DBT-P Treatment 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.

Conditions

• Emotion Dysregulation

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Oregon

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Elisabeth Conradt, PhD · Duke University

• Andrada Neacsiu, PhD · Duke University

• Sheila Crowell, PhD · University of Oregon

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-06

Primary Completion

2026-10-05

Completion

2026-10-19

Countries

• United States

Study Locations