Mindfulness-based neurofeedback for teens with high repetitive negative thinking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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, recurrent moderate or severe 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emotion regulation in people who experience repetitive negative thinking

  This project will use harmless infrared brain imaging to see if people who habitually ruminate show different brain responses during emotion-regulation tasks compared with matched healthy adults.

  Recruiting University Hospital, Ghent · Ghent · NCT07513766

• Train the medial prefrontal cortex using imagined social support and real-time neurofeedback

  This trial will test whether real-time fMRI neurofeedback that uses imagined social support helps healthy adults learn to control activity in the medial prefrontal cortex and reduce negative anticipation.

  Recruiting University of Electronic Science and Technology of China · Chengdu, Sichuan · NCT07364084

• Using brain feedback to improve emotion regulation

  This study is testing if brain feedback training can help healthy people manage their negative emotions better.

  Recruiting University of Electronic Science and Technology of China · Hong Kong · NCT06866028

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.