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

NCT06054412 | Active Not Recruiting FDA Device

• 1 other identifier: IRB-23-02-5477
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Weekly, throughout the course of the 3-month intervention

Study Arms (1)

Neurofeedback Training

OTHER

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

Interventions

Neuroptimal (Zengar, Inc.) Neurofeedback DEVICE

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.

Neurofeedback Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Psychological Well-Being; Dissociative Disorders; Emotional Regulation; Stress Disorders, Post-Traumatic

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Self-Control; Social Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 26, 2023
• Study Start: March 3, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)