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

November 10, 2025 updated by: Lisa S. Panisch, PhD, MSW, Wayne State University

Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have clinically concerning symptoms of Post-traumatic Stress Disorder and/or it's dissociative sub-type, as indicated by either a score of 3+ on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the Dissociative Subtype of PTSD Scale (DSPS).
  • Must be between 3-24 months postpartum
  • Must be receiving regular, primarily in-person psychotherapy from a therapist at a clinic in the Greater Detroit area.

Exclusion Criteria:

  • Are currently pregnant
  • Have a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder
  • Have a documented history of epilepsy
  • Have ever experienced previous head injury with loss of consciousness
  • Are currently experiencing domestic or intimate partner violence or otherwise state that their current living conditions are unsafe
  • Are currently experiencing psychosis or have been suicidal within the last six months
  • Are currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis
  • Have engaged in self-harming behaviors in the last 3 months requiring medical attention
  • Do not have competence to understand or consent to the study procedures
  • Do not have fluency in written and spoken English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Neurofeedback Training
Mothers in the Neurofeedback Training group will complete pre and post-training self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in this group will all be receiving in-person psychotherapy outside of the study, and they will all demonstrate clinically significant symptoms aligned with post-traumatic stress disorder and/or it's dissociative subtype.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form
Time Frame: Weekly, throughout the course of the 3-month training phase
To measure maternal well-being. Minimum score = 9 Maximum score = 45 Higher scores mean a better outcome.
Weekly, throughout the course of the 3-month training phase
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard)
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure maternal symptoms of PTSD Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Dissociative Experiences Scale II
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Patient Health Questionnaire 8
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
The State Trait Anger Expression Inventory
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure maternal anger control. Minimum score = 10 Maximum score = 40 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.)
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.

The Brief Child Abuse Potential is a screening tool that is an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.). This measure is used to understand a caregiver's potential risk of perpetrating acts of child abuse. The measure includes 33 items; caregiver's endorse whether they "Agree" or "Disagree" with each item. Agree responses are given a score of 1, Disagree responses are given a score of 0.

Minimum score = 0 Maximum score = 33 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Parenting Stress Index
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Parenting Sense of Competence scale
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure feelings of parental competency and self-efficacy. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
The Crying Patterns Questionnaire
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure infant crying and fussing patterns. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children
Time Frame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
To measure infant psychosocial wellbeing. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form
Time Frame: Weekly, throughout the course of the 3-month intervention
To measure maternal emotional and behavioral self-regulation. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Weekly, throughout the course of the 3-month intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2024

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-23-02-5477

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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