NCT00379210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

November 1, 2007

Enrollment Period

2.9 years

First QC Date

September 20, 2006

Results QC Date

July 20, 2010

Last Update Submit

December 20, 2011

Conditions

Keywords

AttentionERPevent-related potentialsfMRIfunctional magnetic resonance imagingMBSRMindfulness Based Stress ReductionMindfulness Meditation TrainingMMT

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 weeks

Study Arms (2)

1

EXPERIMENTAL

Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management. The meditation practice initially emphasized attention to a single focus. For most concentrative exercises, this focus was the breath. The sensations of breathing were to be examined closely, and when attention wandered it was to be redirected back to the breath. In other exercises, the focus of attention was to be directed to sensations within specific body parts (body scan exercise) and sensations of walking (walking meditation). During the 5th week of classes, the mindfulness training was expanded to include some explicit training in receptive attention.

Behavioral: Mindfulness Meditation Training (MMT)

2

ACTIVE COMPARATOR

Nutrition education group An active comparison condition involving nutrition education was offered. This course matched the mindfulness course in all dimensions including course duration, homework, psychosocial support, and teacher expertise. The course was taught by a nurse who had expertise in nutrition and offered a program described in the book, Nutrition for Life by Lisa Hark.

Behavioral: Nutrition Education course

Interventions

8-week training course in mindfulness meditation

Also known as: MBSR, Mindfulness-Based Stress Reduction
1

8-week course in nutrition

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Amishi Jha
Organization
University of Pennsylvania

Study Officials

  • Amishi P Jha, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 26, 2012

Results First Posted

January 26, 2012

Record last verified: 2007-11

Locations