Recruiting

Mindfulness with Neurofeedback

Sponsor:

Massachusetts General Hospital

Code:

NCT07055217

Conditions

Repetitive Negative Thinking

Neurofeedback

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Accepted

Interventions

Mindfulness Training

Mindfulness-based Neurofeedback (Real mbNF)

Sham mindfulness-based neurofeedback (Sham mbNF)

Study Details

Brief summary:

This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer session of mindfulness based neurofeedback will lead to greater reduction in DMN connectivity. To do so, 50 adolescents with elevated repetitive negative thinking and 50 matched healthy control participants will be enrolled into a double-blind randomized clinical trial of a session of mindfulness training with either active mindfulness-basde neurofeedback or sham mindfulness-based neurofeedback.

Conditions

Repetitive Negative Thinking

Neurofeedback

Study ID

NCT07055217

Start date

Nov 4, 2025

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 21

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Additional Inclusion Criteria for At-Risk Adolescents - Recurrent negative thinking, defined as PTQ/PTQ-C total score >30 with at least two items rated as 3 (Often) or 4 (Almost Always)

Additional Inclusion Criteria for Healthy Controls

-PTQ/PTQ-C total score <15, with zero items rated as 3 (Often) or 4 (Always)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Healthy Control (HC)

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.

experimental: Mindfulness-based neurofeedback (mbNF)

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

sham comparator: Sham mindfulness-based neurofeedback (Sham mbNF)

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

Interventions

Mindfulness Training

A single 45-minute mindfulness training will be provided to all at-risk participants at visit 2. Clinically trained study staff will conduct the training with the aim of teaching "mental noting," a core mindfulness technique to be practiced and employed during neurofeedback. Mental noting is a major component of Vipassana (insight mindfulness meditation); its key principles include: "concentration", "observing sensory experience,'' "not 'efforting'", and "contentment".Specifically, participants will be taught to mentally label/note whatever sensation is most prominent in their sensory experience from moment to moment (e.g., seeing, hearing, feeling, thinking). Training will be personalized to identify scenarios in which mental noting can be applied in the context of each person's daily life, explaining the goal of using these strategies to manage distress in daily life.

Mindfulness-based Neurofeedback (Real mbNF)

Before the MRI scan, participants will practice mental noting by verbalizing their mental label, with the study clinician providing feedback. Participants will then complete a silent practice of mental noting while viewing simulated neurofeedback. All participants will be trained until they feel competent to use mental noting in the scanner. Study clinicians will show 85% fidelity on the mindfulness training assessment before working with participants and sessions will be recorded and 10% of sessions will be assessed quarterly for fidelity. During active mbNF (6 runs, 2.5 mins each), participants will use mental noting with the aim of controlling the visual feedback; specifically, they will attempt to move the position of the white dot toward the (upper) red circle and away from the (lower) blue circle.

Sham mindfulness-based neurofeedback (Sham mbNF)

During sham mbNF condition, participants will undergo similar MRI scan procedures. The primary difference in scan procedures is that rather than receiving mbNF, participants will view a visual display (i.e., white dot, red and blue circles) extracted from a previously acquired mbNF session. Thus, the visual display will be independent from brain activity in the sham condition and will simply mirror the stimuli observed by those in the mbNF group. This ensures that participants across groups are viewing equivalent stimuli for the same amount of overall time.

Primary outcome measure

  • Resting State Default Mode Network (DMN) Functional Connectivity [ Time Frame: Baseline ]
  • Change in Within-Person Default Mode Network (DMN) Functional Connectivity [ Time Frame: Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF) ]
  • Time Effect on Within-DMN Connectivity [ Time Frame: Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF) ]

Central Contacts and Locations

Central contacts

Julia Jashinski, MSW

617-643-1984jjashinski@mgh.harvard.edu

Locations

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Julia Jashinski, MSW

617-643-1984jjashinski@mgh.harvard.edu

Principal Investigator:

A. Eden Evins, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Adolescents at risk for serious mental illness
  • Mindfulness
  • Real-time fMRI
  • Neurofeedback
  • DMN Connectivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-19.