| NCT ID | NCT06963801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Emotion Dysregulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2027-01-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-06-06 with a primary completion date of 2027-01-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Elisabeth Conradt, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06963801 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Emotion Dysregulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06963801 currently recruiting?
Yes, NCT06963801 is actively recruiting participants. Contact the research team at janea.cato@duke.edu for enrollment information.
Where is the NCT06963801 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06963801 clinical trial?
NCT06963801 is sponsored by Duke University. The principal investigator is Elisabeth Conradt, PhD at Duke University. The trial plans to enroll 100 participants.