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RECRUITING
NCT06963801
NA

DBT-P Treatment Study

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06-06

Completion Date

2026-10-19

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Moms2B

An established group-based pregnancy program focusing on improving nutrition, social, and medical support.

BEHAVIORAL

DBT-P

An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.

Locations (1)

Duke University

Durham, North Carolina, United States