Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

Launched by MASSACHUSETTS GENERAL HOSPITAL · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a technique called mindfulness-based neurofeedback (mbNF) to help reduce negative thinking in teenagers and young adults aged 14 to 21 who may be at risk for serious mental health issues. The goal is to see if this approach can improve their negative thoughts and help them function better socially and in their daily lives compared to a fake version of the treatment. In total, 90 participants will take part in this study, which involves sessions of mindfulness training and practicing mindfulness techniques over three months.

To be eligible for the trial, participants should be between 14 and 21 years old and experience frequent negative thoughts. They must be able to read and write in English and have access to a mobile device for daily surveys. However, those with certain mental health conditions, significant substance use issues, or medical problems that could interfere with the study will not be able to participate. If they join, participants can expect to receive either the active mindfulness training or the sham (fake) treatment in a way that they won't know which one they are receiving. This trial is a great opportunity for young people looking for new ways to manage their thoughts and improve their mental well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ages 14-21, inclusive
• • Recurrent negative thinking, defined as PTQ-C (\<18 years) or PTQ (18 years or older) total score \>30 and at least two questions scored 3 or 4.
• • Able to understand study procedures, read, and write in English
• • If age is 18 years or older: Competent and willing to provide written informed consent
• • If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
• • Access to a mobile device to complete daily survey assessments
• Exclusion Criteria:
• • Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorder
• • Substance use disorder, moderate or severe in past six months.
• • Unstable medical or neurologic condition, epilepsy or seizure disorder, head injury, loss of consciousness \>5 minutes
• • 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 enrollment
• • Individuals who are under the legal protection of the government or state (Wards of the State)
• • Inability to speak, read, or write English fluently