DBT-P Treatment Study (REACH)

Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health

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.

Study Overview

• Status: Recruiting
• Conditions: Emotion Dysregulation
• Intervention / Treatment: Behavioral: Moms2B; Behavioral: DBT-P

Detailed Description

The investigators' observational research with mothers with emotion dysregulation and their infants shows that poor emotion regulation skill use is a mechanism that likely confers risk for self-injurious thoughts and behaviors, depression, and anxiety in the mother and neurobehavioral and co-regulatory challenges in the infant. Emotion dysregulation is an impairing, early-emerging, transdiagnostic vulnerability factor that has intergenerational implications. Treatments have been developed for non-pregnant adults with emotion dysregulation but these are costly, time-intensive, and do not address the unique needs of pregnant people, highlighting an unmet therapeutic need. Through this innovative intervention, researchers will test whether targeting emotion regulation skills use during pregnancy will both improve postpartum emotion regulation, newborn neurobehavior, and mother-infant co-regulation. Early identification of the mechanisms implicated in risk. The researchers will deliver 10 weeks of DBT skills classes selected and adapted to meet the unique needs of pregnancy (DBT-P). The goal of this work is to improve perinatal mental health trajectories.

The premise of this study-that improving emotion regulation in pregnancy may disrupt intergenerational transmission of psychopathology-is informed by our research over the past two decades, including several NIH awards (R01MH119070, R01MH132210, R01DA049755, R21MH1090777, F31MH074196). The investigator' data reveal that maternal emotion dysregulation confers risk for mother. The research also shows that resting respiratory sinus arrhythmia (RSA), a physiological index of emotion dysregulation, can be improved via intervention in non-pregnant adults. The investigators propose that DBT-P will increase emotion regulation skills use or increase RSA in the mother (target engagement) leading to significant reductions in her emotion dysregulation prior to birth.

The primary study objectives are to recruit 100 pregnant women with high emotion dysregulation to receive either: (1) dialectical behavior therapy skills groups or an Assessment only control; and (2) to evaluate whether the treatment improved emotion regulation skills use as well as respiratory sinus arrhythmia.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Holloway; Phone Number: (919) 684-1333; Email: adh60@duke.edu
• Study Contact Backup: Name: Janea Cato; Phone Number: (919) 684-3251; Email: janea.cato@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Principal Investigator: Andrada Neacsiu, PhD
      • Contact: Alicia Holloway; Phone Number: 919-684-1333; Email: adh60@duke.edu
      • Principal Investigator: Elisabeth Conradt, PhD
      • Contact: Janea Cato; Phone Number: (919) 684-3251; Email: janea.cato@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Moms2B; An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
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.	Behavioral: Moms2B; An established group-based pregnancy program focusing on improving nutrition, social, and medical support.; Behavioral: DBT-P; An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participation	Feasibility of the assessment schedule will include the percent of participation at all timepoints.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Percent of missing data	Feasibility of the assessment schedule will include the percent of missing data at all time points.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Recruitment rates	Feasibility of the intervention will be assessed by evaluating recruitment rates.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Reasons for refusal	Feasibility of the intervention will be assessed by evaluating reasons for refusal. Collection of reasons for refusal to be obtained via subject self-report at each individual timepoint; expected attendance for 85% of sessions.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Intervention adherence	Feasibility of the intervention will be assessed by evaluating intervention adherence. Weekly assessment of intervention adherence conducted by clinicians based on subject completion of required homework assignments, daily diary entries and group session attendance.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of women who complete all sessions	Feasibility will be assessed by how many women completed all sessions.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions	Feasibility will be assessed by whether the interventionist can self-monitor for fidelity.	Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Participation rates	Acceptability will be assessed by participation rates.	Post-treatment (Week 10)
Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire	Acceptability will be assessed by measuring participant satisfaction with the intervention (including completion of the intervention) using the Client Satisfaction Questionnaire. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.	Post-treatment (Week 10)
Telehealth acceptability specific to DBT skills training	A 41-item original survey developed by DBT experts in the United States and Australia to measure participants' satisfaction with DBT delivered through telehealth. Items designed to assess relevance of care experience on a 5-pt scale from Not Relevant to Very Relevant. Responses anonymized and qualitative free-text fields provided for recommendations and comments for changes or improvements.	Post-treatment (Week 10)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of Oregon; National Institute of Mental Health (NIMH); Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Andrada Neacsiu, PhD, Duke University; Principal Investigator: Elisabeth Conradt, PhD, Duke University; Principal Investigator: Sheila Crowell, PhD, University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 19, 2026

Study Registration Dates

• First Submitted: April 30, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Pregnancy; Coping; RSA; Maternal health; Emotion dysregulation; DBT-P; Moms2B
• Other Study ID Numbers: Pro00116252; R61MH138444 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No