[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585351":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":41,"locations":47,"responsibleParty":64,"collaborators":27,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":92,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Active mindfulness-based neurofeedback (Active mbNF)","EXPERIMENTAL","Participants will:\n\n* Receive a 45-minute mindfulness training\n* Receive two sessions of active mindfulness-based neurofeedback",[13,14],"Behavioral: Mindfulness Training","Behavioral: Active mindfulness-based neurofeedback (Active mbNF)",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham mindfulness-based neurofeedback (Sham mbNF)","SHAM_COMPARATOR","Participants will:\n\n* Receive a 45-minute mindfulness training\n* Receive two sessions of sham neurofeedback",[13,20],"Behavioral: Sham mindfulness-based neurofeedback",[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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\u002Fnote 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.",[9,16],null,{"type":23,"name":9,"description":29,"armGroupLabels":30,"otherNames":27},"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.",[9],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"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.",[16],[36,39],{"name":37,"affiliation":5,"role":38},"A. Eden Evins, MD, MPH","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Susan Whitfield-Gabrieli, PhD",[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Julia Jashinski, MSW","CONTACT","617-643-1984","jjashinski@mgh.harvard.edu",[48],{"facility":49,"status":27,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114","Boston","Massachusetts","02114","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-71.05977,42.35843,{"lat":59,"lon":58},[62,63],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},{"name":37,"role":38,"phone":27,"phoneExt":27,"email":27},{"type":38,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Anne Eden Evins","Founding Director Massachusetts General Hospital Center for Addiction Medicine; Cox Family Professor of Psychiatry, Harvard Medical School","100585351","mindfulness-based-neurofeedback-to-reduce-negative-thinking-in-charms-adolescents-100585351",false,"NCT06901232","Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents","Effect of Network-based Real Time Neurofeedback Augmentation of Mindfulness Practice on Recurrent Negative Thinking in Adolescents at Risk for Serious Mental Illness","CHARMS","Inclusion Criteria:\n\n* Ages 14-21, inclusive\n* Recurrent negative thinking, defined as PTQ-C (\\\u003C18 years) or PTQ (18 years or older) total score \\>30 and at least two questions scored 3 or 4.\n* Able to understand study procedures, read, and write in English\n* If age is 18 years or older: Competent and willing to provide written informed consent\n* If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent\u002Flegal guardian who is competent and willing to provide written informed consent\n* Access to a mobile device to complete daily survey assessments\n\nExclusion Criteria:\n\n* 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\n* Substance use disorder, moderate or severe in past six months.\n* Unstable medical or neurologic condition, epilepsy or seizure disorder, head injury, loss of consciousness \\>5 minutes\n* 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).\n* Visual, auditory, or cognitive impairment (IQ\\\u003C80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to participate.\n* Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.\n* Pregnancy; a negative pregnancy test is required at enrollment\n* Individuals who are under the legal protection of the government or state (Wards of the State)\n* Inability to speak, read, or write English fluently","ALL","14 Years","21 Years",{"count":79,"type":80},90,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.",[86,87],"Repetitive Negative Thinking","Serious Mental Illness Symptoms",[89,90,91],"Mindfulness","Repetitive negative thinking","Serious mental illness symptoms","NOT_YET_RECRUITING","2026-02-10",{"date":95,"type":96},"2026-02-12","ACTUAL",{"date":98,"type":80},"2027-09",{"date":100,"type":80},"2029-04",{"name":5,"class":6},1]