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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054412
• Other study ID #: IRB-23-02-5477
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Wayne State University
• Contact: Principal Investigator
• Phone: 313-577-4409
• Email: hj1429[@]wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dissociation
• Dissociative Disorders
• Emotional Regulation
• Maternal Behavior
• Maternal Care Patterns
• Maternal Distress
• Mood Disturbance
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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