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NCT06963801 · ClinicalTrials.gov registry record · NA
DBT-P Treatment Study
A NA study of Emotion Dysregulation, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06963801: Recruiting NA study of Emotion Dysregulation, sponsored by Duke University.
NCT06963801 is a NA study of Emotion Dysregulation that is actively recruiting participants, run by Duke University. The registered enrollment target is 100 participants, above the 85-participant average among 3 other Emotion Dysregulation trials with a reported enrollment target (18% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06963801, a NA study of Emotion Dysregulation, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Moms2B
- BEHAVIORAL DBT-P
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-06 |
| Est. Completion | 2026-10-19 |
| Phase | NA |
What NCT06963801 shows while recruiting
NCT06963801 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 3 other Emotion Dysregulation trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Emotion Dysregulation appearing as the primary indexed condition, and to 2 interventions - of which Moms2B is the first listed.
NCT06963801 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06963801 about?
NCT06963801 is a clinical study titled "DBT-P Treatment Study". 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? * ...
What is the current status of trial NCT06963801?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-06-06. Estimated completion is 2026-10-19.
What conditions does trial NCT06963801 study?
This clinical trial studies the following conditions: Emotion Dysregulation.
What interventions are being tested in trial NCT06963801?
The interventions under investigation include: Moms2B (BEHAVIORAL), DBT-P (BEHAVIORAL).
Who is sponsoring clinical trial NCT06963801?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06963801 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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