Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

NANot yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

September 30, 2027

Conditions
Repetitive Negative ThinkingSerious Mental Illness Symptoms
Interventions
BEHAVIORAL

Mindfulness Training

"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."

BEHAVIORAL

Active mindfulness-based neurofeedback (Active mbNF)

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.

BEHAVIORAL

Sham mindfulness-based neurofeedback

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.

Trial Locations (1)

02114

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT06901232 - Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents | Biotech Hunter | Biotech Hunter