Clinical trial NCT06963801: DBT-P Treatment Study
Official title: Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Dysregulation
Keywords: Emotion dysregulation
Pregnancy
Maternal health
RSA
Coping
Stress
DBT-P
Moms2B
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Oregon
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2025-05-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (18-22 weeks vs 23-27 weeks) as well as race and ethnicity.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Respiratory Sinus Arrhythmia (RSA)
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
Secondary outcomes:
measure: Percent of participation
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Percent of missing data
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Recruitment rates
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Reasons for refusal
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Intervention adherence
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Number of women who complete all sessions
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Number of interventionists who can self-monitor for fidelity, assessed by watching segments of video-recorded sessions
timeFrame: Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)
measure: Participation rates
timeFrame: Post-treatment (Week 10)
measure: Participant satisfaction with the intervention assessed by the Client Satisfaction Questionnaire
timeFrame: Post-treatment (Week 10)
measure: Telehealth acceptability specific to DBT skills training
timeFrame: Post-treatment (Week 10)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Elisabeth Conradt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Andrada Neacsiu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: Sheila Crowell, PhD
role: PRINCIPAL_INVESTIGATOR
References: