', 'phone': '801-587-3930'}], 'overallOfficials': [{'name': 'Gwen Latendresse', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gwen Latendresse', 'investigatorAffiliation': 'University of Utah'}}}}