Trial Outcomes & Findings for Neural Effects of Mindfulness Training on Attention (NCT NCT00379210)

NCT ID: NCT00379210

Last Updated: 2012-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

9 weeks

Results posted on

2012-01-26

Participant Flow

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

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

Participant milestones

Participant milestones
Measure
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
Overall Study
STARTED
30
30
Overall Study
COMPLETED
20
23
Overall Study
NOT COMPLETED
10
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Overall Study
Withdrawal by Subject
10
7

Baseline Characteristics

Neural Effects of Mindfulness Training on Attention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness Training Group
n=30 Participants
Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
Nutrition Education Group
n=30 Participants
Nutrition education group - received information about nutrition
Total
n=60 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=99 Participants
30 Participants
n=107 Participants
60 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age Continuous
45 years
STANDARD_DEVIATION 11 • n=99 Participants
46 years
STANDARD_DEVIATION 12 • n=107 Participants
46 years
STANDARD_DEVIATION 12 • n=206 Participants
Sex: Female, Male
Female
16 Participants
n=99 Participants
16 Participants
n=107 Participants
32 Participants
n=206 Participants
Sex: Female, Male
Male
14 Participants
n=99 Participants
14 Participants
n=107 Participants
28 Participants
n=206 Participants
Region of Enrollment
United States
30 participants
n=99 Participants
30 participants
n=107 Participants
60 participants
n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness Training Group
n=30 Participants
Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
Nutrition Education Group
n=30 Participants
Nutrition education group - received information about nutrition
Reaction Times on the Sustained Attention to Response Task.
380 milliseconds
Standard Deviation 24
407 milliseconds
Standard Deviation 22

Adverse Events

Mindfulness Training Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Nutrition Education Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amishi Jha

University of Pennsylvania

Phone: 215-898-8011

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place