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Behavioural Intervention

Neurofeedback for Traumatic Stress Disorders in New Mothers

N/A

Recruiting

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly, throughout the course of the 3-month intervention (across 12 weeks)

Awards & highlights

Study Summary

This trial evaluates whether a mobile neurofeedback intervention can reduce trauma symptoms and improve parenting in postpartum mothers, as well as infant socio-emotional development and behavior.

Who is the study for?

This trial is for new mothers who have experienced childhood trauma or show symptoms of PTSD, with a child aged 3-9 months. They must own a compatible device for the neurofeedback tool and not have untreated mental illness, epilepsy, recent head injury, current unsafe living conditions, psychosis or suicidal tendencies in the last six months.Check my eligibility

What is being tested?

The study tests if using MUSE 2 neurofeedback can improve well-being in new mothers with trauma exposure. It looks at changes in their mental health, emotional regulation, parenting stress and behaviors as well as their infant's socio-emotional development compared to those without this intervention.See study design

What are the potential side effects?

While specific side effects are not listed for neurofeedback interventions like MUSE 2, typical concerns may include temporary discomfort from wearing the device or potential frustration if technical issues arise during use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly, throughout the course of the 3-month intervention (across 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly, throughout the course of the 3-month intervention (across 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly, throughout the course of the 3-month intervention (across 12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Infant Crying and Fussing Patterns at 3 Months

Change from Baseline Infant Psychosocial Well-Being at 3 Months

Change from Baseline Maternal Anger Control at 3 Months

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment1 Intervention

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 II: Wait-list Control GroupActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Wayne State UniversityLead Sponsor

307 Previous Clinical Trials

108,443 Total Patients Enrolled

1 Trials studying Maternal Care Patterns

20 Patients Enrolled for Maternal Care Patterns

Media Library

Mobile Neurofeedback Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05474534 — N/A

Maternal Care Patterns Research Study Groups: Treatment Group, Wait-list Control Group

Maternal Care Patterns Clinical Trial 2023: Mobile Neurofeedback Intervention Highlights & Side Effects. Trial Name: NCT05474534 — N/A

Mobile Neurofeedback Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05474534 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still slots available for enrolment in this experiment?

"As evidenced by the clinicaltrials.gov listing, this medical trial is actively looking for patients to enroll. The study was first announced on January 1st 2023 and has had recent updates as of April 24th 2023."

Answered by AI

How many patients are presently participating in this scientific experiment?

"Affirmative. Clinicaltrial.gov's records show that this research project, which was posted on the 1st of January 2023, is still recruiting participants. The experiment demands 40 volunteers from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lisa S. Panisch, PhD, MSW 2023. "An Intervention to Enhance Well-Being in Trauma Exposed New Mothers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05474534.