DBT-P Treatment Study

Conditions

• Emotion Dysregulation

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Not accepted

Interventions

• Moms2B — BEHAVIORAL
  An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
• 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.

Study Details

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.

Key Dates

Start date

Jun 6, 2025

Status verified

Apr 2026

Primary completion

Oct 5, 2026

Completion

Oct 19, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Janea Cato
  (919) 684-3251
  [email protected]
• Alicia Holloway
  (919) 684-1333
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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