Image

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

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

Recruiting
13-21 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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)

Study details
    Repetitive Negative Thinking
    Neurofeedback

NCT07055217

Massachusetts General Hospital

31 January 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.