Mindfulness-based Neurofeedback for Adolescent Repetitive Negative Thinking

This study is looking at how mindfulness-based neurofeedback (Real mbNF) might help adolescents (ages 13-21) who experience a lot of repetitive negative thinking. This type of thinking can put young people at risk for serious mental health issues. The study will compare Real mbNF with a sham (inactive) version of the neurofeedback (Sham mbNF) after a mindfulness training session. Researchers want to see if Real mbNF can change brain activity in a specific network called the Default Mode Network (DMN), which is involved in self-reflection and mind-wandering. They hope to see a reduction in DMN connectivity. The study plans to enroll 100 participants, but its current status is unclear.

Study design
This is a double-blind, randomized clinical trial involving 100 participants. It compares active mindfulness-based neurofeedback with a sham version.
What's involved
You would have a baseline assessment, an MRI scan, a 45-minute mindfulness training, and then two 15-minute sessions of either real or sham neurofeedback in an MRI scanner. At-risk adolescents will also complete a follow-up assessment and daily surveys for about four weeks.
Compensation
Not stated in the trial record.
Follow-up
At-risk adolescents will have a follow-up clinical assessment at 4-weeks post-scan and complete daily surveys for approximately four weeks.

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NCT07055217

Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking

Recruiting
NAAges 13–21InterventionalPrevention
Massachusetts General Hospital
~100 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Mindfulness TrainingMindfulness-based Neurofeedback (Real mbNF)Sham mindfulness-based neurofeedback (Sham mbNF)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resting State Default Mode Network (DMN) Functional Connectivity
Measured over Baseline
+2 more outcomes measured
Repetitive Negative Thinking
Neurofeedback
1 sites across 1 states
Massachusetts1
  • A. Eden Evins, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • Susan Whitfield-Gabrieli, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

Ages 13-21, inclusive
If \<18 years old: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
If age ≥18 years: Competent and willing to provide written informed consent
Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
Able to understand study procedures, read, and write in English
Access to a mobile device to complete daily surveys
PTQ/PTQ-C total score \<15, with zero items rated as 3 (Often) or 4 (Always)

Exclusion

Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major depressive disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or obsessive compulsive disorder
Severe lifetime substance use disorder
Unstable medical or neurologic condition as determined by study staff, history of epilepsy or seizure disorder, head injury, loss of consciousness \>5 minutes by participant self-report
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).
Visual, auditory, or cognitive impairment (IQ\<80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to participate.
Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
Pregnancy: a negative pregnancy test is required at the time of enrollment for any individuals of childbearing potential
Individuals who are under the legal protection of the government or state (Wards of the State)
  • Resting State Default Mode Network (DMN) Functional ConnectivityBaseline

    We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).

  • Change in Within-Person Default Mode Network (DMN) Functional ConnectivityPre-mbNF, Post-mbNF (30 minutes after pre-mbNF)

    A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.

  • Time Effect on Within-DMN ConnectivityPre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)

    A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).