[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06963801":3,"trial-entities:NCT06963801":139,"trial-summary:NCT06963801":143},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":44,"secondary_outcomes":52,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":101,"locations":103,"central_contacts":127,"overall_officials":131,"references":137,"see_also_links":138},"NCT06963801","Pro00116252","DBT-P Treatment Study","Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health","RECRUITING","2026-10-19","2026-04","2026-04-08","2025-06-06","Duke University","OTHER",true,"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.","The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories.\n\nThe premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth.\n\nThe primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.",[19],"Emotion Dysregulation",[21,22,23,24,25,26,27,28],"Emotion dysregulation","Pregnancy","Maternal health","RSA","Coping","Stress","DBT-P","Moms2B","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},100,"ESTIMATED",[37,41],{"type":38,"name":28,"description":39,"armGroupLabels":40},"BEHAVIORAL","An established group-based pregnancy program focusing on improving nutrition, social, and medical support.",[27,28],{"type":38,"name":27,"description":42,"armGroupLabels":43},"An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.",[27],[45,49],{"measure":46,"description":47,"timeFrame":48},"Difficulties in Emotion Regulation Scale (DERS)","The DERS is a 36-item measure scored on a 5-point Likert Scale. DERS scores range from 36-180 and enrollment in this study requires a baseline total DERS score of ≥88 which indicate greater difficulties in emotion regulation.","Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)",{"measure":50,"description":51,"timeFrame":48},"Respiratory Sinus Arrhythmia (RSA)","RSA is a peripheral index of parasympathetic nervous system influences on cardiac activity and is measured as the variability in heart rate that coincides with respiration.",[53,56,59,62,65,68,71,74,78,81],{"measure":54,"description":55,"timeFrame":48},"Percent of participation","Feasibility of the assessment schedule will include the percent of participation at all timepoints.",{"measure":57,"description":58,"timeFrame":48},"Percent of missing data","Feasibility of the assessment schedule will include the percent of missing data at all time points.",{"measure":60,"description":61,"timeFrame":48},"Recruitment rates","Feasibility of the intervention will be assessed by evaluating recruitment rates.",{"measure":63,"description":64,"timeFrame":48},"Reasons for refusal","Feasibility of the intervention will be assessed by evaluating reasons for refusal. Collection of reasons for refusal to be obtained via subject self-report at each individual timepoint; expected attendance for 85% of sessions.",{"measure":66,"description":67,"timeFrame":48},"Intervention adherence","Feasibility of the intervention will be assessed by evaluating intervention adherence. Weekly assessment of intervention adherence conducted by clinicians based on subject completion of required homework assignments, daily diary entries and group session attendance.",{"measure":69,"description":70,"timeFrame":48},"Number of women who complete all sessions","Feasibility will be assessed by how many women completed all sessions.",{"measure":72,"description":73,"timeFrame":48},"Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions","Feasibility will be assessed by whether the interventionist can self-monitor for fidelity.",{"measure":75,"description":76,"timeFrame":77},"Participation rates","Acceptability will be assessed by participation rates.","Post-treatment (Week 10)",{"measure":79,"description":80,"timeFrame":77},"Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire","Acceptability will be assessed by measuring participant satisfaction with the intervention (including completion of the intervention) using the Client Satisfaction Questionnaire. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.",{"measure":82,"description":83,"timeFrame":77},"Telehealth acceptability specific to DBT skills training","A 41-item original survey developed by DBT experts in the United States and Australia to measure participants' satisfaction with DBT delivered through telehealth. Items designed to assess relevance of care experience on a 5-pt scale from Not Relevant to Very Relevant. Responses anonymized and qualitative free-text fields provided for recommendations and comments for changes or improvements.","FEMALE","18 Years","45 Years",false,{"inclusion":89,"exclusion":94,"raw_text":100},[90,91,92,93],"Emotion dysregulation score of 88 or above","At least 12 weeks pregnant","Singleton Pregnancy","Fluent in English",[95,96,97,98,99],"Active psychosis","Drug or alcohol use disorder during pregnancy","High risk of an imminent suicide attempt","Significant health complications (e.g., cancer)","Illiterate and\u002For unable to independently complete and comprehend written measures","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",[102],"ADULT",[104],{"facility":13,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":124},"Durham","North Carolina","27705","United States",[110,115,119,122],{"name":111,"role":112,"phone":113,"email":114},"Alicia Holloway","CONTACT","919-684-1333","adh60@duke.edu",{"name":116,"role":112,"phone":117,"email":118},"Janea Cato","(919) 684-3251","janea.cato@duke.edu",{"name":120,"role":121},"Elisabeth Conradt, PhD","PRINCIPAL_INVESTIGATOR",{"name":123,"role":121},"Andrada Neacsiu, PhD",{"lat":125,"lon":126},35.99403,-78.89862,[128,129],{"name":116,"role":112,"phone":117,"email":118},{"name":111,"role":112,"phone":130,"email":114},"(919) 684-1333",[132,133,134],{"name":120,"affiliation":13,"role":121},{"name":123,"affiliation":13,"role":121},{"name":135,"affiliation":136,"role":121},"Sheila Crowell, PhD","University of Oregon",[],[],{"nct_id":4,"conditions":140,"biomarkers":142},[141,22],"Emotional dysregulation",[],{"nct_id":4,"found":15,"summary":144,"prompt_version":154},{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is an interventional study planning to enroll 100 women. It is not specified if participants will be randomly assigned to different groups.","completed","DBT-P Treatment Study for Emotion Dysregulation in Pregnancy","This study is looking at whether a group program called DBT-P (Dialectical Behavior Therapy for Pregnancy) can help pregnant women better manage their emotions. DBT-P teaches emotional skills specifically for pregnancy and life with a new baby. Researchers want to see if improving these skills reduces stress and improves heart rate. You might be able to join if you are a woman between 18 and 45 years old, at least 12 weeks pregnant with one baby, speak English, and have a high score on a test for emotion dysregulation (88 or above). The study is currently unclear on its recruitment status. Success would mean participants show improved emotion regulation and heart rate.","The primary endpoints are measured at Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10).",112,"You would visit the clinic for 3 sessions: at the beginning, middle, and end of your pregnancy. You would complete surveys and interviews about your thoughts, feelings, and how you cope with emotions.","Not stated in the trial record.",[27],"v2"]