An interventional study of Neurofeedback (MUSE 2) in Post-traumatic Stress Disorder, Dissociation and Maternal Care Patterns, sponsored by Wayne State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 40 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mothers in the treatment group will complete pre- and post-treatment self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in the treatment group will be provided with a wearable neurofeedback device called the MUSE 2, to use at home for 4-6 10-minute sessions per week, over the course of 3 months. Mothers in the treatment group will complete weekly virtual surveys assessing emotional and behavioral self-regulation capacities (e.g., anger control, etc.) throughout the 3 month duration of this study phase. Mothers in the treatment group will also answer additional weekly questions about intervention uptake (i.e., no. of sessions completed in the past week) and feasibility (i.e.,barriers to treatment uptake, ease of use of the device, etc.).
Device: Neurofeedback (MUSE 2)
Mothers in the wait-list control group will complete pre- and post-treatment self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in the wait-list control group will complete weekly virtual surveys assessing emotional and behavioral self-regulation capacities (e.g., anger control, etc.) throughout the 3 month duration of this study phase.
During each at-home treatment session, mothers will place the MUSE 2 on their heads and connect it to the app on their personal device. Their brain activity is monitored by the MUSE 2 and is represented on the app through audio-based feedback (e.g., birds chirping, sounds of waves lapping on the beach) that mothers will listen to with earbuds as they direct their focus on maintaining a calm state of mind during the session; when a calm state is maintained, they are rewarded with calming sounds. The goal is to gain increased conscious control over their own brain activity. The audio feedback, primarily composed of nature-based sounds, is meant to guide their brain activity into a calm state. The session will begin, and the MUSE 2 will provide audio feedback in real time to guide their brainwave activity into an optimal frequency bandwidth range (e.g., as their brain activity reaches the target state, sounds of wind would subside to peaceful waves or other rewarding audio feedback).
Change from Baseline Maternal PTSD Symptoms at 3 Months
The Post-Traumatic Stress Disorder Checklist for DSM-5 - Standard will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-80, with higher scores indicating worse outcomes, i.e., a greater severity of symptoms.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Maternal Dissociative Symptoms at 3 Months
The Dissociative Experiences Scale II will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-100, with higher scores indicating worse outcomes, i.e., more dissociative symptoms.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Maternal Symptoms of Parenting Stress at 3 Months
The Parenting Stress Index 4 - Short Form will be administered to participants at baseline and again after the intervention has concluded 3 months later. Overall stress scores range from 36-180, with higher scores indicating worse outcomes, i.e., more stress.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Parental Sense of Competency and Self-Efficacy at 3 Months
The Parenting Sense of Competence scale will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 17-102, with higher scores indicating better outcomes, i.e., a greater sense of parenting competency.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Maternal Risk of Child Abuse at 3 Months
The Brief Child Abuse Potential measure will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-34, with higher scores indicating worse outcomes, i.e., greater risk of child abuse.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Maternal Depressive Symptoms at 3 Months
The Patient Health Questionnaire 8 will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-24, with higher scores indicating worse outcomes, i.e., more depressive symptoms.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Maternal Anger Control at 3 Months
The Trait Anger Scale of the State Trait Anger Expression Inventory will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 10-40, with higher scores indicating worse outcomes, i.e., less anger control.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Weekly Changes of Maternal Emotional and Behavioral Self-Regulation Across 12 Weeks
The Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form will be administered to participants one time a week for 12 weeks (across the course of the 12-week intervention). Scores range from 8-40, with higher scores indicating worse outcomes, i.e., less anger control.
Time frame: Weekly, throughout the course of the 3-month intervention (across 12 weeks)
Weekly Changes of Maternal Positive Affect and Well-Being Across 12 Weeks
The Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form will be administered to participants one time a week for 12 weeks (across the course of the 12-week intervention). Scores range from 9-45, with higher scores indicating better outcomes, i.e., greater positive affect and well-being.
Time frame: Weekly, throughout the course of the 3-month intervention (across 12 weeks)
Change from Baseline Infant Crying and Fussing Patterns at 3 Months
The Crying Patterns Questionnaire will be administered to participants at baseline and again after the intervention has concluded 3 months later. There is no formal scale for this measure. The amount of hours an infant spends crying/fussing at different timepoints throughout the day over the course of are evaulated to indicate crying/fussing patterns.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Change from Baseline Infant Psychosocial Well-Being at 3 Months
The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children will be administered to participants at baseline and again after the intervention has concluded 3 months later. Scores range from 0-24, with higher scores indicating worse outcomes, i.e., more psychosocial concerns.
Time frame: Baseline and Post-intervention Assessments (intervention lasts 3 months)
Ran from Feb 2023 to primary completion in Sep 2025, 30 months.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 30 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →