DBT-P Treatment Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

Emotion dysregulation score of 88 or above

At least 12 weeks pregnant

Singleton Pregnancy

Fluent in English

Disqualifiers

Active psychosis

Drug or alcohol use disorder during pregnancy

High risk of an imminent suicide attempt

Significant health complications (e.g., cancer)

Trial design

Treatments tested in this trial

  • Moms2B
  • DBT-P

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of Oregon

Collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator