Actively Recruiting
Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
Led by Massachusetts General Hospital · Updated on 2026-05-19
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adolescents aged 13 to 21 who experience repetitive negative thinking and are considered at risk for serious mental illness. The study aims to compare brain connectivity patterns, specifically in the default mode network (DMN), between at-risk adolescents and healthy peers. It also evaluates whether a longer session of mindfulness-based neurofeedback can reduce DMN connectivity more effectively. This is a double-blind, randomized clinical trial involving 50 at-risk adolescents and 50 matched healthy controls. The study includes a 45-minute mindfulness training for at-risk participants, focusing on a technique called mental noting to help manage distress. After training, participants receive either active mindfulness-based neurofeedback or a sham version during MRI scans. Both at-risk and healthy control participants undergo resting state MRI scans to assess DMN connectivity, with at-risk adolescents receiving two 15-minute neurofeedback sessions. Healthy controls do not receive any intervention. Participants attend multiple visits, including baseline clinical assessments and MRI scans to measure brain connectivity before and after mindfulness practice. At-risk adolescents complete daily surveys for about four weeks and have a follow-up clinical assessment one month after their scan. The study measures changes in DMN connectivity at several time points to evaluate the effects of the neurofeedback intervention, ensuring careful monitoring and data collection throughout the trial period.
CONDITIONS
Brief Title
Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 13-21, inclusive
- If under 18 years old: able and willing to provide written informed assent, with a parent or legal guardian providing written informed consent
- If 18 years or older: able and willing to provide written informed consent
- Tanner puberty stage 3 or higher
- Able to understand study procedures and read/write in English
- Access to a mobile device for daily surveys
- At-risk adolescents must have recurrent negative thinking with PTQ score over 30 and at least two items rated 3 or 4
- Healthy controls must have PTQ score below 15 with no items rated 3 or 4
You will not qualify if you...
- History of psychotic disorders, bipolar disorder, moderate or severe major depressive disorder, conduct disorder, developmental disorders, PTSD, or OCD
- Severe lifetime substance use disorder
- Unstable medical or neurological conditions such as epilepsy, seizure disorder, head injury with loss of consciousness over 5 minutes
- MRI contraindications including ferromagnetic implants, pacemakers, metallic particles, vascular clips, prior neurosurgery, prosthetic heart valves, magnetic dental implants, or claustrophobia
- Visual, auditory, or cognitive impairment with IQ below 80
- Any condition likely to prevent safe adherence to the protocol
- Pregnancy; negative pregnancy test required for those of childbearing potential
- Individuals under legal protection of government or state (wards of the state)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Within 2 weeks after screening
Participants complete a baseline clinical assessment and a resting state MRI scan to assess default mode connectivity (DMN).
1 visit (in-person)
Duration - Single day visit
At-risk adolescents receive a 45-minute mindfulness training by clinically trained staff, followed by randomization to either active or sham mindfulness-based neurofeedback. Participants complete two 15-minute sessions of real or sham neurofeedback in the MRI scanner with fMRI scans before and after mindfulness practice.
1 visit (in-person) including mindfulness training, MRI scans, and neurofeedback sessions
Duration - Approximately 4 weeks
Participants complete daily surveys to monitor their experiences and progress.
Daily surveys completed remotely
Duration - 1 day
Participants complete a follow-up clinical assessment to evaluate outcomes approximately 4 weeks after treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Julia Jashinski, MSW
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here