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An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

NCT06054412 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-12

No results posted yet for this study

Summary

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

Conditions

  • Well-Being, Psychological
  • Dissociation
  • Maternal Care Patterns
  • Maternal Behavior
  • Maternal Distress
  • Mood Disturbance
  • Emotional Regulation
  • Post Traumatic Stress Disorder

Interventions

DEVICE

Neuroptimal (Zengar, Inc.) Neurofeedback

Mothers in the Neurofeedback Training group will complete one training session (lasting approximately 33 minutes) a week for a total of 12 weeks, using the Neuroptimal (Zengar, Inc.) neurofeedback device.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-03
Primary Completion
2025-09-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054412 on ClinicalTrials.gov