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

Conditions

• Neurofeedback
• Repetitive Negative Thinking

Eligibility Criteria

Sex

ALL

Age

13 Years - 21 Years

Healthy Volunteers

Accepted

Interventions

• Mindfulness Training — BEHAVIORAL
  A single 45-minute mindfulness training will be provided to all at-risk participants at visit 2. Clinically trained study staff will conduct the training with the aim of teaching "mental noting," a core mindfulness technique to be practiced and employed during neurofeedback. Mental noting is a major component of Vipassana (insight mindfulness meditation); its key principles include: "concentration", "observing sensory experience,'' "not 'efforting'", and "contentment".Specifically, participants will be taught to mentally label/note whatever sensation is most prominent in their sensory experience from moment to moment (e.g., seeing, hearing, feeling, thinking). Training will be personalized to identify scenarios in which mental noting can be applied in the context of each person's daily life, explaining the goal of using these strategies to manage distress in daily life.
• Mindfulness-based Neurofeedback (Real mbNF) — BEHAVIORAL
  Before the MRI scan, participants will practice mental noting by verbalizing their mental label, with the study clinician providing feedback. Participants will then complete a silent practice of mental noting while viewing simulated neurofeedback. All participants will be trained until they feel competent to use mental noting in the scanner. Study clinicians will show 85% fidelity on the mindfulness training assessment before working with participants and sessions will be recorded and 10% of sessions will be assessed quarterly for fidelity. During active mbNF (6 runs, 2.5 mins each), participants will use mental noting with the aim of controlling the visual feedback; specifically, they will attempt to move the position of the white dot toward the (upper) red circle and away from the (lower) blue circle.
• Sham mindfulness-based neurofeedback (Sham mbNF) — BEHAVIORAL
  During sham mbNF condition, participants will undergo similar MRI scan procedures. The primary difference in scan procedures is that rather than receiving mbNF, participants will view a visual display (i.e., white dot, red and blue circles) extracted from a previously acquired mbNF session. Thus, the visual display will be independent from brain activity in the sham condition and will simply mirror the stimuli observed by those in the mbNF group. This ensures that participants across groups are viewing equivalent stimuli for the same amount of overall time.

Study Details

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.

Key Dates

Start date

Nov 4, 2025

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: Healthy Control (HC)
  Healthy control participants will complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity. They will receive no intervention or comparator.
• Experimental: Mindfulness-based neurofeedback (mbNF)
  Participants will: * Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity * Receive a 45-minute mindfulness training * Receive two 15-minute sessions of mindfulness-based neurofeedback
• Sham Comparator: Sham mindfulness-based neurofeedback (Sham mbNF)
  Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback

Primary Outcome Measure

Resting State Default Mode Network (DMN) Functional Connectivity [ Time Frame: Baseline ]

Central Contacts

• Julia Jashinski, MSW
  617-643-1984
  [email protected]

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
  Not Yet Recruiting · Massachusetts General Hospital · Boston, Massachusetts