Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

NCT ID: NCT06901232

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-09-30
• Study Completion Date: 2029-04-30

Brief Summary

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.

Detailed Description

Approximately 90 at-risk adolescents ages 14-21 years old will be enrolled in a double-blind, randomized clinical trial. All participants will undergo a baseline clinical assessment (Visit 1), which will serve as an important baseline for daily symptom fluctuation and use of mindfulness strategies prior to training. Approximately 1-2 weeks after the baseline assessments, all participants will complete an in-person visit (Visit 2) in which they will complete a brief MRI scan (resting state localizer) and a 45-minute mindfulness training. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback (n=45 each group). Randomization will be stratified by information obtained at the baseline assessment: biological sex, prior daily/near daily mindfulness practice for 8 weeks or more. A study staff member with no participant contact will create randomization tables in REDCap to alloacte participants to either active or sham mbNF. Participants and staff will remain blinded to assignment. Participants will then complete another MRI session what will include resting state scans as well as the active or sham mbNF. Approximately 1-2 weeks later, participants will return for another in-person visit (Visit 3) that includes a mindfulness refresher and repeats the procedures of Visit 2. Participants will briefly rate their mindfulness practice daily for three months using a brief, online survey. At 1-, 3- and 12-months post-neurofeedback, participants will complete self-report and clinician-rated assessments to probe repetitive negative thinking and prodromal psychiatric symptoms.

Conditions

Repetitive Negative Thinking; Serious Mental Illness Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active mindfulness-based neurofeedback (Active mbNF)

Participants will:

• Receive a 45-minute mindfulness training
• Receive two sessions of active mindfulness-based neurofeedback

Group Type: EXPERIMENTAL

Mindfulness Training

Intervention Type: BEHAVIORAL

All participants will complete a single 45-minute mindfulness training at Visit 2, with a refresher prior to the second mbNF session at Visit 3. 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.

Active mindfulness-based neurofeedback (Active mbNF)

Intervention Type: BEHAVIORAL

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. Participants will be trained until they feel competent to use mental noting in the scanner. During active mbNF (6 runs, 2.5 minutes each), participants will use mental noting with the aim of controlling 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)

Participants will:

• Receive a 45-minute mindfulness training
• Receive two sessions of sham neurofeedback

Group Type: SHAM_COMPARATOR

Mindfulness Training

Intervention Type: BEHAVIORAL

All participants will complete a single 45-minute mindfulness training at Visit 2, with a refresher prior to the second mbNF session at Visit 3. 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.

Sham mindfulness-based neurofeedback

Intervention Type: BEHAVIORAL

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. Participants will be trained until they feel competent to use mental noting in the scanner. During sham mbNF, participants will view a visual display (white dot, red and blue circles) extracted from a previously acquired mbNF session. The 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 participants across groups are viewing equivalent stimuli for the same amount of overall time.

Interventions

Mindfulness Training

All participants will complete a single 45-minute mindfulness training at Visit 2, with a refresher prior to the second mbNF session at Visit 3. 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.

Intervention Type: BEHAVIORAL

Active mindfulness-based neurofeedback (Active 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. Participants will be trained until they feel competent to use mental noting in the scanner. During active mbNF (6 runs, 2.5 minutes each), participants will use mental noting with the aim of controlling 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.

Intervention Type: BEHAVIORAL

Sham mindfulness-based neurofeedback

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. Participants will be trained until they feel competent to use mental noting in the scanner. During sham mbNF, participants will view a visual display (white dot, red and blue circles) extracted from a previously acquired mbNF session. The 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 participants across groups are viewing equivalent stimuli for the same amount of overall time.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 14-21, inclusive
• Recurrent negative thinking, defined as PTQ-C (<18 years) or PTQ (18 years or older) total score >30 and at least two questions scored 3 or 4.
• Able to understand study procedures, read, and write in English
• If age is 18 years or older: Competent and willing to provide written informed consent
• If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
• Access to a mobile device to complete daily survey assessments

Exclusion Criteria

• 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
• Substance use disorder, moderate or severe in past six months.
• Unstable medical or neurologic condition, epilepsy or seizure disorder, head injury, loss of consciousness >5 minutes
• 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 enrollment
• Individuals who are under the legal protection of the government or state (Wards of the State)
• Inability to speak, read, or write English fluently

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Eden Evins

Founding Director Massachusetts General Hospital Center for Addiction Medicine; Cox Family Professor of Psychiatry, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A. Eden Evins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Susan Whitfield-Gabrieli, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Julia Jashinski, MSW

Role: CONTACT

jjashinski@mgh.harvard.edu

617-643-1984

Facility Contacts

Julia Jashinski, MSW

Role: primary

jjashinski@mgh.harvard.edu

617-643-1984

Other Identifiers

2024P003611

Identifier Type: -

Identifier Source: org_study_id