Neurofeedback for Traumatic Stress Disorders in New Mothers

Overseen By Lisa S Panisch, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wayne State University

Must not be taking: Benzodiazepines, Narcotics, Cannabis

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Mobile Neurofeedback Intervention, Neurofeedback Therapy, EEG Biofeedback, Brain-Computer Interface Training for traumatic stress disorders in new mothers?

Research shows that neurofeedback, a type of brain training, can help reduce symptoms of PTSD (post-traumatic stress disorder) and improve emotional regulation. Studies have found it effective in reducing PTSD symptoms and calming trauma-related reactions, suggesting it could be beneficial for new mothers experiencing traumatic stress. ^{1 2 3 4 5}

Is neurofeedback generally safe for humans?

Neurofeedback, also known as EEG biofeedback, has been used for over 30 years and studies suggest it is generally safe for humans, with research showing its use in conditions like PTSD and anxiety disorders without significant safety concerns. ^{1 2 3 4 6}

How does the Mobile Neurofeedback Intervention treatment differ from other treatments for traumatic stress disorders in new mothers?

Mobile Neurofeedback Intervention is unique because it uses brainwave monitoring to help individuals gain control over their brain activity, potentially improving cognitive control and reducing symptoms of trauma, anxiety, and depression. Unlike traditional therapies, it offers a brain-based approach that can be combined with other treatments to enhance their effectiveness. ^{1 3 4 5 6}

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Mobile Neurofeedback Intervention (Behavioural 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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Regarding the database for the Peniston alpha-theta EEG biofeedback protocol. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Neurofeedback for Chronic PTSD. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

A Pilot Study of Neurofeedback for Chronic PTSD. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures. [2020]