Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

Conditions

• Repetitive Negative Thinking
• Serious Mental Illness Symptoms

Eligibility Criteria

Sex

ALL

Age

14 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Mindfulness Training — BEHAVIORAL
  All participants will complete a single 45-minute mindfulness training at Visit 2, with a refresher prior to the second mbNF session at Visit 3. 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.
• Active mindfulness-based neurofeedback (Active 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. Participants will be trained until they feel competent to use mental noting in the scanner. During active mbNF (6 runs, 2.5 minutes each), participants will use mental noting with the aim of controlling 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 — 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. Participants will be trained until they feel competent to use mental noting in the scanner. During sham mbNF, participants will view a visual display (white dot, red and blue circles) extracted from a previously acquired mbNF session. The 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 participants across groups are viewing equivalent stimuli for the same amount of overall time.

Study Details

The study will test the hypothesis that mindfulness-based neurofeedback (mbNF) will improve repetitive negative thinking and social and role functioning over sham neurofeedback in adolescents at risk for serious mental illness. To do so, 90 adolescents ages 14-21 with elevated repetitive negative thinking will be enrolled into a double-blind randomized clinical trial of sessions of mindfulness training with either active mindfulness-based neurofeedback or sham neurofeedback and three months of mindfulness practice and follow up.

Key Dates

Start date

Sep 30, 2027

Status verified

Jan 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Active mindfulness-based neurofeedback (Active mbNF)
  Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of active mindfulness-based neurofeedback
• Sham Comparator: Sham mindfulness-based neurofeedback (Sham mbNF)
  Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of sham neurofeedback

Primary Outcome Measure

Change in repetitive negative thinking (RNT) [ Time Frame: 2 weeks ]

Central Contacts

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

Locations (1)

Find similar trials in Boston, MA

Related Studies

• Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
  Recruiting · Massachusetts General Hospital · Boston, Massachusetts