Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-06-06
2027-01-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Moms2B
An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
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.
Moms2B
An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
DBT-P
An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.
Interventions
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Moms2B
An established group-based pregnancy program focusing on improving nutrition, social, and medical support.
DBT-P
An emotional skills group where emotion regulation skills are taught in the context of the pregnancy and expected life with an infant.
Eligibility Criteria
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Inclusion Criteria
* At least 12 weeks pregnant
* Singleton Pregnancy
* Fluent in English
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Oregon
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Elisabeth Conradt, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Andrada Neacsiu, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Sheila Crowell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oregon
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Alicia Holloway
Role: primary
Janea Cato
Role: backup
Other Identifiers
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Pro00116252
Identifier Type: -
Identifier Source: org_study_id