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NCT03938350 · ClinicalTrials.gov registry record · NA
Dialectical Behavior Therapy for Pregnant Women
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03938350 is a NA study that has completed, run by Emory University. The registered enrollment target is 30 participants.
The verdict
NCT03938350, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The cumulative effects of adverse childhood experiences (ACEs) can lead to prolonged activation of stress response systems, known as toxic stress. Toxic stress is increasingly recognized as an important contributor to socioeconomic and racial health disparities that emerge in early childhood and may persist across generations. African American women experience significant disparities in maternal and infant mortality, some of which may be attributable to toxic stress. The toxic stress response may increase risk factors for maternal and infant morbidity and mortality such as high-levels of stress hormones, high blood pressure, maternal PTSD and depression. Further, heightened maternal stress responses in pregnancy are associated with heightened infant stress responses, increasing the risk for the intergenerational transmission of toxic stress. Mindfulness-based interventions have demonstrated efficacy for a variety of mental health conditions, including depression and PTSD, are cost-effective, and scalable in diverse settings. Implementing mindfulness interventions for African American pregnant women with histories of ACEs and current depression and/or PTSD symptoms is novel and has the potential to interrupt the intergenerational cycle of toxic stress by improving maternal stress response and mental health. This study is a pilot, randomized controlled trial where participants will receive either Dialectical Behavior Therapy (DBT) Skills Training for 8 weeks (delivered virtually) or treatment as usual.
Interventions
- BEHAVIORAL Dialectical Behavior Therapy (DBT) Skills Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-16 |
| Est. Completion | 2022-09-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03938350
The ClinicalTrials.gov registry entry for NCT03938350 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dialectical Behavior Therapy (DBT) Skills Training is the first listed.
NCT03938350 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03938350 about?
NCT03938350 is a clinical study titled "Dialectical Behavior Therapy for Pregnant Women". The cumulative effects of adverse childhood experiences (ACEs) can lead to prolonged activation of stress response systems, known as toxic stress. Toxic stress is increasingly recognized as an important contributor to socioeconomic and racial health disparities that emerge in early childhood and may...
What is the current status of trial NCT03938350?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-10-16. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT03938350?
The interventions under investigation include: Dialectical Behavior Therapy (DBT) Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT03938350?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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