Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06963801

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

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Emotion dysregulation score of 88 or above
  • At least 12 weeks pregnant
  • Singleton pregnancy
  • Fluent in English
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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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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