StressATTENDNCT02413177
Augmenting Mindfulness Training Through Experience-driven Neurofeedback
A study testing EEG-no RTNF and EEG-RTNF in people with Stress, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The overall goal of the proposed study is to develop and test real time neurofeedback (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is based on the theoretical model that (1) mind-wandering and self-referential processing are associated with stress, (2) meditation redirects the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- EEG-no RTNF and EEG-RTNF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speakers (due to instructions provided in English)
- No history of neurological disorder
- Ability to understand the study procedures and willingness to commit to the demands of the study protocol.
- Remaining in the area for the duration of the study
- Willing to be randomized
Who cannot join
- Prior participation in an MBSR course.
- Regular meditation practice (or any other form of meditative practice, such as yoga, Tai Chi or contemplative prayer) for more than an average of 20 minutes a week within the past 2 years
- Participants with a serious psychiatric, cognitive or medical disorder which could interfere with completion of the study
- Unstable dose of psychotropic medication. Participants must be on a stable dose for the past three months
- Use of antipsychotic medication or stimulants
- Current alcohol use (>14/week or >4 drinks at any one time for a male, or >7 drinks/week or >3 drinks at any one time for a female)
Show all 9Show fewer
- Substance abuse (high frequency and problems caused) or dependence in the past 6 months;
- Claustrophobia
- MRI incompatible implants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
The overall goal of the proposed study is to develop and test real time neurofeedback (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is based on the theoretical model that (1) mind-wandering and self-referential processing are associated with stress, (2) meditation redirects the wandering mind toward present-centered awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN) involved in mind-wandering and self-referential processing, and thus (4) meditation leading to decreased activity in these hubs should lead to reduced stress and improved health and well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to real-world outcomes in reduced stress and improved attention.
Read the detailed description
Mindfulness Based Stress Reduction (MBSR) is an effective intervention for promoting positive cognitive and behavioral changes for improved health. However, MBSR delivery may be suboptimal. Recent work on potential neural mechanisms underlying the meditation practices that are core to MBSR may be utilized to improve MBSR delivery and efficacy. The investigators have shown recently that the posterior cingulate cortex (PCC), a brain region implicated in anxiety, addiction, Alzheimer's, ADHD, and other medical maladies, is selectively deactivated during three meditation practices that are core to MBSR suggesting a central role for the PCC in the neurobiology of MBSR. The investigators have also recently confirmed that PCC deactivation corresponds with the subjective experience of meditation in meditators. The proposed study will use EEG-RTNF from the PCC during meditation as an innovative strategy to augment MBSR and improve outcomes.
The task of mindfulness-the principle component of MBSR-is to maintain attention on and acceptance toward present-moment experience, and to redirect attention to one's immediate experience when it has strayed. This present-centered awareness may be considered a counterpoint to self-referential processing and mind-wandering. Consistent with a role for the PCC in mind-wandering, the PCC is specifically deactivated during three meditation practices (mindfulness of the breath, loving-kindness, and choiceless awareness) in experienced meditators compared to novices). Supporting these findings, a research study. showed that PCC deactivation during meditation correlated with a behavioral measure of attention (the Rapid Visual Information Processing Task, RVIP) in experienced meditators, suggesting that PCC deactivation is associated with improved attention in meditators. Another research study showed that the PCC is deactivated when experienced meditators mindfully view emotional images suggesting that PCC deactivation is associated with emotional stability and enhanced present-moment awareness.
EEG-RTNF is an emerging technology similar to classic biofeedback in which individuals receive moment-to-moment feedback of their brain activity during a particular task, typically by a dynamic visual display (e.g., a graph).
- Conditions
- Stress
- Being tested
- EEG-no RTNF, EEG-RTNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-no RTNFBehavioural
All EEG sessions are done on an individual basis. Group 2 will receive EEG (no RTNF) at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed.
EEG-RTNFBehavioural
All EEG sessions are done on an individual basis. Group 1 will receive EEG-RTNF training from the PCC at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed.
| Study group | Role | What they receive |
|---|---|---|
| EEG-RTNF | Active comparator | Group 1 will receive EEG-RTNF training from the PCC. They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7. Receives: Behavioral: EEG-RTNF |
| EEG-no RTNF | Active comparator | Group 2 will receive EEG (no RTNF feedback). They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7. Receives: Behavioral: EEG-no RTNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent signal change in the PCC as assessed by fMRI
will demonstrate that EEG-RTNF from the PCC augments MBSR as assessed by PCC deactivation during meditation
Measured: 12 weeks
Secondary outcomes (6)
Perceived stress scale (PSS) questionnaire scores,
Show that MBSR with EEG-RTNF from the PCC leads to reduced stress and improved attention
Measured: 5 and a half month
Rapid Visual Information Processing (RVIP): %hits,
Measured: 5 and a half month
Rapid Visual Information Processing (RVIP): number of false alarms
Measured: 5 and a half month
Rapid Visual Information Processing (RVIP): % of misses
Measured: 5 and a half month
Rapid Visual Information Processing (RVIP): reaction time in milliseconds to hits
Measured: 5 and a half month
Patient Recorded Outcomes Measurement Information System (PROMIS)- 29 question scores
Measured: 5 and a half month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Judson Brewer, University of Massachusetts, Worcester
- Investigators
- Judson Brewer, MD, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413177
- Sponsor's protocol ID
- AT007922
- Other IDs
- 7R01AT007922
- Acronym
- ATTEND
- Status last verified
- May 2018
- First submitted
- 9 Mar 2015
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Mindfulness Training Through Experience-driven Neurofeedback
- ClinicalTrials.gov ID
- NCT02413177
- Acronym / sponsor ID
- ATTEND / AT007922
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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 overall goal of the proposed study is to develop and test real time neurofeedback (EEG-RTNF) as a tool to augment Mindfulness Based Stress Reduction (MBSR). This study is based on the theoretical model that (1) mind-wandering and self-referential processing are associated with stress, (2) meditation redirects the wandering mind toward present-centered awareness, (3) meditation also decreases activity in hubs of the default mode network (DMN) involved in mind-wandering and self-referential processing, and thus (4) meditation leading to decreased activity in these hubs should lead to reduced stress and improved health and well-being. Milestones include: (1) test whether EEG-RTNF from the PCC during meditation augments MBSR in novices; and (2) test whether MBSR with EEG-RTNF from the PCC leads to real-world outcomes in reduced stress and improved attention.
Detailed description
Mindfulness Based Stress Reduction (MBSR) is an effective intervention for promoting positive cognitive and behavioral changes for improved health. However, MBSR delivery may be suboptimal. Recent work on potential neural mechanisms underlying the meditation practices that are core to MBSR may be utilized to improve MBSR delivery and efficacy. The investigators have shown recently that the posterior cingulate cortex (PCC), a brain region implicated in anxiety, addiction, Alzheimer's, ADHD, and other medical maladies, is selectively deactivated during three meditation practices that are core to MBSR suggesting a central role for the PCC in the neurobiology of MBSR. The investigators have also recently confirmed that PCC deactivation corresponds with the subjective experience of meditation in meditators. The proposed study will use EEG-RTNF from the PCC during meditation as an innovative strategy to augment MBSR and improve outcomes.
The task of mindfulness-the principle component of MBSR-is to maintain attention on and acceptance toward present-moment experience, and to redirect attention to one's immediate experience when it has strayed. This present-centered awareness may be considered a counterpoint to self-referential processing and mind-wandering. Consistent with a role for the PCC in mind-wandering, the PCC is specifically deactivated during three meditation practices (mindfulness of the breath, loving-kindness, and choiceless awareness) in experienced meditators compared to novices). Supporting these findings, a research study. showed that PCC deactivation during meditation correlated with a behavioral measure of attention (the Rapid Visual Information Processing Task, RVIP) in experienced meditators, suggesting that PCC deactivation is associated with improved attention in meditators. Another research study showed that the PCC is deactivated when experienced meditators mindfully view emotional images suggesting that PCC deactivation is associated with emotional stability and enhanced present-moment awareness.
EEG-RTNF is an emerging technology similar to classic biofeedback in which individuals receive moment-to-moment feedback of their brain activity during a particular task, typically by a dynamic visual display (e.g., a graph).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG-RTNF | Active comparator | Behavioral: EEG-RTNFGroup 1 will receive EEG-RTNF training from the PCC. They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7. |
| EEG-no RTNF | Active comparator | Behavioral: EEG-no RTNFGroup 2 will receive EEG (no RTNF feedback). They will attend an 8 week MBSR class. This feedback will occur at weeks 3, 4, 6 and 7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English speakers (due to instructions provided in English)
- No history of neurological disorder
- Ability to understand the study procedures and willingness to commit to the demands of the study protocol.
- Remaining in the area for the duration of the study
- Willing to be randomized
Key exclusion criteria (9 listed)
- Prior participation in an MBSR course.
- Regular meditation practice (or any other form of meditative practice, such as yoga, Tai Chi or contemplative prayer) for more than an average of 20 minutes a week within the past 2 years
- Participants with a serious psychiatric, cognitive or medical disorder which could interfere with completion of the study
- Unstable dose of psychotropic medication. Participants must be on a stable dose for the past three months
- Use of antipsychotic medication or stimulants
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 |
|---|---|---|
| EEG-no RTNFAll EEG sessions are done on an individual basis. Group 2 will receive EEG (no RTNF) at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed. | Behavioural | EEG-no RTNF |
| EEG-RTNFAll EEG sessions are done on an individual basis. Group 1 will receive EEG-RTNF training from the PCC at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed. | Behavioural | EEG-RTNF |
Primary outcome
percent signal change in the PCC as assessed by fMRI
Time frame: 12 weeks
will demonstrate that EEG-RTNF from the PCC augments MBSR as assessed by PCC deactivation during meditation
6 secondary outcomes
Perceived stress scale (PSS) questionnaire scores,
Time frame: 5 and a half month
Rapid Visual Information Processing (RVIP): %hits,
Time frame: 5 and a half month
Rapid Visual Information Processing (RVIP): number of false alarms
Time frame: 5 and a half month
Rapid Visual Information Processing (RVIP): % of misses
Time frame: 5 and a half month
Rapid Visual Information Processing (RVIP): reaction time in milliseconds to hits
Time frame: 5 and a half month
Patient Recorded Outcomes Measurement Information System (PROMIS)- 29 question scores
Time frame: 5 and a half month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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. This study is not recruiting at the moment.
Judson Brewer, MD, PhD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-no RTNF and EEG-RTNF in people with Stress, run by University of Massachusetts, Worcester 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 5 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: finished, as of the sponsor's last update on 30 May 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent signal change in the PCC as assessed by fMRI (time frame: 12 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 30 May 2018.