Actively Recruiting

Phase Not Applicable
Age: 13Years - 21Years
All Genders
Healthy Volunteers
NCT07055217

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

Led by Massachusetts General Hospital · Updated on 2026-02-12

100

Participants Needed

1

Research Sites

73 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years - 21Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 13-21, inclusive
  • If under 18 years old: able and willing to provide written assent and have a parent or legal guardian willing to provide written 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 and write in English
  • Access to a mobile device to complete daily surveys
  • For at-risk adolescents: recurrent negative thinking with PTQ/PTQ-C total score greater than 30 and at least two items rated 3 (Often) or 4 (Almost Always)
  • For healthy controls: PTQ/PTQ-C total score less than 15 with no items rated 3 or 4
Not Eligible

You will not qualify if you...

  • Lifetime diagnosis of 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 neurological condition, history of epilepsy or seizure disorder, head injury, or loss of consciousness over 5 minutes
  • MRI contraindications such as ferromagnetic implants, pacemaker, metallic particles, vascular clips, previous neurosurgery, prosthetic heart valves, magnetic dental implants, or claustrophobia
  • Visual, auditory, or cognitive impairment (IQ below 80) that may interfere with participation
  • Any condition making adherence to the study unsafe or unlikely as judged by the investigator
  • Pregnancy (negative pregnancy test required for individuals of childbearing potential at enrollment)
  • 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

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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

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Research Team

J

Julia Jashinski, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking | DecenTrialz