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

NCT ID: NCT06054412

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-03

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Well-Being, Psychological Dissociation Maternal Care Patterns Maternal Behavior Maternal Distress Mood Disturbance Emotional Regulation Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Neuroptimal (Zengar, Inc.) Neurofeedback

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Lisa S. Panisch, PhD, MSW

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-23-02-5477

Identifier Type: -

Identifier Source: org_study_id