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RECRUITING Not applicable ClinicalTrials.gov

DBT-P Treatment Study

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06963801

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Moms2B (Behavioral)
    An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
  • DBT-P (Behavioral)
    An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.

Eligibility criteria

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

Conditions

Emotion Dysregulation

Locations

  • Duke University — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record