Neurofeedback for Traumatic Stress Disorders in New Mothers

Overseen By Lisa S Panisch, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Benzodiazepines, Narcotics, Cannabis

Disqualifiers: Untreated mental illness, Epilepsy, Unsafe living, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist new mothers dealing with post-traumatic stress disorder (PTSD). Researchers are testing a mobile neurofeedback device that helps users regulate brain activity to determine if it can improve mental health and parenting skills. Participants will use the device at home and report on their experiences and their infants' behavior. New mothers with PTSD symptoms, a history of childhood trauma, and a compatible device might be suitable candidates. The goal is to enhance maternal well-being and positively impact infant development. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new support methods for mothers and their infants.

Will I have to stop taking my current medications?

The trial requires that you have not taken benzodiazepines, narcotic drugs, or cannabis in the past month. If you are currently taking these medications, you would need to stop before participating.

What prior data suggests that this mobile neurofeedback intervention is safe for postpartum mothers?

Research shows that mobile neurofeedback can safely manage symptoms like PTSD (post-traumatic stress disorder). Studies have found that individuals can effectively use neurofeedback on their mobile devices independently. For instance, research involving veterans with PTSD and other conditions demonstrated their ability to use mobile neurofeedback on their own.

Another study found that neurofeedback improved cognitive control, which is the brain's ability to focus and manage behavior, in people with PTSD. This indicates the treatment was not only effective but also generally well-tolerated.

These studies have not reported serious negative effects, suggesting the treatment might be safe for managing symptoms. However, as this is an early-stage trial, more research is needed to confirm these findings for new mothers with traumatic stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mobile neurofeedback interventions for traumatic stress disorders in new mothers because they offer a unique, non-invasive way to help manage symptoms. Unlike traditional treatments like therapy and medication, this method uses a wearable device, the MUSE 2, to provide real-time feedback on brain activity, helping mothers regulate their emotions and stress levels from the comfort of their homes. This innovative approach not only empowers mothers to take control of their mental health but also fits seamlessly into their busy lives, potentially improving accessibility and adherence to treatment.

What evidence suggests that this neurofeedback intervention is effective for traumatic stress disorders in new mothers?

Research shows that neurofeedback, a type of brain training, can help reduce PTSD (post-traumatic stress disorder) symptoms. In this trial, participants in the treatment group will receive a Mobile Neurofeedback Intervention using a wearable device. Studies have found that neurofeedback aids in managing emotions and can improve related issues like depression and anxiety. This treatment is noninvasive, meaning it doesn't involve surgery or entering the body. Reviews of various studies suggest that neurofeedback significantly benefits PTSD symptoms. As more research emerges, evidence continues to support the advantages of this approach. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Mothers with a personal phone or tablet device that is compatible with the MUSE 2 neurofeedback device

Mothers with a score of 2+ on the Adverse Childhood Experiences measure for childhood trauma exposure

I am a mother with a child aged 3-9 months.

Exclusion Criteria

I have used benzodiazepines, narcotics, or cannabis in the last month.

Mothers with a documented history of epilepsy

Pregnant mothers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers in the treatment group use a wearable neurofeedback device for 4-6 sessions per week over 3 months, with weekly virtual surveys assessing emotional and behavioral self-regulation.

12 weeks

Weekly virtual surveys

Follow-up

Participants are monitored for changes in maternal and infant outcomes post-intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Neurofeedback Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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 Group Active Control 1 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.

Mobile Neurofeedback Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurofeedback Therapy for:

• Anxiety
• Depression
• PTSD
• ADHD
• Trauma

Approved in European Union as Neurofeedback Therapy for:

• Anxiety
• Depression
• PTSD
• ADHD
• Sleep Disorders

Approved in Canada as Neurofeedback Therapy for:

• Anxiety
• Depression
• PTSD
• ADHD
• Chronic Stress

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Published Research Related to This Trial

In a study of 52 individuals with chronic PTSD, neurofeedback (NF) training significantly reduced PTSD symptoms, with only 27.3% of NF participants still meeting PTSD criteria post-treatment compared to 68.2% in the waitlist group.

The NF training also improved affect regulation capacities, showing effect sizes comparable to established PTSD treatments, indicating its potential as a promising intervention for PTSD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Neurofeedback for Chronic PTSD. van der Kolk, BA., Hodgdon, H., Gapen, M., et al.[2023]

The review of five studies on alpha-theta EEG biofeedback treatment for alcoholism and PTSD raises important questions about the independence of participant samples, their clinical status before treatment, and the specific treatments they received.

By addressing these questions, the authors aim to enhance the understanding of neurofeedback efficacy, allowing for more objective testing of its claims in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regarding the database for the Peniston alpha-theta EEG biofeedback protocol. Graap, K., Freides, D.[2019]

EEG neurofeedback (EEG NF) is a promising non-invasive method that can help modulate brain activity related to anxiety disorders and PTSD, potentially improving symptoms of over-arousal.

While positive effects of EEG NF have been observed, the exact relationship between symptom improvement and neurophysiological changes remains uncertain due to methodological issues in existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. Micoulaud-Franchi, JA., Jeunet, C., Pelissolo, A., et al.[2021]

The combination of trauma psychotherapy and neurofeedback (specifically infra-low-frequency neurofeedback and alpha-theta training) is effective for treating patients with complex post-traumatic stress disorder (C-PTSD), especially for those who continue to experience symptoms like anxiety and sleep disorders despite traditional therapy.

Over 7 years of practical application, this combined treatment approach has shown satisfying results, particularly in calming trauma-related reactions and aiding in the processing of traumatic memories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Infra-Low-Frequency Neurofeedback for PTSD: A Therapist's Perspective. Spreyermann, R.[2022]

In a study involving 13 adult refugees with chronic PTSD, those who received neurofeedback combined with trauma counseling showed significantly reduced symptoms of trauma, anxiety, and depression compared to those who only received trauma counseling.

Neurofeedback therapy was associated with improved cognitive control, as indicated by increased P3 amplitude in brain activity and better performance on cognitive tasks, suggesting it may help remediate cognitive deficits in PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures. Askovic, M., Watters, AJ., Coello, M., et al.[2020]

In a pilot study involving multiply-traumatized individuals with treatment-resistant PTSD, 40 sessions of EEG biofeedback (neurofeedback) significantly reduced PTSD symptoms, with average Davidson Trauma Scale scores dropping from 69.14 to 49.26.

The neurofeedback training also led to improvements in affect regulation, as indicated by a decrease in scores on the Inventory of Altered Self-Capacities-Affect Dysregulation from 23.63 to 17.20, suggesting potential benefits beyond just PTSD symptom reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Neurofeedback for Chronic PTSD. Gapen, M., van der Kolk, BA., Hamlin, E., et al.[2018]

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