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

NCT ID: NCT07055217

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2027-04-30

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.

Detailed Description

A sample of 50 at-risk adolescents with elevated repetitive negative thinking and 50 matched healthy control participants, ages 13-21, will be enrolled into this double blind, randomized clinical trial. Healthy control participants will be matched for age and sex. All participants will complete a baseline clinical assessment and return within two weeks for a brief resting state MRI scan to assess default mode connectivity (DMN). At Visit 2, at-risk adolescents will then receive a 45-minute mindfulness training by clinically trained staff. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback. Participants and staff will remain blind to assignment. Participants will have fMRI scans for resting state functional connectivity before and after mindfulness practice. Participants will complete two doses (15 minutes per dose) of real or sham mbNF in the scanner. At-risk adolescents will also complete a follow-up clinical assessment at 4-weeks post-scan (Visit 3) and complete daily surveys for approximately four weeks from Visit 2 to Visit 3.

Conditions

Repetitive Negative Thinking; Neurofeedback

Study Design

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

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Mindfulness Training

Intervention Type: BEHAVIORAL

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)

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. 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)

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

Group Type: SHAM_COMPARATOR

Mindfulness Training

Intervention Type: BEHAVIORAL

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.

Sham mindfulness-based neurofeedback (Sham mbNF)

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-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, moderate, severe or recurrent 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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Eden Evins

Cox Family Professor of Psychiatry

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

Site Status: RECRUITING

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

R61MH139856

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P001338

Identifier Type: -

Identifier Source: org_study_id