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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 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 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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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.

Interventions

  • DEVICE Neurofeedback (MUSE 2)

Study Locations (1)

Michigan

  • Wayne State University School of Social Work - Detroit

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-02-13
Est. Completion 2025-12
Phase NA

Sponsor

Wayne State University

163 total trials

What the Registry Record Tells You About NCT05474534

The ClinicalTrials.gov registry entry for NCT05474534 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower). The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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