DBT-P Treatment Study

Study acronym: REACH
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Oct 5, 2026 → Mar 5, 2027
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Record History

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  1. Primary completion pushed from Oct 5, 2026 to Mar 5, 2027 Show 5 more changesShow less
    • Study completion pushed from Oct 19, 2026 to Mar 19, 2027
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 4 of 10 entries
    • Site contact updated
    • Collaborators: details revised at 1 of 3 entries
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Dec 2026 to Oct 5, 2026
    • Study completion date: Jan 2027 to Oct 19, 2026
    • Site contact updated
    v4
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Jun 6, 2025
    • Site details revised
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duke University
457 trials monitored
See 58 trials at risk
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.
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
(from sponsor)		 Emotion Dysregulation
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov