- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379210
Neural Effects of Mindfulness Training on Attention
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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. |
8-week training course in mindfulness meditation
Other Names:
|
Active Comparator: 2
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. |
8-week course in nutrition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction Times on the Sustained Attention to Response Task.
Time Frame: 9 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amishi P Jha, Ph.D., University of Pennsylvania
Publications and helpful links
Helpful Links
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21AT002761-01A1 (U.S. NIH Grant/Contract)
- 10012037
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.
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