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

Last updated: July 14, 2025
Sponsor: Wayne State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Mood Disorders

Emotional Processing

Treatment

Neuroptimal (Zengar, Inc.) Neurofeedback

Clinical Study ID

NCT06054412
IRB-23-02-5477
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have clinically concerning symptoms of Post-traumatic Stress Disorder and/orit's dissociative sub-type, as indicated by either a score of 3+ on the Primary CarePTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsementof 2 or more past-month symptoms of moderate or greater severity on thedepersonalization/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 aclinic in the Greater Detroit area.

Exclusion

Exclusion Criteria:

  • Are currently pregnant

  • Have a lifetime history of significant untreated mental illness (not currentlytreated schizophrenia, schizoaffective disorder, bipolar disorder, or substance usedisorder) 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 statethat their current living conditions are unsafe

  • Are currently experiencing psychosis or have been suicidal within the last sixmonths

  • Are currently taking, or in the past month has taken benzodiazepines, narcoticdrugs, or cannabis

  • Have engaged in self-harming behaviors in the last 3 months requiring medicalattention

  • Do not have competence to understand or consent to the study procedures

  • Do not have fluency in written and spoken English

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Neuroptimal (Zengar, Inc.) Neurofeedback
Phase:
Study Start date:
March 03, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Wayne State University

    Detroit, Michigan 48202
    United States

    Active - Recruiting

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