DBT-P program to help pregnant people manage strong emotions
Official title: Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health
Run by Duke University · NCT06963801 · Data updated 2026-11-12
This study will see if a 10-week remote DBT skills program for pregnant people with emotion dysregulation can reduce stress and improve heart-rate regulation during pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | June 6, 2025 |
| Main results expected | January 11, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06963801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People who are at least 12 weeks pregnant with a singleton pregnancy, fluent in English, and who score 88 or higher on an emotion dysregulation measure are ideal candidates.
✕Probably not a fit
People with active psychosis, a current drug or alcohol use disorder during pregnancy, imminent high suicide risk, major medical complications, or who cannot complete written measures are excluded and unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant participants with high emotion dysregulation scores are enrolled and complete clinic visits early, mid, and late in pregnancy for surveys, interviews, and heart-rate measures. Participants assigned to the intervention will join weekly remote DBT-P emotion-regulation skills groups for 10 weeks and complete daily mood and coping diary cards, while others receive usual care. The study compares changes in self-reported emotion regulation, stress and physiological markers (heart rate/RSA) across pregnancy and into the postpartum period. The investigators aim to determine whether targeting skill use in pregnancy improves postpartum maternal mental health and newborn neurobehavior.
Why it matters
Potential benefit: If successful, the program could lower maternal stress, improve heart-rate regulation, and support better postpartum mental health and early mother–infant co-regulation.
How similar studies have gone: DBT skills interventions have shown benefits for emotion dysregulation in non-pregnant adults, but adapting and testing DBT specifically during pregnancy is relatively new.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Elisabeth Conradt, PhD — Duke University
- Study coordinator: Janea Cato
- Email: janea.cato@duke.edu
- Phone: (919) 684-3251
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.