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

Primary Purpose

Well-Being, Psychological, Dissociation, Maternal Care Patterns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuroptimal (Zengar, Inc.) Neurofeedback
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Well-Being, Psychological

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Neurofeedback Training

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Dissociative Experiences Scale II
    To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
    Patient Health Questionnaire 8
    To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
    The State Trait Anger Expression Inventory
    To measure maternal anger control. Minimum score = 10 Maximum score = 40 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 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 Stress Index
    To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
    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 Crying Patterns Questionnaire
    To measure infant crying and fussing patterns. 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
    To measure infant psychosocial wellbeing. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Wayne State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06054412
    Brief Title
    An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
    Official Title
    Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wayne State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Well-Being, Psychological, Dissociation, Maternal Care Patterns, Maternal Behavior, Maternal Distress, Mood Disturbance, Emotional Regulation, Post Traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neurofeedback Training
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Neuroptimal (Zengar, Inc.) Neurofeedback
    Intervention Description
    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 Outcome Measure Information:
    Title
    Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form
    Description
    To measure maternal well-being. Minimum score = 9 Maximum score = 45 Higher scores mean a better outcome.
    Time Frame
    Weekly, throughout the course of the 3-month training phase
    Title
    Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard)
    Description
    To measure maternal symptoms of PTSD Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    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.
    Title
    Dissociative Experiences Scale II
    Description
    To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
    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.
    Title
    Patient Health Questionnaire 8
    Description
    To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
    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.
    Title
    The State Trait Anger Expression Inventory
    Description
    To measure maternal anger control. Minimum score = 10 Maximum score = 40 Higher scores mean a worse outcome.
    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.
    Title
    Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.)
    Description
    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.
    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.
    Title
    Parenting Stress Index
    Description
    To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
    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.
    Title
    Parenting Sense of Competence scale
    Description
    To measure feelings of parental competency and self-efficacy. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    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.
    Title
    The Crying Patterns Questionnaire
    Description
    To measure infant crying and fussing patterns. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    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.
    Title
    The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children
    Description
    To measure infant psychosocial wellbeing. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    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.
    Title
    Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form
    Description
    To measure maternal emotional and behavioral self-regulation. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
    Time Frame
    Weekly, throughout the course of the 3-month intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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