Recruiting

DBT-P

Sponsor:

Duke University

Code:

NCT06963801

Conditions

Emotion Dysregulation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Moms2B

DBT-P

Study Details

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.

Conditions

Emotion Dysregulation

Study ID

NCT06963801

Start date

Jun 6, 2025

Status verified date

Apr, 2026

Completion date

Oct 19, 2026

Anticipated

Primary completion date

Oct 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Moms2B

Moms2B is an established group-based intervention for pregnant women focused on enhancing social support and improving nutrition. Participants will receive 3 sessions using this established assessment only treatment plan as well as complete surveys and clinical interviews assessing stress, coping strategies and emotions. Resting heart rate data as well as heart rate data post stimulus to be assessed.

experimental: DBT-P

DBT-P is a Dialectical Behavior Therapy skills group adapted for pregnant people. Participants will receive weekly DBT-P group sessions for 10 weeks where they learn skills to: (1) enhance self-awareness; (2) improve ability to manage crises; (3) decrease negative emotions and increase positive emotions; (4) improve your relationships and self-respect; they will also complete homework as part of the group participation as well as complete daily diary cards that will ask about their mood and any thoughts of self-harm .

Completion of surveys and clinical interviews assessing stress, coping strategies and emotions are included; resting heart rate data as well as heart rate data post stimulus to be assessed.

Interventions

Moms2B

An established group-based pregnancy program focusing on improving nutrition, social, and medical support.

DBT-P

An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.

Primary outcome measure

  • Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10) ]
  • Respiratory Sinus Arrhythmia (RSA) [ Time Frame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10) ]

Central Contacts and Locations

Central contacts

Janea Cato

(919) 684-3251janea.cato@duke.edu

Alicia Holloway

(919) 684-1333adh60@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Alicia Holloway

919-684-1333adh60@duke.edu

Janea Cato

(919) 684-3251janea.cato@duke.edu

Principal Investigator:

Elisabeth Conradt, PhD

More Information

Sponsor

Duke University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • Emotion dysregulation
  • Pregnancy
  • Maternal health
  • RSA
  • Coping
  • Stress
  • DBT-P
  • Moms2B

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-08.