DBT-P Treatment Study for Emotion Dysregulation in Pregnancy

This study is looking at whether a group program called DBT-P (Dialectical Behavior Therapy for Pregnancy) can help pregnant women better manage their emotions. DBT-P teaches emotional skills specifically for pregnancy and life with a new baby. Researchers want to see if improving these skills reduces stress and improves heart rate. You might be able to join if you are a woman between 18 and 45 years old, at least 12 weeks pregnant with one baby, speak English, and have a high score on a test for emotion dysregulation (88 or above). The study is currently unclear on its recruitment status. Success would mean participants show improved emotion regulation and heart rate.

Study design
This is an interventional study planning to enroll 100 women. It is not specified if participants will be randomly assigned to different groups.
What's involved
You would visit the clinic for 3 sessions: at the beginning, middle, and end of your pregnancy. You would complete surveys and interviews about your thoughts, feelings, and how you cope with emotions.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10).

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NCT06963801

DBT-P Treatment Study

Recruiting
NAAges 18–45InterventionalTreatment
Duke University
~100 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Moms2BDBT-P

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difficulties in Emotion Regulation Scale (DERS)
Measured over Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
+1 more outcome measured
Emotion Dysregulation
1 sites across 1 states
North Carolina1
  • Elisabeth Conradt, PhD · PRINCIPAL_INVESTIGATOR · Duke University
  • Andrada Neacsiu, PhD · PRINCIPAL_INVESTIGATOR · Duke University
  • Sheila Crowell, PhD · PRINCIPAL_INVESTIGATOR · University of Oregon

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Difficulties in Emotion Regulation Scale (DERS)Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

    The DERS is a 36-item measure scored on a 5-point Likert Scale. DERS scores range from 36-180 and enrollment in this study requires a baseline total DERS score of ≥88 which indicate greater difficulties in emotion regulation.

  • Respiratory Sinus Arrhythmia (RSA)Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

    RSA is a peripheral index of parasympathetic nervous system influences on cardiac activity and is measured as the variability in heart rate that coincides with respiration.