Well-Being, PsychologicalNCT06054412
An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
A study testing Neuroptimal (Zengar, Inc.) Neurofeedback in people with Well-Being, Psychological and Dissociation, run by Wayne State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Well-Being, Psychological, Dissociation, Maternal Care Patterns
- What is being tested?
- Neuroptimal (Zengar, Inc.) Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure
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.
- Conditions
- Well-Being, Psychological, Dissociation, Maternal Care Patterns, Maternal Behavior, Maternal Distress, Mood Disturbance
- Being tested
- Neuroptimal (Zengar, Inc.) Neurofeedback
- Medical subject headings
- Psychological Well-Being, Dissociative Disorders, Emotional Regulation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroptimal (Zengar, Inc.) NeurofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback Training | Other | 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. Receives: Device: Neuroptimal (Zengar, Inc.) Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly, throughout the course of the 3-month training phase
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.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Dissociative Experiences Scale II
To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Patient Health Questionnaire 8
To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
Measured: 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 State Trait Anger Expression Inventory
To measure maternal anger control. Minimum score = 10 Maximum score = 40 Higher scores mean a worse outcome.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
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.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Parenting Stress Index
To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
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.
Measured: 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 Crying Patterns Questionnaire
To measure infant crying and fussing patterns. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Measured: 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 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.
Measured: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
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.
Measured: Weekly, throughout the course of the 3-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start3 Mar 2024
- Primary completion1 Sep 2025
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa S. Panisch, PhD, MSW, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054412
- Sponsor's protocol ID
- IRB-23-02-5477
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure
- ClinicalTrials.gov ID
- NCT06054412
- Acronym / sponsor ID
- IRB-23-02-5477
- Conditions
- Well-Being, Psychological, Dissociation, Maternal Care Patterns, Maternal Behavior, Maternal Distress, Mood Disturbance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Training | Other | Device: Neuroptimal (Zengar, Inc.) NeurofeedbackMothers 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroptimal (Zengar, Inc.) NeurofeedbackMothers 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. | Device | Neurofeedback Training |
Primary outcome
Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form
Time frame: 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.
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard)
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.
To measure maternal symptoms of PTSD Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.
Dissociative Experiences Scale II
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.
To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome.
Patient Health Questionnaire 8
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.
To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome.
The State Trait Anger Expression Inventory
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.
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.)
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.
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
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.
To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome.
Parenting Sense of Competence scale
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.
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
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.
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
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.
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroptimal (Zengar, Inc.) Neurofeedback in people with Well-Being, Psychological and Dissociation, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form (time frame: Weekly, throughout the course of the 3-month training phase). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.