DBT-P Treatment Study

NCT06963801 | Recruiting DMC

• 2 other identifiers: Pro00116252R61MH138444
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Difficulties in Emotion Regulation Scale (DERS)

  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.

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

• Respiratory Sinus Arrhythmia (RSA)

  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.

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

Secondary Outcomes (10)

• Percent of participation

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

• Percent of missing data

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

• Recruitment rates

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

• Reasons for refusal

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

• Intervention adherence

  Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)

Study Arms (2)

Moms2B

ACTIVE COMPARATOR

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.

Behavioral: Moms2B

DBT-P

EXPERIMENTAL

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.

Behavioral: Moms2B; Behavioral: DBT-P

Interventions

Moms2B BEHAVIORAL

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

DBT-P; Moms2B

DBT-P BEHAVIORAL

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

DBT-P

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Oregon: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Study Officials

• Elisabeth Conradt, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Andrada Neacsiu, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Sheila Crowell, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janea Cato

CONTACT

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

Alicia Holloway

CONTACT

(919) 684-1333; adh60@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Clinical Research Coordinators collecting the data and conducting semi-structured emotion regulation interview.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: control group is assessment only and treatment group is DBT-P group sessions (emotional skills regulation groups). Groups stratified based on gestational age (14-20 weeks vs 21-27 weeks) as well as race and ethnicity.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)