20 Participants Needed

Neurofeedback Training for Maternal Distress

PI
Overseen ByPrincipal Investigator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Neuroptimal Neurofeedback for maternal distress?

Research shows that neurofeedback, a treatment that helps people learn to control their brain activity, has been effective for various conditions like PTSD and alcohol use disorder. It can improve symptoms like anxiety and depression by enhancing cognitive control, and it generally has no significant side effects.12345

Is neurofeedback generally safe for humans?

The safety of neurofeedback has not been thoroughly investigated, but clinical experience suggests it is reasonably safe.26789

How does neurofeedback training differ from other treatments for maternal distress?

Neurofeedback training is unique because it focuses on helping mothers regulate their brain activity to manage stress and emotional responses, rather than relying on medication or traditional therapy. This approach leverages the brain's ability to adapt and change, potentially offering a non-invasive and personalized way to address maternal distress.1011121314

Eligibility Criteria

This trial is for postpartum mothers within 3-24 months after giving birth, who are experiencing significant PTSD symptoms or dissociation. Participants must be undergoing regular in-person psychotherapy in the Greater Detroit area.

Inclusion Criteria

I show signs of PTSD or its dissociative subtype based on recent screenings.
I gave birth between 3 to 24 months ago.
I am currently seeing a therapist in person in the Greater Detroit area.

Exclusion Criteria

Have ever experienced previous head injury with loss of consciousness
Are currently pregnant
I have a documented history of epilepsy.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Training

Participants undergo a neurofeedback training program to enhance wellness, with pre and post-training assessments

3 months
Weekly sessions

Follow-up

Participants are monitored for changes in trauma symptoms, mental health, and parenting behaviors after the training phase

4 weeks

Treatment Details

Interventions

  • Neuroptimal Neurofeedback
Trial Overview The study tests a Neurofeedback training program (Neuroptimal) to see if it can improve well-being, emotional regulation, reduce trauma-related mental health issues, and positively affect parenting behaviors and infant behavior among trauma-exposed mothers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neurofeedback TrainingExperimental Treatment1 Intervention
Mothers in the Neurofeedback Training group will complete pre and post-training self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in this group will all be receiving in-person psychotherapy outside of the study, and they will all demonstrate clinically significant symptoms aligned with post-traumatic stress disorder and/or it's dissociative subtype.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials
318
Recruited
111,000+

Findings from Research

A pilot study involving 16 specialists showed that using EEG-based neurofeedback to control the loudness of music significantly reduced stress and improved mental and emotional well-being compared to simply listening to music.
The method demonstrated the potential for personalized music therapy, as it tailored the music experience to the individual's EEG signals, leading to more effective stress management.
Stress Coping Via Musical Neurofeedback.Alexander, F.[2022]
Neurofeedback (NF) training has shown promising results in improving attention and memory in both healthy individuals and patients, particularly children with ADHD, who demonstrated behavioral and cognitive improvements after specific training methods.
For drug-resistant epilepsy patients, NF training has led to significant and lasting reductions in seizure frequency and intensity, indicating its potential as a valuable treatment option in neuropsychiatric disorders.
Annotation: neurofeedback - train your brain to train behaviour.Heinrich, H., Gevensleben, H., Strehl, U.[2009]
Neurofeedback therapy, which uses real-time feedback on brainwaves to promote self-regulation, shows promise in treating psychiatric disorders, including alcohol dependence, with the potential for long-term benefits due to neural plasticity.
This therapy has minimal side effects, primarily limited to rare temporary headaches, and can produce therapeutic effects more quickly than traditional psychotherapies.
Neurofeedback therapy for alcohol use disorder.Yamaguchi, T., Tazaki, M.[2019]

References

Stress Coping Via Musical Neurofeedback. [2022]
Annotation: neurofeedback - train your brain to train behaviour. [2009]
Neurofeedback therapy for alcohol use disorder. [2019]
Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures. [2020]
Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]
Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]
Neurofeedback and traumatic brain injury: a literature review. [2022]
Efficacy of neurofeedback as a treatment modality for children in the autistic spectrum. [2022]
19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype? [2020]
No stress please! Mechanisms of stress hyporesponsiveness of the maternal brain. [2021]
11.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The role of dopamine and opioid systems in the regulation of maternal behavior]. [2014]
12.United Statespubmed.ncbi.nlm.nih.gov
The maternal brain and its plasticity in humans. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Postpartum depression: Etiology, treatment and consequences for maternal care. [2022]
Neurobiology of peripartum mental illness. [2023]
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