Augmenting Mindfulness Training Through Experience-driven Neurofeedback

NCT02413177 | Completed DMC

• 2 other identifiers: AT0079227R01AT007922
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (6)

• Perceived stress scale (PSS) questionnaire scores,

  5 and a half month

• Rapid Visual Information Processing (RVIP): %hits,

  5 and a half month

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

  5 and a half month

• Rapid Visual Information Processing (RVIP): % of misses

  5 and a half month

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

  5 and a half month

Study Arms (2)

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.

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.

Behavioral: EEG-no RTNF

Interventions

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-no RTNF

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.

EEG-RTNF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Study Officials

• Judson Brewer, MD, PhD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine and Psychiatry

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

US (1)