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

Mass General Brigham

Status: Enrolling

Conditions: Neurofeedback; Repetitive Negative Thinking

Treatments: Behavioral: Mindfulness-based Neurofeedback (Real mbNF); Behavioral: Sham mindfulness-based neurofeedback (Sham mbNF); Behavioral: Mindfulness Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07055217

2025P001338

R61MH139856 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. Total participation time is approximately two weeks.

Enrollment: 100 estimated patients

Sex: All

Ages: 13 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

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, 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups

Healthy Control (HC)

No Intervention group

Description:

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.

Mindfulness-based neurofeedback (mbNF)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness Training

Behavioral: Mindfulness-based Neurofeedback (Real mbNF)

Sham mindfulness-based neurofeedback (Sham mbNF)

Sham Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness Training

Behavioral: Sham mindfulness-based neurofeedback (Sham mbNF)