An Intervention to Enhance Well-Being in Trauma Exposed New Mothers

NCT ID: NCT05474534

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Post-traumatic Stress Disorder; Dissociation; Maternal Care Patterns; Infant Behavior; Maternal Behavior; Maternal Distress; Mood Disturbance; Emotional Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

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.).

Group Type: EXPERIMENTAL

Neurofeedback (MUSE 2)

Intervention Type: DEVICE

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).

Wait-list Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neurofeedback (MUSE 2)

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Lisa S. Panisch, PhD, MSW

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wayne State University School of Social Work

Detroit, Michigan, United States

Countries

United States

Other Identifiers

Protocol # IRB-22-04- 4542

Identifier Type: -

Identifier Source: org_study_id