Repetitive Negative ThinkingCHARMSNCT06901232
Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
A study testing Mindfulness Training and Active mindfulness-based neurofeedback (Active mbNF) in people with Repetitive Negative Thinking and Serious Mental Illness Symptoms, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Repetitive Negative Thinking, Serious Mental Illness Symptoms
- What is being tested?
- Mindfulness Training and Active mindfulness-based neurofeedback (Active mbNF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2027to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
Boston, Massachusetts, 02114
Julia Jashinski, MSW, 617-643-1984, jjashinski@mgh.harvard.edu
A. Eden Evins, MD, MPH
About this study
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
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.
Read the 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.
- Being tested
- Mindfulness Training, Active mindfulness-based neurofeedback (Active mbNF), Sham mindfulness-based neurofeedback
- Keywords
- Mindfulness, Repetitive negative thinking, Serious mental illness symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
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)Behavioural
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 neurofeedbackBehavioural
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 group | Role | What they receive |
|---|---|---|
| Active mindfulness-based neurofeedback (Active mbNF) | Experimental | Participants will:
* Receive a 45-minute mindfulness training
* Receive two sessions of active mindfulness-based neurofeedback Receives: Behavioral: Mindfulness Training; Behavioral: Active mindfulness-based neurofeedback (Active mbNF) |
| Sham mindfulness-based neurofeedback (Sham mbNF) | Sham comparator | Participants will:
* Receive a 45-minute mindfulness training
* Receive two sessions of sham neurofeedback Receives: Behavioral: Mindfulness Training; Behavioral: Sham mindfulness-based neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in repetitive negative thinking (RNT)
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.
Measured: 2 weeks
Secondary outcomes (5)
Change in psychotic symptom severity
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.
Measured: 2 weeks
Change in depressive symptom severity
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.
Measured: 2 weeks
Change in social and occupational functioning
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.
Measured: 2 weeks
Change in worry symptom severity
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.
Measured: 2 weeks
Change in rumination symptom severity
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study startSep 2027 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Negative ThinkingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Eden Evins, Massachusetts General Hospital
- Investigators
- A. Eden Evins, MD, MPH, Principal investigator, Massachusetts General HospitalSusan Whitfield-Gabrieli, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901232
- Sponsor's protocol ID
- 2024P003611
- Acronym
- CHARMS
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available upon request. Data will include de-identified individual patient-level data and a data dictionary. Investigators proposing to use the data must execute a data use agreement with Massachusetts General Hospital and have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, before data is shared. Data will be available within three months of manuscript publication. Requests for data should be sent to aeevins@mgh.harvard.edu.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06901232
- Acronym / sponsor ID
- CHARMS / 2024P003611
- Keywords
- Mindfulness, Repetitive negative thinking, Serious mental illness symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active mindfulness-based neurofeedback (Active mbNF) | Experimental | Behavioral: Mindfulness Training, Behavioral: Active mindfulness-based neurofeedback (Active mbNF)Participants will: * Receive a 45-minute mindfulness training * Receive two sessions of active mindfulness-based neurofeedback |
| Sham mindfulness-based neurofeedback (Sham mbNF) | Sham comparator | Behavioral: Mindfulness Training, Behavioral: Sham mindfulness-based neurofeedbackParticipants will: * Receive a 45-minute mindfulness training * Receive two sessions of sham neurofeedback |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingAll 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. | Behavioural | Active mindfulness-based neurofeedback (Active mbNF), Sham mindfulness-based neurofeedback (Sham mbNF) |
| 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. | Behavioural | Active mindfulness-based neurofeedback (Active mbNF) |
| Sham mindfulness-based neurofeedbackBefore 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. | Behavioural | Sham mindfulness-based neurofeedback (Sham mbNF) |
Primary outcome
Change in repetitive negative thinking (RNT)
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available upon request. Data will include de-identified individual patient-level data and a data dictionary. Investigators proposing to use the data must execute a data use agreement with Massachusetts General Hospital and have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, before data is shared. Data will be available within three months of manuscript publication. Requests for data should be sent to aeevins@mgh.harvard.edu.
Related trials for Repetitive Negative Thinking
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Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
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Not yet recruiting
Calming Minds Study
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RecruitingObservational study
Emotion Regulation in RNT
Repetitive Negative Thinking, Healthy Controls Group - Age and Sex-matched
Recruiting
Group-Based Acceptance and Commitment Therapy Versus Active Control in University Students With Emotional Symptoms
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A. Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
Susan Whitfield-Gabrieli, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Active mindfulness-based neurofeedback (Active mbNF) in people with Repetitive Negative Thinking and Serious Mental Illness Symptoms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Jashinski, MSW (617-643-1984, jjashinski@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in repetitive negative thinking (RNT) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.