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NCT05474534 · ClinicalTrials.gov registry record · NA
An Intervention to Enhance Well-Being in Trauma Exposed New Mothers
A NA study of Post Traumatic Stress Disorder and Maternal Behavior, sponsored by Wayne State University.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05474534: Active NA study of Post Traumatic Stress Disorder and Maternal Behavior, sponsored by Wayne State University.
NCT05474534 is a NA study of Post Traumatic Stress Disorder and Maternal Behavior that is active but no longer recruiting, run by Wayne State University. The registered enrollment target is 40 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05474534, a NA study of Post Traumatic Stress Disorder and Maternal Behavior, is active but no longer recruiting, sponsored by Wayne State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.
Primary Outcome
The Post-Traumatic Stress Disorder Checklist for DSM-5 - Standard will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-80, with higher scores indicating worse outcomes, i.e., a greater severity of symptoms.
Conditions Studied
Interventions
- DEVICE Neurofeedback (MUSE 2)
Study Locations (1)
Michigan
- Wayne State University School of Social Work - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2025-12 |
| Phase | NA |
What the registry record for NCT05474534 still lists
NCT05474534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower).
The record links to 8 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Neurofeedback (MUSE 2) is the first listed.
NCT05474534 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05474534 about?
NCT05474534 is a clinical study titled "An Intervention to Enhance Well-Being in Trauma Exposed New Mothers". This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in reg...
What is the current status of trial NCT05474534?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2023-02-13. Estimated completion is 2025-12.
What conditions does trial NCT05474534 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Maternal Behavior, Emotional Regulation, Maternal Care Patterns, Infant Behavior.
What interventions are being tested in trial NCT05474534?
The interventions under investigation include: Neurofeedback (MUSE 2) (DEVICE).
Who is sponsoring clinical trial NCT05474534?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05474534 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05474534's enrollment target sits among peer trials
40 187th of 262 higher than 65 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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.
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