DBT-P Treatment Study

Recruiting now · Not applicable

Conditions studied: Emotion Dysregulation

In brief

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.

Key facts

Study ID

NCT06963801

Run by

Duke University

People needed

100

Starts

2025-06-06

Expected to finish

2026-10-19

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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