Mindfulness-based neurofeedback for teens with high repetitive negative thinking
Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
This study will see if real-time fMRI mindfulness-based neurofeedback helps adolescents with high repetitive negative thinking reduce brain network activity linked to rumination compared with a sham procedure and healthy peers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07055217 on ClinicalTrials.gov |
What this trial studies
Fifty adolescents with elevated repetitive negative thinking and fifty age- and sex-matched healthy controls (ages 13–21) will be enrolled in a double-blind randomized trial. At-risk participants receive a 45-minute mindfulness training and are then randomized to either active or sham real-time fMRI mindfulness-based neurofeedback, delivered as two 15-minute doses during scanning, while both participants and staff remain blind to assignment. All participants undergo baseline clinical assessment and resting-state fMRI before and after the mindfulness practice, and at-risk adolescents complete daily surveys for about four weeks plus a 4-week follow-up assessment. The main measurements are changes in default mode network (DMN) connectivity and clinical measures of repetitive negative thinking.
Who should consider this trial
Good fit: Adolescents aged 13–21 with elevated repetitive negative thinking (PTQ/PTQ-C total score >30 with at least two items rated Often/Almost Always), Tanner stage ≥3, English proficient, and able to use a mobile device for daily surveys are ideal candidates.
Not a fit: Patients with lifetime psychotic or bipolar disorders, moderate/severe or recurrent major depression, those who do not meet the specific PTQ score criteria, are younger than 13, or cannot attend the Boston site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could reduce repetitive negative thinking and normalize DMN connectivity in adolescents, offering a non-drug option to target rumination.
How similar studies have performed: Small adult and pilot studies of real-time fMRI neurofeedback and related mindfulness-based approaches have shown promising changes in DMN connectivity and rumination, but large randomized trials in adolescents are still limited.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114 — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: A. Eden Evins, MD, MPH — Massachusetts General Hospital
- Study coordinator: Julia Jashinski, MSW
- Email: jjashinski@mgh.harvard.edu
- Phone: 617-643-1984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.