Clinical Trial

DBT-P Treatment Study

Study acronym: REACH
Recruiting
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Summary
The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate. The main questions it aims to answer are: * Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope? * How is a participant's heart rate affected by their ability to control their emotions during pregnancy? Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate. Participants will: * Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy. * Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions. * Have their heart rate taken. * 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. * Optional Element: Complete a 20-30min infant neurobehavior exam (NNNS exam) after delivery.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-30; most recent amendment 2026-04-06.
Status change: Not Yet Recruiting → Recruiting 2025-06-11
Trial Details
NCT Number NCT06963801
Lead Sponsor Duke University
Collaborators: National Institute of Mental Health (NIMH), University of Oregon, Ann & Robert H Lurie Children's Hospital of Chicago
Conditions Emotion Dysregulation
Enrollment 100 participants
Start Date 2025-06-06
Primary Completion 2026-10-05 (estimated)
Study Completion 2026-10-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-08