An interventional study of Neuroptimal (Zengar, Inc.) Neurofeedback in Well-Being, Psychological, Dissociation and Maternal Care Patterns, sponsored by Wayne State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Wayne State University · Not applicable, Interventional, and Other
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.
41 studies on the registry are indexed under Dissociative Disorders; 13 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 34 interventional studies indexed under Dissociative Disorders.
Browse Dissociative Disorders studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Compared within Dissociative Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form
To measure maternal well-being. Minimum score = 9 Maximum score = 45 Higher scores mean a better outcome.
Time frame: 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)
To measure maternal symptoms of PTSD Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
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.
Dissociative Experiences Scale II
To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
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.
Patient Health Questionnaire 8
To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
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 State Trait Anger Expression Inventory
To measure maternal anger control. Minimum score = 10 Maximum score = 40 Higher scores mean a worse outcome.
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.
Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.)
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.
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.
Parenting Stress Index
To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
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.
Parenting Sense of Competence scale
To measure feelings of parental competency and self-efficacy. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
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 Crying Patterns Questionnaire
To measure infant crying and fussing patterns. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
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 Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children
To measure infant psychosocial wellbeing. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
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.
Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form
To measure maternal emotional and behavioral self-regulation. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Time frame: Weekly, throughout the course of the 3-month intervention
Ran from Mar 2024 to primary completion in Sep 2025, 17 months.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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