Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

Not Applicable

Not yet recruiting

• Conditions: Repetitive Negative Thinking; Serious Mental Illness Symptoms

• Registration Number: NCT06901232
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in repetitive negative thinking (RNT)	2 weeks	Perseverative Thinking Questionnaire- Child Version (PTQ-C), is a content-independent measure of RNT, with 15 items, rated on a 5- point scale (never, almost never, sometimes, often, almost always), with excellent internal consistency, Cronbach's alpha=0.95, in both clinical and non-clinical samples, validated and normed in clinical and non-clinical adolescent and young adult samples as a transdiagnostic research tool that has been shown to predict MDD. Higher scores indicate greater RNT.

Secondary Outcome Measures

Name	Time	Method
Change in psychotic symptom severity	2 weeks	Psychotic symptoms will be assessed using the Brief Psychiatric Rating Scale (BPRS), a well validated, 18-item, interview-based measure of positive and negative psychotic, depressive, and general psychiatric symptoms that is sensitive to treatment effects and is included in the PhenXToolkit. Scores for each item range from 1 (not present) and 7 (extremely severe). Higher scores indicate greater severity of psychotic symptoms.
Change in depressive symptom severity	2 weeks	Depressive symptoms will be assessed by the Quick Inventory of Depressive Symptoms - (QIDS-C) for participants ages 18 and older and the Quick Inventory of Depressive Symptoms - Adolescent Version (QIDS-A17) for participants under 18 years old. The QIDS is a 17-item clinician rated scale that assesses mood, sleep, appetite, and suicidal ideation. Higher scores indicate greater depressive symptom severity.
Change in social and occupational functioning	2 weeks	Social and occupational functioning will be assessed using the Social and Occupational Functioning Assessment Scale (SOFAS). It focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Scores range from 0 to 100, with lower scores indicating greater levels of impairment.
Change in worry symptom severity	2 weeks	The Penn State Worry Questionnaire will be used to assess RNT in the form of worry. The scale has a possible range from 0 to 42. Severity cutoffs are as follows: normal (0-15), at risk (top 3-7%; 16-18), clinically elevated (top 2%; 19+). Participants under 18 years old will be assessed using the Penn State Worry Questionnaire for Children.
Change in rumination symptom severity	2 weeks	The Rumination Response Scale (RRS) will be used to assess RNT in the form of depressive content and response styles for depression. The scale is 22 items and each item is rated on a 4-point Likert scale, with responses ranging from 1 (almost never) to 4 (almost always). Higher scores indicate more severe rumination responses.

Trial Locations

Locations (1)

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114; 🇺🇸 Boston, Massachusetts, United States