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Neural Effects of Mindfulness Training on Attention

Neural Effects of Mindfulness Training on Attention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00379210
Enrollment
60
Registered
2006-09-21
Start date
2006-09-30
Completion date
2009-08-31
Last updated
2012-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus is Neural Effects of Mindfulness Training on Attention, No Condition

Keywords

Attention, ERP, event-related potentials, fMRI, functional magnetic resonance imaging, MBSR, Mindfulness Based Stress Reduction, Mindfulness Meditation Training, MMT

Brief summary

The purpose of this study is to examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention.

Detailed description

Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain, and adverse health symptoms in a varied subject population. MMT has been described as paying attention in a particular way. Although attention is a key component of meditation, little is known about the cognitive and neural changes within the human attention system that result from MMT. In this study, we examine the effects of MMT on the human attention system using neurobehavioral measures. Here MMT comprises participation in a Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in a nutrition education course, both 8 weeks long. We compare the performance and neural activity of these groups both before and after participation in the course.

Interventions

BEHAVIORALMindfulness Meditation Training (MMT)

8-week training course in mindfulness meditation

BEHAVIORALNutrition Education course

8-week course in nutrition

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Men and women (all races and ethnicities) between 18 and 40 years old * Women of childbearing age with a negative pregnancy test within 48 hours of scanning * In good health * Right-handed * Normal or corrected-to-normal vision * English as a first language * Able to understand and provide signed informed consent * No history of metal in their body or other reasons why they could not undergo an Magnetic Resonance Imaging * No history of ischemic or hemorrhagic stroke, encephalopathy or encephalitis, minimal-cognitive impairment or dementia, movement disorder such as Parkinson's disease, head trauma causing loss of consciousness, cancer involving the central nervous system

Exclusion criteria

* Pregnant or breast-feeding women * Individuals with implanted metal or electronic devices that would prevent them from MRI scanning. * Individuals with a history of neurologic dysfunction that would prevent performance on attentional tasks including: history of transient ischemic attacks, history of cerebral infarction, history of Binswanger's disease (or a history of hypertensive encephalopathy), history of intracranial hemorrhage, history of head trauma with loss of consciousness, history of encephalitis, history of extended exposure to any known neurotoxin, history of acquired cognitive impairment, history of normal pressure hydrocephalus, history of a cancer metastatic to the central nervous system, history of Parkinson's or other basal ganglia disease, history of Guillain-Barré syndrome or chronic or relapsing polyneuropathy

Design outcomes

Primary

MeasureTime frameDescription
Reaction Times on the Sustained Attention to Response Task.9 weeksSingle digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.

Countries

United States

Participant flow

Recruitment details

PI Laboratory at the University of Pennsylvania Round 1 of recruitment February 1-15, 2007 Round 2 of recruitment September 7-21, 2008

Pre-assignment details

Participants ages and gender were matched across groups. Significant prior experience with meditation or current or past neurological disorder or metal in body (for FMRI safety) were used as exclusion criteria

Participants by arm

ArmCount
Mindfulness Training Group
Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
30
Nutrition Education Group
Nutrition education group - received information about nutrition
30
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject107

Baseline characteristics

CharacteristicTotalMindfulness Training GroupNutrition Education Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
60 Participants30 Participants30 Participants
Age Continuous46 years
STANDARD_DEVIATION 12
45 years
STANDARD_DEVIATION 11
46 years
STANDARD_DEVIATION 12
Region of Enrollment
United States
60 participants30 participants30 participants
Sex: Female, Male
Female
32 Participants16 Participants16 Participants
Sex: Female, Male
Male
28 Participants14 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Reaction Times on the Sustained Attention to Response Task.

Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
Mindfulness Training GroupReaction Times on the Sustained Attention to Response Task.380 millisecondsStandard Deviation 24
Nutrition Education GroupReaction Times on the Sustained Attention to Response Task.407 millisecondsStandard Deviation 22
Comparison: Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha levelp-value: <0.01ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026