Neural Effects of Mindfulness Training on Attention

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00379210

First received: September 20, 2006

Last updated: December 20, 2011

Last verified: November 2007

History of Changes

Results First Received: July 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Basic Science
Conditions:	No Condition Focus is Neural Effects of Mindfulness Training on Attention
Interventions:	Behavioral: Mindfulness Meditation Training (MMT) Behavioral: Nutrition Education course

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups

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

Participant Flow: Overall Study

	Mindfulness Training Group	Nutrition Education Group
STARTED	30	30
COMPLETED	20	23
NOT COMPLETED	10	7
Withdrawal by Subject	10	7

Baseline Characteristics

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Reporting Groups

	Description
Mindfulness Training Group	Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
Nutrition Education Group	Nutrition education group - received information about nutrition
Total	Total of all reporting groups

Baseline Measures

	Mindfulness Training Group	Nutrition Education Group	Total
Number of Participants [units: participants]	30	30	60
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	30	30	60
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	45 ± 11	46 ± 12	46 ± 12
Gender [units: participants]
Female	16	16	32
Male	14	14	28
Region of Enrollment [units: participants]
United States	30	30	60

Outcome Measures

1. Primary:

Reaction Times on the Sustained Attention to Response Task. [ Time Frame: 9 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Amishi Jha
Organization: University of Pennsylvania
phone: 215-898-8011
e-mail: apjha@psych.upenn.edu

No publications provided

Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00379210 History of Changes
Other Study ID Numbers:	R21 AT002761-01A1, R21AT002761-01A1, 10012037
Study First Received:	September 20, 2006
Results First Received:	July 20, 2010
Last Updated:	December 20, 2011
Health Authority:	United States: Institutional Review Board United States: Federal Government

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