Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Training, Active mindfulness-based neurofeedback (Active mbNF), Sham mindfulness-based neurofeedback.
- Who it may be relevant to
- Registry conditions: Repetitive Negative Thinking, Serious Mental Illness Symptoms. Basic parameters: 14 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Network-based Real Time Neurofeedback Augmentation of Mindfulness Practice on Recurrent Negative Thinking in Adolescents at Risk for Serious Mental Illness
Overview
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.
Detailed description
Approximately 90 at-risk adolescents ages 14-21 years old will be enrolled in a double-blind, randomized clinical trial. All participants will undergo a baseline clinical assessment (Visit 1), which will serve as an important baseline for daily symptom fluctuation and use of mindfulness strategies prior to training. Approximately 1-2 weeks after the baseline assessments, all participants will complete an in-person visit (Visit 2) in which they will complete a brief MRI scan (resting state localizer) and a 45-minute mindfulness training. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback (n=45 each group). Randomization will be stratified by information obtained at the baseline assessment: biological sex, prior daily/near daily mindfulness practice for 8 weeks or more. A study staff member with no participant contact will create randomization tables in REDCap to alloacte participants to either active or sham mbNF. Participants and staff will remain blinded to assignment. Participants will then complete another MRI session what will include resting state scans as well as the active or sham mbNF. Approximately 1-2 weeks later, participants will return for another in-person visit (Visit 3) that includes a mindfulness refresher and repeats the procedures of Visit 2. Participants will briefly rate their mindfulness practice daily for three months using a brief, online survey. At 1-, 3- and 12-months post-neurofeedback, participants will complete self-report and clinician-rated assessments to probe repetitive negative thinking and prodromal psychiatric 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' - 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 t - 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 b
Primary outcome measures
- Change in repetitive negative thinking (RNT) [Time frame: 2 weeks]
Secondary outcome measures (5)
- Change in psychotic symptom severity [Time frame: 2 weeks]
- Change in depressive symptom severity [Time frame: 2 weeks]
- Change in social and occupational functioning [Time frame: 2 weeks]
- Change in worry symptom severity [Time frame: 2 weeks]
- Change in rumination symptom severity [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- Ages 14-21, inclusive
- Recurrent negative thinking, defined as PTQ-C (<18 years) or PTQ (18 years or older) total score >30 and at least two questions scored 3 or 4.
- Able to understand study procedures, read, and write in English
- If age is 18 years or older: Competent and willing to provide written informed consent
- If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
- Access to a mobile device to complete daily survey assessments
Exclusion criteria
- Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, oppositional defiant disorder, 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, 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 enrollment
- Individuals who are under the legal protection of the government or state (Wards of the State)
- Inability to speak, read, or write English fluently
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite — Boston
Identifiers
NCT: NCT06901232 · 2024P003611