Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

NCT06901232 | Not Yet Recruiting DMC

• 1 other identifier: 2024P003611
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Repetitive Negative Thinking; Serious Mental Illness Symptoms

Keywords

Mindfulness; Repetitive negative thinking; Serious mental illness symptoms

Outcome Measures

Primary Outcomes (1)

• Change in repetitive negative thinking (RNT)

  Perseverative Thinking Questionnaire- Child Version (PTQ-C), is a content-independent measure of RNT, with 15 items, rated on a 5- point scale (never, almost never, sometimes, often, almost always), with excellent internal consistency, Cronbach's alpha=0.95, in both clinical and non-clinical samples, validated and normed in clinical and non-clinical adolescent and young adult samples as a transdiagnostic research tool that has been shown to predict MDD. Higher scores indicate greater RNT.

  2 weeks

Secondary Outcomes (5)

• Change in psychotic symptom severity

  2 weeks

• Change in depressive symptom severity

  2 weeks

• Change in social and occupational functioning

  2 weeks

• Change in worry symptom severity

  2 weeks

• Change in rumination symptom severity

  2 weeks

Study Arms (2)

Active mindfulness-based neurofeedback (Active mbNF)

EXPERIMENTAL

Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of active mindfulness-based neurofeedback

Behavioral: Mindfulness Training; Behavioral: Active mindfulness-based neurofeedback (Active mbNF)

Sham mindfulness-based neurofeedback (Sham mbNF)

SHAM COMPARATOR

Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of sham neurofeedback

Behavioral: Mindfulness Training; Behavioral: Sham mindfulness-based neurofeedback

Interventions

Mindfulness Training 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); Sham mindfulness-based neurofeedback (Sham mbNF)

Active mindfulness-based neurofeedback (Active mbNF) 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.

Active mindfulness-based neurofeedback (Active mbNF)

Sham mindfulness-based neurofeedback 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.

Sham mindfulness-based neurofeedback (Sham mbNF)

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

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

Boston, Massachusetts, 02114, United States

Location

Study Officials

• A. Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Susan Whitfield-Gabrieli, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Jashinski, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founding Director Massachusetts General Hospital Center for Addiction Medicine; Cox Family Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following manuscript publication.

Locations

US (1)