Actively Recruiting
DBT-P Treatment Study
Led by Duke University · Updated on 2026-04-08
100
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DBT-P Treatment Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Emotion dysregulation score of 88 or above
- At least 12 weeks pregnant
- Singleton pregnancy
- Fluent in English
You will not qualify if you...
- Active psychosis
- Drug or alcohol use disorder during pregnancy
- High risk of an imminent suicide attempt
- Significant health complications such as cancer
- Illiterate or unable to independently complete and understand written measures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
J
Janea Cato
CONTACT
A
Alicia Holloway
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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