Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04886856
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindful Moms Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064186', 'term': 'Prenatal Education'}], 'ancestors': [{'id': 'D010353', 'term': 'Patient Education as Topic'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive symptom severity', 'timeFrame': 'Baseline to postpartum, about 8 months', 'description': 'Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The EDPS is a widely used and validated measure of depressive symptoms, with 10 questions appropriate for the prenatal and postpartum woman; a score ≥10 (range 0-30) suggests possible depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety', 'timeFrame': 'Baseline to postpartum, about 8 months', 'description': 'Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.'}, {'measure': 'Change in stress', 'timeFrame': 'Baseline to postpartum, about 8 months', 'description': 'Stress will be assessed using the JHP Contextualized Stress Measure. The JHP measures the stressors and coping mechanisms to which women are exposed to, with a range of score from 25-125 (higher score indicates higher stress)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '37500008', 'type': 'DERIVED', 'citation': 'Kinser PA, Bodnar-Deren S, Amstadter AB, Lapato DM, Thacker LR, Johnson JA, Aubry C, Johnson A, Gault C, Hill-Thomas A, Russell S, Lanni S, Freeman A. Study protocol for the Mindful Moms Study: A randomized controlled trial evaluating a mindful movement intervention for marginalized pregnant people experiencing depression. Contemp Clin Trials. 2023 Sep;132:107302. doi: 10.1016/j.cct.2023.107302. Epub 2023 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether a program called "Mindful Moms" can be helpful for specific measures of mood and health in pregnant women with depressive symptoms, compared to group-based education workshops.', 'detailedDescription': 'The Mindful Moms Study is a randomized controlled trial, in which participants will be randomly assigned (like the flip of a coin) to either the "Mindful Moms" group (12 weeks of group-based prenatal yoga) or the "Prenatal Education Circle" group (12 weeks of group-based prenatal education). 200 pregnant women will participate over the course of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant woman at 12-26 weeks gestation at baseline visit;\n2. defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, \\& Children \\[WIC\\] benefits in Virginia and/or educational attainment ≤high school education;\n3. ≥age 18;\n4. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS);\n5. able to read, write, and understand English;\n6. has not been told by a healthcare provider to avoid physical activity;\n7. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy.\n\nExclusion Criteria: Does not meet the inclusion criteria above.'}, 'identificationModule': {'nctId': 'NCT04886856', 'briefTitle': 'Mindful Moms Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Mindful Moms Randomized Control Trial Study', 'orgStudyIdInfo': {'id': 'HM20021720'}, 'secondaryIdInfos': [{'id': '1R01NR020220', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR020220', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Moms', 'description': 'Weekly "Mindful Moms" sessions', 'interventionNames': ['Behavioral: Mindful Moms']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prenatal Education', 'description': 'Weekly prenatal education sessions', 'interventionNames': ['Behavioral: Prenatal Education']}], 'interventions': [{'name': 'Mindful Moms', 'type': 'BEHAVIORAL', 'description': 'Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.', 'armGroupLabels': ['Mindful Moms']}, {'name': 'Prenatal Education', 'type': 'BEHAVIORAL', 'description': 'Twelve 75 minutes weekly group sessions involving prenatal education (for example, what to expect during your pregnancy, during labor and delivery, and after the delivery of your child).', 'armGroupLabels': ['Prenatal Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Patricia Kinser, PhD', 'role': 'CONTACT', 'email': 'kinserpa@vcu.edu', 'phone': '804-828-9140'}, {'name': 'Christine Aubry, RN', 'role': 'CONTACT', 'email': 'aubrych@vcu.edu'}], 'overallOfficials': [{'name': 'Patricia Kinser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}