Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 6:27 PM
Study NCT ID:
NCT05144893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2021-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Virtual Mindfulness-based Group Intervention with Social Support for Perinatal Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - Interest', 'timeFrame': 'at 1 week', 'description': 'the number of individuals interested in participation.'}, {'measure': 'Feasibility - Attendance', 'timeFrame': 'up to 2 months', 'description': 'the number of individuals who attend group and the average number of groups attended.'}, {'measure': 'Acceptability', 'timeFrame': 'up to 2 months', 'description': 'Acceptability will be assessed using the Customer Satisfaction Questionnaires (CSQ-8). Scores range from 8-32 with higher scores indicating higher satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy-specific stress', 'timeFrame': 'up to 2 months', 'description': 'Pregnancy-specific stress will be measured using and the Prenatal Distress Questionnaire (PDQ). Scores range from 0 to 46 with higher scores indicating higher distress.'}, {'measure': 'Psychological Distress', 'timeFrame': 'up to 2 months', 'description': 'Overall psychological distress will be measured using the Center for Epidemiological Studies Depression - Revised (CESD-R). Scores range from 0 to 60 with higher scores indicating more severe depressive symptomatology.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Substance Use', 'Pregnancy Related', 'Mental Health']}, 'descriptionModule': {'briefSummary': 'This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently pregnant\n* Have a single gestation pregnancy\n* Fluently speak English\n* A history of significant substance use or currently in treatment for a substance use disorder.\n\nExclusion Criteria:\n\n* Inability to provide consent'}, 'identificationModule': {'nctId': 'NCT05144893', 'briefTitle': 'Brief Virtual Mindfulness-based Group Intervention with Social Support for Perinatal Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'CPO Pilot: Brief Virtual Mindfulness Based Group Intervention with Social Support', 'orgStudyIdInfo': {'id': 'STUDY00022406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Mindfullness-Based Support Group', 'description': 'The virtual mindfulness-based intervention with social support groups will meet once a week for 4 weeks, each session will be 60 minutes. Each group will have 3-8 participants. The groups will be closed, meaning the same group of participants meet with the same instructor (unless a backup instructor is needed due to unavoidable reasons). Groups will be completed using the video conferencing application.', 'interventionNames': ['Behavioral: Virtual Mindfullness-Based Intervention']}], 'interventions': [{'name': 'Virtual Mindfullness-Based Intervention', 'type': 'BEHAVIORAL', 'description': "Virtual administration of the social support components of an adapted 4-week Mindfulness Based Cognitive Therapy for Postpartum Depression (MBCT-PD) intervention. Each session includes a review of assigned online mindfulness practice and barriers to practice, other homework if also assigned, psychoeducation, and mindfulness practices relevant to the session's theme.", 'armGroupLabels': ['Virtual Mindfullness-Based Support Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Olivia J Doyle, BA', 'role': 'CONTACT', 'email': 'doyleo@ohsu.edu', 'phone': '503-933-0608'}], 'overallOfficials': [{'name': 'Kristen Mackiewicz Seghete, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': '12 months after final data collectins is concluded through 2 years after publications.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results of this study will be shared with proper approval.', 'accessCriteria': 'The Principal Investigator (PI) will review requests for individual participant data (IPD). IPD will be provided with appropriate Institutional Review Board approval or determination. IPD may be provided to investigators associated with a university or reputable research institution with an associated Institutional Review Board (IRB). De-identified IPD will be provided through a secure sharing mechanism.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oregon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kristen Mackiewicz Seghete', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}