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

Not Applicable

Not yet recruiting

• Conditions: Repetitive Negative Thinking; Neurofeedback

• Registration Number: NCT07055217
• Lead Sponsor: Massachusetts General Hospital

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 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.

Detailed Description

A sample of 50 at-risk adolescents with elevated repetitive negative thinking and 50 matched control participants, ages 13-19, will be enrolled into this double blind, randomized clinical trial. Healthy control participants will be matched for age, sex, parental education, and school. 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-08-01
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Ages 13-19, 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-C total score >30

Exclusion Criteria

• Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, major depressive disorder other than single episode-mild, 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, history of 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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resting State Default Mode Network (DMN) Functional Connectivity	Baseline	We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Change in Within-Person Default Mode Network (DMN) Functional Connectivity	Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)	A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.
Time Effect on Within-DMN Connectivity	Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)	A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).

Trial Locations

Locations (1)

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114; 🇺🇸 Boston, Massachusetts, United States