Mindfulness-based Neurofeedback for Mental Health Disorders

(CHARMS Trial)

Overseen By Julia Jashinski, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychotic, Anxiety, Bipolar, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2-4 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will test the hypothesis that mindfulness-based neurofeedback (mbNF) will improve repetitive negative thinking and social and role functioning over sham neurofeedback in adolescents at risk for serious mental illness. To do so, 90 adolescents ages 14-21 with elevated repetitive negative thinking will be enrolled into a double-blind randomized clinical trial of sessions of mindfulness training with either active mindfulness-based neurofeedback or sham neurofeedback and three months of mindfulness practice and follow up.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Mindfulness-based Neurofeedback for mental health disorders?

Research shows that neurofeedback, which helps people learn to control their brain activity, has been effective for various brain-related issues and can work quickly with few side effects. Mindfulness practices, which help people focus on the present moment, have also been shown to improve mental health in different psychiatric conditions. ^{1 2 3 4 5}

Is mindfulness-based neurofeedback safe for humans?

Neurofeedback, a noninvasive treatment that involves monitoring and responding to brain activity, has been used for various mental health issues and is generally considered safe, especially for those who cannot tolerate medication or traditional therapy. However, its use in routine clinical practice is still limited, and more controlled studies are needed to fully understand its safety profile. ^{1 6 7 8 9}

How is Mindfulness-based Neurofeedback different from other treatments for mental health disorders?

Mindfulness-based Neurofeedback is unique because it combines mindfulness meditation, which helps individuals focus on the present moment, with neurofeedback, a technique that trains people to regulate their brain activity. This approach is noninvasive and can be particularly useful for those who do not respond well to medication or traditional therapies like cognitive behavioral therapy. ^{1 2 4 10 11}

Research Team

Susan Whitfield-Gabrieli, PhD

Principal Investigator

Massachusetts General Hospital

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adolescents aged 14-21 who often have repetitive negative thoughts and are at risk for serious mental illness can join this study. They must be willing to undergo mindfulness training with neurofeedback sessions and continue practicing mindfulness for three months.

Inclusion Criteria

Able to understand study procedures, read, and write in English

Access to a mobile device to complete daily survey assessments

I am between 14 and 21 years old.

Exclusion Criteria

Substance use disorder, moderate or severe in past six months

Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorder

MRI contraindications (i.e. presence of ferromagnetic implants, cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, magnetic dental implants claustrophobia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a baseline clinical assessment to establish symptom fluctuation and mindfulness strategy use

1 day

1 visit (in-person)

Treatment

Participants receive mindfulness training and either active or sham neurofeedback, including MRI sessions

2-4 weeks

2 visits (in-person)

Mindfulness Practice

Participants practice mindfulness daily and complete online surveys for three months

12 weeks

Follow-up

Participants are monitored for changes in repetitive negative thinking and psychiatric symptoms at 1-, 3-, and 12-months post-neurofeedback

12 months

3 visits (in-person)

Treatment Details

Interventions

• Mindfulness-based Neurofeedback

Trial Overview The trial is testing if a special kind of brain training called active mindfulness-based neurofeedback (mbNF) helps reduce negative thinking better than fake (sham) neurofeedback in teens at risk for severe mental health issues.

Participant Groups

Group I: Active mindfulness-based neurofeedback (Active mbNF) Experimental Treatment 2 Interventions

Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of active mindfulness-based neurofeedback

Group II: Sham mindfulness-based neurofeedback (Sham mbNF) Placebo Group 2 Interventions

Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of sham neurofeedback

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

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]

Mindfulness Based Interventions (MBIs) have gained significant traction in recent years for their effectiveness in treating various psychiatric disorders, highlighting their growing importance in mental health care.

Research supports that MBIs work through cognitive, psychological, and neural mechanisms, making them a valuable addition to traditional treatment methods for improving mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions in Psychiatry. Shapero, BG., Greenberg, J., Pedrelli, P., et al.[2023]

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

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]

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]

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 is gaining recognition in scientific and medical communities, indicating its potential relevance in treatment and research.

Researchers have developed a consensus checklist to enhance the quality of reporting and experimental design in neurofeedback studies, which could lead to more reliable and effective applications of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). Ros, T., Enriquez-Geppert, S., Zotev, V., et al.[2022]

References

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

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]

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

Mindfulness-Based Interventions in Psychiatry. [2023]

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

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Annotation: neurofeedback - train your brain to train behaviour. [2009]

5. Japan pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Neurofeedback: One of today's techniques in psychiatry? [2017]

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

Neurofeedback and traumatic brain injury: a literature review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Attentional and affective consequences of technology supported mindfulness training: a randomised, active control, efficacy trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Closed-loop brain training: the science of neurofeedback. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Documenting the Impact of Infra Low Frequency Neurofeedback on Underserved Populations With Complex Clinical Presentations. [2022]