DBT-P Treatment Study
ConditionEmotion Dysregulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Emotion dysregulation score of 88 or above
At least 12 weeks pregnant
Singleton Pregnancy
Fluent in English
Disqualifiers
Active psychosis
Drug or alcohol use disorder during pregnancy
High risk of an imminent suicide attempt
Significant health complications (e.g., cancer)
Trial design
Design model
Parallel
Treatments tested in this trial
Moms2B
BehavioralAn established group-based pregnancy program focusing on improving nutrition, social, and medical support.
DBT-P
BehavioralAn emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Moms2BActive comparator 1 intervention
Group B: DBT-PExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)2
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.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)Secondary outcomes
1
Percent of participation
Feasibility of the assessment schedule will include the percent of participation at all timepoints.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)2
Percent of missing data
Feasibility of the assessment schedule will include the percent of missing data at all time points.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)3
Recruitment rates
Feasibility of the intervention will be assessed by evaluating recruitment rates.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)4
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.
Time frame
Baseline (Week 0), mid-treatment (Week 5), and post-treatment (Week 10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of Oregon
Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator
Source ClinicalTrials.gov