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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: Completed NA study, sponsored by Emory University.
NCT03938350 is a NA study that has completed, run by Emory University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Feasibility of the intervention will be assessed by the number of women who agree to participate in the study, among those who are approached about participation.
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 |
What the finished NCT03938350 record still lists
NCT03938350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Dialectical Behavior Therapy (DBT) Skills Training is the first listed.
NCT03938350 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03938350's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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