What side effects are associated with this type of intervention?

Neurofeedback and other noninvasive neuromodulation therapies, such as repetitive transcranial magnetic stimulation (TMS), are generally well-tolerated with minimal side effects. Common side effects may include mild headaches, scalp discomfort, or transient fatigue. In rare cases, individuals might experience dizziness or slight mood changes. These treatments are considered safe for most patients, but it is important to monitor for any adverse reactions and consult with a healthcare provider to ensure suitability.

What prior FDA approvals exist?

There are no specific FDA-approved neurofeedback interventions for maternal care patterns. However, treatments for maternal mental health, such as selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT), have been approved and are commonly used. These treatments aim to improve emotional regulation, reduce symptoms of depression and anxiety, and enhance overall well-being, which can positively impact parenting behaviors and outcomes.

What other types of research exist?

Promising alternatives to Mobile Neurofeedback Intervention for maternal care patterns include: 1) Cognitive Behavioral Therapy (CBT) for emotional regulation and mental health improvement, 2) Mindfulness-Based Stress Reduction (MBSR) for reducing stress and enhancing emotional regulation, 3) Acceptance and Commitment Therapy (ACT) for improving mental health and parenting behaviors, and 4) Internet-based interventions and mobile apps for mental health support and parenting education. These alternatives have shown effectiveness in various studies and could be considered for treatment in 2024.

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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

No Placebo-Only Group

Summary

This trial tests a mobile app that helps new mothers with PTSD manage their stress and improve their parenting skills. The goal is to see if this helps both the mothers' mental health and their babies' development.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neurofeedback, a common treatment for improving maternal care patterns, works by training individuals to regulate their brain activity through real-time feedback on brainwave patterns. This process enhances emotional regulation, reduces stress, and improves mental health. For mothers, these improvements can lead to more sensitive and positive parenting behaviors, which are essential for the socio-emotional development of their infants. Additionally, better mental health in mothers can decrease the potential for child maltreatment and enhance overall parenting competency, making it a valuable intervention for maternal care patterns.

Electronic behavioral interventions for headache: a systematic review.Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia.