Mindfulness-based Neurofeedback for Rumination

(CHARMS Trial)

Overseen By Gladys Pachas, MD

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: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness-based neurofeedback, which provides real-time feedback on brain activity, can reduce repetitive negative thinking in teens at risk of serious mental illness. Researchers aim to determine whether this approach can alter brain activity patterns, particularly in the default mode network, the part of the brain active during rest and self-referential thoughts. Participants will receive either active or sham neurofeedback sessions following mindfulness training. Teens who frequently experience negative thought loops and have an interest in mindfulness may be well-suited for this study. As an unphased trial, it offers a unique opportunity for teens to explore innovative mindfulness techniques that could enhance mental well-being.

Do I have to stop taking my current medications for the trial?

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 is generally safe and well-tolerated. This treatment uses brain feedback during meditation to improve mental health. Participants report few side effects, and it is considered non-invasive, as it doesn't involve entering the body.

In reviews, participants experienced minimal negative reactions, with most finding the experience comfortable and manageable. Although more studies are needed to confirm these findings, current evidence suggests mindfulness-based neurofeedback is a safe option for enhancing mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness-based neurofeedback for rumination because it offers a novel approach to managing persistent, repetitive thoughts that can be difficult to control. Unlike traditional treatments, such as cognitive-behavioral therapy or medication, which often focus on changing thought patterns or altering brain chemistry, this method uses real-time brain activity feedback to help individuals learn to regulate their mental processes. This neurofeedback technique can potentially provide users with a more direct and empowering way to modify their brain function, potentially leading to more effective and lasting relief from rumination.

What evidence suggests that this trial's treatments could be effective for reducing repetitive negative thinking?

Research shows that mindfulness-based neurofeedback (mbNF), which participants in this trial may receive, can help reduce overactivity in the default mode network (DMN) of the brain. Previous studies have found that mbNF lessens repetitive negative thinking, known as rumination, in people with depression. Early trials suggest that this method can improve mental health by altering connections between different parts of the brain. Real-time fMRI neurofeedback, a technique used in mbNF, has effectively lowered DMN activity. These findings indicate that mbNF could be promising for helping at-risk adolescents with repetitive negative thinking. Meanwhile, another group in this trial will receive sham mindfulness-based neurofeedback, serving as a comparator to evaluate the active treatment's effectiveness. ^{2 3 6 7 8}

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?

This trial is for adolescents who often have repetitive negative thoughts and might be at risk for serious mental health issues. They will be compared to healthy control participants. Specific criteria aren't provided, but typically, trials require participants to meet certain age and health conditions.

Inclusion Criteria

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

I am in or past mid-puberty according to Tanner stages.

Additional Inclusion Criteria for At-Risk Adolescents: Recurrent negative thinking, defined as PTQ-C total score >30

Exclusion Criteria

Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, major depressive disorder other than single episode-mild, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorder

Substance use disorder, moderate or severe in past six months

Visual, auditory, or cognitive impairment (IQ<80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a baseline clinical assessment and a brief resting state MRI scan to assess default mode connectivity

1 day

1 visit (in-person)

Mindfulness Training and Neurofeedback

Participants receive a 45-minute mindfulness training followed by two 15-minute sessions of either active or sham mindfulness-based neurofeedback

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in DMN connectivity post-intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-based Neurofeedback
• Sham mindfulness-based neurofeedback

Trial Overview The study is testing if mindfulness-based neurofeedback (mbNF) can change brain connectivity related to negative thinking in at-risk teens. It's a double-blind trial where participants get either real mbNF or a sham version, along with mindfulness training.

How Is the Trial Designed?

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

Participants will: * Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity * Receive a 45-minute mindfulness training * Receive two 15-minute sessions of mindfulness-based neurofeedback

Group II: Healthy Control (HC) Active Control 1 Intervention

Healthy control participants will complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity. They will receive no intervention or comparator.

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

Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611577/

Reducing default mode network connectivity with mindfulness ... We developed mindfulness-based fMRI neurofeedback (mbNF) for adolescents that aims to reduce default mode network (DMN) hyperconnectivity.

2. nature.com nature.com/articles/s41598-022-17325-6

Mindfulness meditation increases default mode, salience, ... One month of mindfulness meditation effectively increases interconnectivity between networks of the triple network model (DMN, SN, CEN).

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

Mindfulness-based real-time fMRI neurofeedback Preliminary results from a recent proof-of-concept trial suggest reduced rumination among depressed adults following real-time neurofeedback ...

4. 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.

5. whitfield-gabrieli.sites.northeastern.edu whitfield-gabrieli.sites.northeastern.edu/files/2022/11/Real-time-fMRI-neurofeedback-reduces-auditory-hallucinations-and-modulates-resting-state-connectivity-of-involved-brain-regions-Part-2-Default-Mode-Network-Preliminary-evidence-.pdf

Real-time-fMRI-neurofeedback-reduces-auditory- ... Results show a reduction of DMN hyperconnectivity and increase in DMN-CEN anticorrelation. Furthermore, the change in individual DMN connectivity significantly ...

6. 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 ...

7. jmir.org jmir.org/2025/1/e68204

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.

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

The Combined Effectiveness of Neurofeedback and ... In this review, we examine two categories of interventions combined with neurofeedback: the first is behavioral/cognitive approaches—including ...