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Active, Not Recruiting

NCT Number: NCT06054412

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Well-Being, Psychological Behavior Dissociation Dissociative Disorders Emotional Regulation Maternal Behavior Maternal Care Patterns Maternal Distress Mental Disorders Mood Disturbance Personal Satisfaction Post Traumatic Stress Disorder Psychological Well-Being Self-Control Social Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2023
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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