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

Not Applicable

Recruiting

• Conditions: Maternal Distress; Post Traumatic Stress Disorder; Dissociation; Maternal Behavior; Well-Being, Psychological; Mood Disturbance; Emotional Regulation; Maternal Care Patterns
• Interventions: Device: Neuroptimal (Zengar, Inc.) Neurofeedback

• Registration Number: NCT06054412
• Lead Sponsor: Wayne State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Start: 2024-03-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofeedback Training	Neuroptimal (Zengar, Inc.) Neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form	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.
The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children	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.
Patient Health Questionnaire 8	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.
Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.)	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.
Parenting Sense of Competence scale	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.
Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form	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.
The State Trait Anger Expression Inventory	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.
Parenting Stress Index	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.
The Crying Patterns Questionnaire	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.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard)	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.
Dissociative Experiences Scale II	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.

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States