- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413177
Augmenting Mindfulness Training Through Experience-driven Neurofeedback (ATTEND)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts, Worcester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Substance abuse (high frequency and problems caused) or dependence in the past 6 months;
- Claustrophobia
- MRI incompatible implants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EEG-RTNF
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.
|
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.
|
Active Comparator: EEG-no RTNF
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived stress scale (PSS) questionnaire scores,
Time Frame: 5 and a half month
|
Show that MBSR with EEG-RTNF from the PCC leads to reduced stress and improved attention
|
5 and a half month
|
Rapid Visual Information Processing (RVIP): %hits,
Time Frame: 5 and a half month
|
5 and a half month
|
|
Rapid Visual Information Processing (RVIP): number of false alarms
Time Frame: 5 and a half month
|
5 and a half month
|
|
Rapid Visual Information Processing (RVIP): % of misses
Time Frame: 5 and a half month
|
5 and a half month
|
|
Rapid Visual Information Processing (RVIP): reaction time in milliseconds to hits
Time Frame: 5 and a half month
|
5 and a half month
|
|
Patient Recorded Outcomes Measurement Information System (PROMIS)- 29 question scores
Time Frame: 5 and a half month
|
5 and a half month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Judson Brewer, MD, PhD, UMass Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AT007922
- 7R01AT007922 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown
Clinical Trials on EEG-RTNF
-
Stanford UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingHealthy | Chronic Low-back PainUnited States
-
VA Office of Research and DevelopmentEnrolling by invitation
-
United States Naval Medical Center, San DiegoNaval Health Research CenterCompletedPTSD | Anxiety | Trauma | Sleep DisordersUnited States
-
Centre d'Investigation Clinique et Technologique...National Research Agency, FranceCompletedAttitude to ComputersFrance
-
Radboud University Medical CenterCompleted
-
McMaster UniversityCompletedNon-convulsive SeizuresCanada
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States, China
-
Mansoura University HospitalCompletedSpecific Language ImpairmentEgypt
-
Andrea Rossetti, MDCompletedComa | Outcome, Fatal | EEG With Abnormally Slow Frequencies | EEG With Periodic AbnormalitiesSwitzerland
-
Centre Hospitalier Universitaire de BesanconPlateforme NeuraxessRecruitingEmotional Regulation | Risk-TakingFrance