[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04886856":3,"trial-entities:NCT04886856":78,"trial-summary:NCT04886856":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":15,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":67,"overall_officials":68,"references":72,"see_also_links":77},"NCT04886856","HM20021720","Mindful Moms Randomized Control Trial","Mindful Moms Randomized Control Trial Study","COMPLETED","2026-06-30","2026-08","2026-08-20","2021-10-15","Virginia Commonwealth University","OTHER",null,"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.","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.",[19],"Depression",[21],"pregnancy","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},200,"ACTUAL",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Mindful Moms","Twelve 75 minutes weekly group sessions involving gentle yoga practices designed for pregnant women, led by experienced yoga teachers.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Prenatal Education","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).",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Change in Depressive symptom severity","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.","Baseline to postpartum, about 8 months",[45],{"measure":46,"description":47,"timeFrame":43},"Change in anxiety","Anxiety will be assessed using the Perinatal Anxiety Screening Scale (PASS); scores range from 0-93, high scores indicate higher levels of anxiety.","FEMALE","18 Years",false,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. pregnant woman at 12-26 weeks gestation at baseline visit;\n2. ≥age 18;\n3. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS) or a score ≥2 on the PHQ-2;\n4. able to read, write, and understand English or Spanish;\n5. has not been told by a healthcare provider to avoid physical activity;\n6. has not engaged in a consistent (once\u002Fweek or more) yoga-based practice during the current pregnancy.\n\nExclusion Criteria: Does not meet the inclusion criteria above.",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":13,"city":60,"state":61,"zip":62,"country":63,"geoPoint":64},"Richmond","Virginia","23298","United States",{"lat":65,"lon":66},37.55376,-77.46026,[],[69],{"name":70,"affiliation":13,"role":71},"Patricia Kinser, PhD","PRINCIPAL_INVESTIGATOR",[73],{"pmid":74,"type":75,"citation":76},"37500008","DERIVED","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\u002Fj.cct.2023.107302. Epub 2023 Jul 25.",[],{"nct_id":4,"conditions":79,"biomarkers":81},[19,80],"Pregnancy",[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is a randomized controlled trial, meaning participants are randomly assigned to either the \"Mindful Moms\" group or the \"Prenatal Education Circle\" group. About 200 pregnant women will participate.","completed","Mindful Moms Study for Depression in Pregnant Women","This study, called \"Mindful Moms,\" is looking at whether a program of gentle yoga practices can help pregnant women with symptoms of depression. It compares the \"Mindful Moms\" program to a group that receives prenatal education workshops. The study aims to see if the Mindful Moms program can improve mood and health measures. You might be able to join if you are a pregnant woman between 12 and 26 weeks of pregnancy, are at least 18 years old, and identify as a minority or meet certain income or education levels. The study will measure changes in depressive symptoms over about 8 months, from the start of the study until after you've given birth. The current recruitment status is unclear.","Participants will be followed from the start of the study until about 8 months postpartum to measure changes in depressive symptoms.",119,"You would attend twelve 75-minute weekly group sessions, either for gentle yoga or prenatal education. The study measures depressive symptoms from the start of the study until about 8 months later.","Not stated in the trial record.",[32,36],"v2"]