NCT07055217 Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
| NCT ID | NCT07055217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Repetitive Negative Thinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-11-04 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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, 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)
Contact & Investigator
A. Eden Evins, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07055217 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 21 Years, studying Repetitive Negative Thinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07055217 currently recruiting?
Yes, NCT07055217 is actively recruiting participants. Contact the research team at jjashinski@mgh.harvard.edu for enrollment information.
Where is the NCT07055217 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07055217 clinical trial?
NCT07055217 is sponsored by Massachusetts General Hospital. The principal investigator is A. Eden Evins, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 100 participants.