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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness-based neurofeedback, which combines mindfulness training with real-time brain activity feedback, can reduce repetitive negative thinking and improve social functioning in adolescents. Participants will receive either active mindfulness-based neurofeedback or a sham version, which serves as a placebo-like treatment, to compare outcomes. The trial targets teens and young adults aged 14-21 who frequently experience negative thoughts. Participants should not have certain mental health disorders, such as anxiety or bipolar disorder, and must have access to a mobile device for daily surveys. As an unphased trial, this study allows participants to contribute to groundbreaking mental health research and potentially benefit from innovative treatment strategies.

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 prior data suggests that mindfulness-based neurofeedback is safe for adolescents?

Research has shown that mindfulness-based neurofeedback (mbNF) is generally safe and well-tolerated. Studies have found that this treatment can help people relax and reduce anxiety. Importantly, there are no major reports of harmful side effects from using mbNF.

One study found that combining neurofeedback with mindfulness or cognitive behavioral therapy improved mental health without causing significant problems. This suggests that people usually handle the treatment well.

While researchers continue to study all the effects of mbNF, current evidence supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness-based neurofeedback because it offers a unique approach to improving mental health disorders by combining mindfulness practices with real-time brain feedback. Unlike medications or traditional talk therapy, this treatment allows participants to see their brain activity and learn how to regulate it, potentially leading to more effective and personalized mental health care. This technique could help individuals gain better control over their thoughts and emotions, leading to faster and more sustainable improvements in mental health.

What evidence suggests that mindfulness-based neurofeedback is effective for mental health disorders?

This trial will compare active mindfulness-based neurofeedback (Active mbNF) with a sham version (Sham mbNF). Research has shown that mindfulness-based neurofeedback (mbNF) can improve mental health. One study found that combining neurofeedback with mindfulness reduced depression, anxiety, and stress. Another program reported significant stress reduction and better overall mental health. mbNF helps balance brain activity, potentially improving self-control and reducing negative thoughts. Overall, early evidence suggests mbNF could benefit people at risk of serious mental health issues. ^{3 4 5 6 7}

Who Is on the Research Team?

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Susan Whitfield-Gabrieli, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11419071/

Mindfulness-based Neurofeedback: A Systematic Review of ... Neurofeedback concurrent with mindfulness meditation may reveal meditation effects on the brain and facilitate improved mental health outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025004356

The Combined Effectiveness of Neurofeedback and ... NFB combined with CBT or mindfulness showed preliminary improvements in depression, anxiety, and stress (p<.05–.001). Music adjuncts showed no ...

3. mhealth.jmir.org mhealth.jmir.org/2023/1/e42851

The Effectiveness of a Neurofeedback-Assisted Mindfulness ... Results: The 4-week program showed significant stress reduction (Wald χ22=107.167, P<.001) and improvements in psychological indices including ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05223-8

Mindfulness-based real-time fMRI neurofeedback This study aims to establish mindfulness-based real-time fMRI neurofeedback (mbNF) as a non-invasive approach to downregulate the default mode network (DMN)

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1410932/full

Study protocol of a proposed Neurofeedback-Assisted ... Neurofeedback-Assisted Mindfulness Training Programs may prove beneficials for improving self-control abilities, a key ability in addressing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046271/

Consumer-Grade Neurofeedback With Mindfulness ... This study aimed to systematically review and meta-analyze the impacts of consumer-grade mindfulness-based neurofeedback compared with control conditions.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07055217

Study Details | NCT07055217 | Effect of Mindfulness-based ... This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show ...