Skip to main content
OpenTrials
Completed

NCT Number: NCT02413177

Augmenting Mindfulness Training Through Experience-driven Neurofeedback

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG-no RTNF

Behavioral

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-RTNF

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Rapid Visual Information Processing (RVIP): %hits,

    Time frame: 5 and a half month

  3. Rapid Visual Information Processing (RVIP): number of false alarms

    Time frame: 5 and a half month

  4. Rapid Visual Information Processing (RVIP): % of misses

    Time frame: 5 and a half month

  5. Rapid Visual Information Processing (RVIP): reaction time in milliseconds to hits

    Time frame: 5 and a half month

  6. Patient Recorded Outcomes Measurement Information System (PROMIS)- 29 question scores

    Time frame: 5 and a half month

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: ATTEND

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 9, 2015
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.