Neurofeedback Training for Maternal Distress

Overseen By Principal Investigator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Benzodiazepines, Narcotics, Cannabis

Disqualifiers: Pregnancy, Untreated mental illness, Epilepsy, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Neuroptimal Neurofeedback, a type of brain training, can improve well-being for new mothers dealing with stress and trauma from past experiences. The researchers aim to determine if improved well-being leads to positive changes in emotional control, trauma-related mental health, parenting, and infant behavior such as crying and fussing. The trial seeks postpartum mothers with noticeable symptoms of post-traumatic stress who are already seeing a therapist in the Greater Detroit area. As an unphased trial, participants contribute to innovative research that may enhance support for new mothers.

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 prior data suggests that this neurofeedback training is safe for postpartum mothers?

Research has shown that combining neurofeedback, such as NeurOptimal Neurofeedback, with mindfulness and breathwork can be a safe and non-invasive treatment option. Although specific data on NeurOptimal is lacking, studies on similar neurofeedback methods indicate they are generally well-tolerated with few side effects.

Neurofeedback trains the brain through real-time feedback, potentially improving mental health. So far, studies on neurofeedback treatments have not reported any major negative effects, suggesting it is safe and could be a promising option for those facing postpartum mental health issues.

In this trial, participants receive additional therapy outside of the study to ensure full support. Consulting with a healthcare provider before joining a trial is essential to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neuroptimal Neurofeedback is unique because it offers a non-invasive way to address maternal distress, particularly in those experiencing post-traumatic stress disorder symptoms. Unlike traditional treatments such as medication or talk therapy, which can take time to show results, neurofeedback provides immediate feedback to the brain, potentially leading to quicker improvements in mental health and parenting attitudes. Researchers are excited about this approach because it empowers mothers to regulate their own brain activity, potentially reducing trauma symptoms and enhancing emotional well-being without relying solely on external interventions.

What evidence suggests that Neuroptimal Neurofeedback is effective for maternal distress?

Research has shown that Neuroptimal Neurofeedback, which participants in this trial will receive, can effectively improve mental health issues like anxiety and depression. This technique helps individuals manage their brain activity by providing real-time feedback. Surveys indicate that those who completed 20 or more sessions noticed significant improvements. For new mothers, neurofeedback may aid in achieving emotional balance and reducing trauma-related symptoms. These benefits could also positively impact parenting and the well-being of their babies. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 gave birth between 3 to 24 months ago.

I show signs of PTSD or its dissociative subtype based on recent screenings.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Neurofeedback Training Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Published Research Related to This Trial

Neurobiological changes in new mothers, as shown by fMRI studies, are crucial for forming and maintaining healthy mother-infant relationships, highlighting the brain's adaptability during this period.

Factors such as birth methods, feeding practices, and hormonal changes can influence how a mother's brain adapts, while conditions like postpartum depression can lead to abnormal brain changes that may negatively affect these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The maternal brain and its plasticity in humans. Kim, P., Strathearn, L., Swain, JE.[2023]

Neurofeedback (NF) has been explored as a treatment for various child psychiatric disorders, including ADHD, autism, learning disorders, and epilepsy, by providing real-time feedback on brain activity.

However, many studies on NF have methodological limitations, such as not using proper blinding or sham controls, and while clinical experience suggests NF is reasonably safe, its safety has not been rigorously studied in youth or adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. Hurt, E., Arnold, LE., Lofthouse, N.[2019]

At least 1 in 7 pregnant or recently postpartum women experience mental illnesses, which can negatively impact the health of both the mother and child, highlighting the need for better understanding and treatment.

Research indicates that maternal mental illness is associated with unique neural changes, particularly in the hypothalamus, which may disrupt maternal caregiving behaviors and mother-infant interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurobiology of peripartum mental illness. Pawluski, JL., Swain, JE., Lonstein, JS.[2023]

The maternal brain undergoes significant hormonal and neurobiological changes around birth, leading to reduced stress responses and anxiety, which are crucial for maternal care and offspring survival.

These adaptations are linked to increased inhibitory brain activity (like oxytocin and prolactin) and decreased excitatory pathways, highlighting their importance for both maternal mental health and the healthy development of the baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No stress please! Mechanisms of stress hyporesponsiveness of the maternal brain. Slattery, DA., Neumann, ID.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Annotation: neurofeedback - train your brain to train behaviour. Heinrich, H., Gevensleben, H., Strehl, U.[2009]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Coping Via Musical Neurofeedback. Alexander, F.[2022]

The review highlights the neuroanatomical and hormonal systems, particularly opioid and dopaminergic pathways, that regulate maternal behavior, suggesting a complex interplay of brain chemistry in parenting.

It also discusses the potential for pharmacological interventions to address maternal depression, indicating that understanding these biological mechanisms could lead to effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of dopamine and opioid systems in the regulation of maternal behavior]. Dobriakova, IuV., Tanaeva, KK., Dubynin, VA., et al.[2014]

Pregnancy and the postpartum period significantly increase the risk of developing depressive symptoms in women, affecting about 10-15% of new mothers, which can lead to impaired mother-infant interactions critical for child development.

Postpartum depression can disrupt maternal behaviors such as attachment and sensitivity, potentially resulting in adverse outcomes for children, highlighting the importance of interventions during and after pregnancy to improve maternal mental health and parenting practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression: Etiology, treatment and consequences for maternal care. Brummelte, S., Galea, LA.[2022]

Neurofeedback has shown positive effects in improving symptoms related to traumatic brain injury across 22 studies, indicating its potential as a treatment option.

Despite the promising results, the lack of placebo-controlled studies and standardized methodologies means that further rigorous research is needed to confirm its efficacy and establish clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and traumatic brain injury: a literature review. May, G., Benson, R., Balon, R., et al.[2022]

Neurofeedback therapy successfully reduced the high theta/beta ratio in 42 autistic children, leading to improved cognitive functions after treatment.

The therapy not only enhanced cognitive abilities but also resulted in auxiliary improvements in social skills, thought processes, and attention, suggesting a potential method for addressing cognitive impairments in autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of neurofeedback as a treatment modality for children in the autistic spectrum. Mekkawy, L.[2022]

A review of 15 studies on advanced neurofeedback techniques, including 19-channel Z-score neurofeedback, found no empirical evidence supporting their effectiveness or superiority over standard neurofeedback methods for treating conditions like ADHD and epilepsy.

While some evidence suggests that 3-D LORETA neurofeedback may show efficacy for ADHD and tinnitus distress, the overall quality of studies is low, and further research is needed to confirm these findings and establish any superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype? Coben, R., Hammond, DC., Arns, M.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. Yamaguchi, T., Tazaki, M.[2019]

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]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333415/

Associations between maternal psychological distress and ... Maternal psychological distress and mother-infant bonding problems each predict poorer offspring outcomes. They are also related to each other.

2. digitalcommons.liberty.edu digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=8519&context=doctoral

The Efficacy of Mindfulness, Breathwork, and Neurofeedback ... shown consistent effectiveness in improving mental health outcomes, including anxiety, depression, and chronic pain (Khoury et al., 2013) ...

3. divergenceneuro.com divergenceneuro.com/supporting-postpartum-mental-health-with-neurofeedback/

Supporting Postpartum Mental Health with Neurofeedback Neurofeedback is a non-invasive form of biofeedback that helps individuals learn to regulate their brain activity using real-time EEG data.

4. adnf.org adnf.org/pdf/NeurOptimal%20survey%20en%20anglais.pdf

SURVEY We can also say. (for example) that 25% of trainers reported a 71-80% improvement in performance in clients who completed. 20 or more sessions. The complete set ...

5. sojourncounselling.com sojourncounselling.com/blog/1183775-motherhood-and-mental-health-navigating-postpartum-challenges

Motherhood and Mental Health: Navigating Postpartum ... Explore postpartum psychological issues like blues, depression, anxiety, and psychosis. Learn about symptoms, risk factors, and treatment options.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491613/

Perinatal mental health: a review of progress and challenges A recent systematic review found two small treatment trials of couple interventions which were associated with improvements in maternal depressive symptoms 167 ...

7. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07286-9

Effect of technology-supported mindfulness-based ... This study indicated that technology-supported MBI was effective for better mental health of pregnant and postpartum women. This study ...