Mobile neurofeedback intervention for new mothers with trauma exposure
Beyond the Baby Blues: A Pilot Intervention to Enhance Well-Being in Trauma Exposed New Mothers
This study is testing a mobile neurofeedback program to see if it can help new mothers who have experienced trauma feel better and improve their parenting skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wayne State University Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05474534 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial evaluates the feasibility and effectiveness of a mobile neurofeedback intervention aimed at enhancing the well-being of postpartum mothers who have experienced trauma. The study focuses on measuring reductions in trauma symptoms, parenting stress, and improvements in emotional regulation and parenting behaviors. Participants will use the MUSE 2 neurofeedback device to potentially improve their mental health and parenting competency, while also assessing the impact on their infants' socio-emotional development. The trial compares outcomes between mothers receiving the intervention and those in a control group.
Who should consider this trial
Good fit: Ideal candidates are postpartum mothers aged 3-9 months with a history of trauma and PTSD symptoms.
Not a fit: Patients with significant untreated mental illness, neurological disorders, or a history of epilepsy may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and parenting skills of trauma-exposed new mothers, benefiting both them and their infants.
How similar studies have performed: While the specific approach of mobile neurofeedback is relatively novel, similar interventions targeting maternal mental health have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The inclusion criteria for mothers will be 1) a score of 2+ on the Adverse Childhood Experiences measure for childhood trauma exposure; 2) 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); 3) having a child who is between the ages of 3-9 months old; 3) having a personal phone or tablet device that is compatible with the MUSE 2 neurofeedback device. Exclusion Criteria: * Mothers and their infants will be excluded if mothers 1) have a lifetime history of significant untreated mental illness, neurological or pervasive developmental disorders; 2) have a documented history of epilepsy; 3) ever experienced previous head injury with loss of consciousness; 4) are currently experiencing intimate partner violence or otherwise state that their current living conditions are unsafe; 5) are currently experiencing psychosis or have been suicidal within the last six months; 6) are currently taking, or in the past month have taken benzodiazepines, narcotic drugs, or cannabis; 7) have engaged in self-harming behaviors in the last 3 months requiring medical attention; 8) are pregnant; 9) are current students at Wayne State University or have plans to enroll as a student at Wayne State University anytime in the next 12 months; 10) do not have competence to understand or consent/assent to the study procedures; or 11) do not have fluency in written and spoken English.
Where this trial is running
Detroit, Michigan
- Wayne State University School of Social Work — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Lisa S Panisch, PhD
- Email: Lisa.panisch@wayne.edu
- Phone: 313-577-4409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.