Repetitive Negative ThinkingCHARMSNCT07055217
Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
A study testing Mindfulness Training and Mindfulness-based Neurofeedback (Real mbNF) in people with Repetitive Negative Thinking and Neurofeedback, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer… Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Repetitive Negative Thinking, Neurofeedback
- What is being tested?
- Mindfulness Training and Mindfulness-based Neurofeedback (Real mbNF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to Apr 2027
- 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 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 13-21, inclusive
- If <18 years old: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
- If age ≥18 years: Competent and willing to provide written informed consent
- Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
- Able to understand study procedures, read, and write in English
- Access to a mobile device to complete daily surveys
Show all 9Show fewer
- Additional Inclusion Criteria for At-Risk Adolescents - Recurrent negative thinking, defined as PTQ/PTQ-C total score >30 with at least two items rated as 3 (Often) or 4 (Almost Always)
- Additional Inclusion Criteria for Healthy Controls
- -PTQ/PTQ-C total score <15, with zero items rated as 3 (Often) or 4 (Always)
Who cannot join
- Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major depressive disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or obsessive compulsive disorder
- Severe lifetime substance use disorder
- Unstable medical or neurologic condition as determined by study staff, history of epilepsy or seizure disorder, head injury, loss of consciousness >5 minutes by participant self-report
- 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 the time of enrollment for any individuals of childbearing potential
- Individuals who are under the legal protection of the government or state (Wards of the State)
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, 1 recruiting
- Recruiting
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
This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer session of mindfulness based neurofeedback will lead to greater reduction in DMN connectivity. To do so, 50 adolescents with elevated repetitive negative thinking and 50 matched healthy control participants will be enrolled into a double-blind randomized clinical trial of a session of mindfulness training with either active mindfulness-basde neurofeedback or sham mindfulness-based neurofeedback.
Read the detailed description
A sample of 50 at-risk adolescents with elevated repetitive negative thinking and 50 matched healthy control participants, ages 13-21, will be enrolled into this double blind, randomized clinical trial. Healthy control participants will be matched for age and sex. All participants will complete a baseline clinical assessment and return within two weeks for a brief resting state MRI scan to assess default mode connectivity (DMN). At Visit 2, at-risk adolescents will then receive a 45-minute mindfulness training by clinically trained staff. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback. Participants and staff will remain blind to assignment. Participants will have fMRI scans for resting state functional connectivity before and after mindfulness practice. Participants will complete two doses (15 minutes per dose) of real or sham mbNF in the scanner. At-risk adolescents will also complete a follow-up clinical assessment at 4-weeks post-scan (Visit 3) and complete daily surveys for approximately four weeks from Visit 2 to Visit 3.
- Conditions
- Repetitive Negative Thinking, Neurofeedback
- Being tested
- Mindfulness Training, Mindfulness-based Neurofeedback (Real mbNF), Sham mindfulness-based neurofeedback (Sham mbNF)
- Keywords
- Adolescents at risk for serious mental illness, Mindfulness, Real-time fMRI, Neurofeedback, DMN Connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
A single 45-minute mindfulness training will be provided to all at-risk participants at visit 2. 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.
Mindfulness-based Neurofeedback (Real 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. All participants will be trained until they feel competent to use mental noting in the scanner. Study clinicians will show 85% fidelity on the mindfulness training assessment before working with participants and sessions will be recorded and 10% of sessions will be assessed quarterly for fidelity. During active mbNF (6 runs, 2.5 mins each), participants will use mental noting with the aim of controlling the 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 neurofeedback (Sham mbNF)Behavioural
During sham mbNF condition, participants will undergo similar MRI scan procedures. The primary difference in scan procedures is that rather than receiving mbNF, participants will view a visual display (i.e., white dot, red and blue circles) extracted from a previously acquired mbNF session. Thus, the visual 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 that participants across groups are viewing equivalent stimuli for the same amount of overall time.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control (HC) | No intervention | Healthy control participants will complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity. They will receive no intervention or comparator. |
| Mindfulness-based neurofeedback (mbNF) | Experimental | Participants will:
* Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity
* Receive a 45-minute mindfulness training
* Receive two 15-minute sessions of mindfulness-based neurofeedback Receives: Behavioral: Mindfulness Training; Behavioral: Mindfulness-based Neurofeedback (Real mbNF) |
| Sham mindfulness-based neurofeedback (Sham mbNF) | Sham comparator | Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback Receives: Behavioral: Mindfulness Training; Behavioral: Sham mindfulness-based neurofeedback (Sham mbNF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting State Default Mode Network (DMN) Functional Connectivity
We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Measured: Baseline
Change in Within-Person Default Mode Network (DMN) Functional Connectivity
A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.
Measured: Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)
Time Effect on Within-DMN Connectivity
A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Measured: Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start4 Nov 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT07055217
- Sponsor's protocol ID
- 2025P001338
- Other IDs
- R61MH139856
- Acronym
- CHARMS
- Status last verified
- May 2026
- First submitted
- 10 Jun 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a large database where de-identified study data from many NIH-funded studies are stored and managed. The final dataset to be shared will include demographic, clinical (diagnostic interviews, questionnaires), and neuroimaging (MRI and fMRI) data collected from at-risk adolescents and healthy controls. Sufficient data from this project to validate and replicate findings described in the aims will be shared. The study protocol will be published as a methods/protocol paper. We will also publish and maintain detailed neurofeedback experiment data (including stimuli, experiment scripts, and analysis scripts) on GitHub.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
- ClinicalTrials.gov ID
- NCT07055217
- Acronym / sponsor ID
- CHARMS / 2025P001338
- Conditions
- Repetitive Negative Thinking, Neurofeedback
- Keywords
- Adolescents at risk for serious mental illness, Mindfulness, Real-time fMRI, Neurofeedback, DMN Connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Jul 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.
This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer session of mindfulness based neurofeedback will lead to greater reduction in DMN connectivity. To do so, 50 adolescents with elevated repetitive negative thinking and 50 matched healthy control participants will be enrolled into a double-blind randomized clinical trial of a session of mindfulness training with either active mindfulness-basde neurofeedback or sham mindfulness-based neurofeedback.
Detailed description
A sample of 50 at-risk adolescents with elevated repetitive negative thinking and 50 matched healthy control participants, ages 13-21, will be enrolled into this double blind, randomized clinical trial. Healthy control participants will be matched for age and sex. All participants will complete a baseline clinical assessment and return within two weeks for a brief resting state MRI scan to assess default mode connectivity (DMN). At Visit 2, at-risk adolescents will then receive a 45-minute mindfulness training by clinically trained staff. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback. Participants and staff will remain blind to assignment. Participants will have fMRI scans for resting state functional connectivity before and after mindfulness practice. Participants will complete two doses (15 minutes per dose) of real or sham mbNF in the scanner. At-risk adolescents will also complete a follow-up clinical assessment at 4-weeks post-scan (Visit 3) and complete daily surveys for approximately four weeks from Visit 2 to Visit 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control (HC) | No intervention | –Healthy control participants will complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity. They will receive no intervention or comparator. |
| Mindfulness-based neurofeedback (mbNF) | Experimental | Behavioral: Mindfulness Training, Behavioral: Mindfulness-based Neurofeedback (Real mbNF)Participants will: * Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity * Receive a 45-minute mindfulness training * Receive two 15-minute sessions of mindfulness-based neurofeedback |
| Sham mindfulness-based neurofeedback (Sham mbNF) | Sham comparator | Behavioral: Mindfulness Training, Behavioral: Sham mindfulness-based neurofeedback (Sham mbNF)Participants will: - Complete a brief resting state MRI scan at Visit 2 to assess default mode network connectivity -Receive a 45-minute mindfulness training -Receive two 15-minute sessions of sham mindfulness-based neurofeedback |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Ages 13-21, inclusive
- If <18 years old: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
- If age ≥18 years: Competent and willing to provide written informed consent
- Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
- Able to understand study procedures, read, and write in English
Key exclusion criteria (8 listed)
- Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major depressive disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or obsessive compulsive disorder
- Severe lifetime substance use disorder
- Unstable medical or neurologic condition as determined by study staff, history of epilepsy or seizure disorder, head injury, loss of consciousness >5 minutes by participant self-report
- 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 TrainingA single 45-minute mindfulness training will be provided to all at-risk participants at visit 2. 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 | Mindfulness-based neurofeedback (mbNF), Sham mindfulness-based neurofeedback (Sham mbNF) |
| Mindfulness-based Neurofeedback (Real 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. All participants will be trained until they feel competent to use mental noting in the scanner. Study clinicians will show 85% fidelity on the mindfulness training assessment before working with participants and sessions will be recorded and 10% of sessions will be assessed quarterly for fidelity. During active mbNF (6 runs, 2.5 mins each), participants will use mental noting with the aim of controlling the 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 | Mindfulness-based neurofeedback (mbNF) |
| Sham mindfulness-based neurofeedback (Sham mbNF)During sham mbNF condition, participants will undergo similar MRI scan procedures. The primary difference in scan procedures is that rather than receiving mbNF, participants will view a visual display (i.e., white dot, red and blue circles) extracted from a previously acquired mbNF session. Thus, the visual 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 that participants across groups are viewing equivalent stimuli for the same amount of overall time. | Behavioural | Sham mindfulness-based neurofeedback (Sham mbNF) |
Primary outcome
Resting State Default Mode Network (DMN) Functional Connectivity
Time frame: Baseline
We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
Change in Within-Person Default Mode Network (DMN) Functional Connectivity
Time frame: Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)
A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.
Time Effect on Within-DMN Connectivity
Time frame: Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)
A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).
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 19 May 2026.
- Individual participant dataSharing planned: Yes. Data from this study will be submitted to the National Institute of Mental Health Data Archive (NDA). NDA is a large database where de-identified study data from many NIH-funded studies are stored and managed. The final dataset to be shared will include demographic, clinical (diagnostic interviews, questionnaires), and neuroimaging (MRI and fMRI) data collected from at-risk adolescents and healthy controls. Sufficient data from this project to validate and replicate findings described in the aims will be shared. The study protocol will be published as a methods/protocol paper. We will also publish and maintain detailed neurofeedback experiment data (including stimuli, experiment scripts, and analysis scripts) on GitHub.
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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 Mindfulness-based Neurofeedback (Real mbNF) in people with Repetitive Negative Thinking and Neurofeedback, 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 May 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?
Resting State Default Mode Network (DMN) Functional Connectivity (time frame: Baseline). The study lists 3 primary outcomes in all. 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 19 May 2026.