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NCT06963801
DBT-P Treatment Study
Conditions: Emotion Dysregulation
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Duke University
Location: Duke University Durham North Carolina
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.
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
Source: ClinicalTrials.gov (NCT06963801). StuddyBuddy aggregates publicly available trial information.