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DBT-P Treatment Study

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

Who can join

Ages 18 to 45 · Women

Inclusion Criteria:

* Emotion dysregulation score of 88 or above
* At least 12 weeks pregnant
* Singleton Pregnancy
* Fluent in English

Exclusion Criteria:

* Active psychosis
* Drug or alcohol use disorder during pregnancy
* High risk of an imminent suicide attempt
* Significant health complications (e.g., cancer)
* Illiterate and/or unable to independently complete and comprehend written measures

About the 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? * 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.

What is being tested

• Moms2B (behavioral)
• DBT-P (behavioral)

Sponsor: Duke University · Participants: 100 · Started: Jun 6, 2025

Contact the study team

• Janea Cato · Phone: (919) 684-3251
• Alicia Holloway · Phone: (919) 684-1333

Official record on ClinicalTrials.gov — NCT06963801

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.