[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590160":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":70,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Moms2B","ACTIVE_COMPARATOR","Moms2B is an established group-based intervention for pregnant women focused on enhancing social support and improving nutrition. Participants will receive 3 sessions using this established assessment only treatment plan as well as complete surveys and clinical interviews assessing stress, coping strategies and emotions. Resting heart rate data as well as heart rate data post stimulus to be assessed.",[13],"Behavioral: Moms2B",{"label":15,"type":16,"description":17,"interventionNames":18},"DBT-P","EXPERIMENTAL","DBT-P is a Dialectical Behavior Therapy skills group adapted for pregnant people. Participants will receive weekly DBT-P group sessions for 10 weeks where they learn skills to: (1) enhance self-awareness; (2) improve ability to manage crises; (3) decrease negative emotions and increase positive emotions; (4) improve your relationships and self-respect; they will also complete homework as part of the group participation as well as complete daily diary cards that will ask about their mood and any thoughts of self-harm .\n\nCompletion of surveys and clinical interviews assessing stress, coping strategies and emotions are included; resting heart rate data as well as heart rate data post stimulus to be assessed.",[13,19],"Behavioral: DBT-P",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","An established group-based pregnancy program focusing on improving nutrition, social, and medical support.",[15,9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.",[15],[30,33,35],{"name":31,"affiliation":5,"role":32},"Elisabeth Conradt, PhD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Andrada Neacsiu, PhD",{"name":36,"affiliation":37,"role":32},"Sheila Crowell, PhD","University of Oregon",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Janea Cato","CONTACT","(919) 684-3251","janea.cato@duke.edu",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Alicia Holloway","(919) 684-1333","adh60@duke.edu",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Durham","North Carolina","27705","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-78.89862,35.99403,{"lat":60,"lon":59},[63,65,66,67],{"name":45,"role":41,"phone":64,"phoneExt":25,"email":47},"919-684-1333",{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"name":34,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":69,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[71,74,75],{"name":72,"class":73},"National Institute of Mental Health (NIMH)","NIH",{"name":37,"class":6},{"name":76,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","100590160","dbt-p-treatment-study-100590160",false,"NCT06963801","DBT-P Treatment Study","Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health","REACH","Inclusion Criteria:\n\n* Emotion dysregulation score of 88 or above\n* At least 12 weeks pregnant\n* Singleton Pregnancy\n* Fluent in English\n\nExclusion Criteria:\n\n* Active psychosis\n* Drug or alcohol use disorder during pregnancy\n* High risk of an imminent suicide attempt\n* Significant health complications (e.g., cancer)\n* Illiterate and\u002For unable to independently complete and comprehend written measures","FEMALE","18 Years","45 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate.\n\nThe main questions it aims to answer are:\n\n* Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope?\n* How is a participant's heart rate affected by their ability to control their emotions during pregnancy?\n\nResearchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate.\n\nParticipants will:\n\n* Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy.\n* Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions.\n* Have their heart rate taken.\n* If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm.\n* Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.",[96],"Emotion Dysregulation",[98,99,100,101,102,103,15,9],"Emotion dysregulation","Pregnancy","Maternal health","RSA","Coping","Stress","2026-04-06",{"date":106,"type":107},"2026-04-08","ACTUAL",{"date":109,"type":107},"2025-06-06",{"date":111,"type":90},"2026-10-19",{"name":5,"class":6},1]