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Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging (EFMImaging)

This study has been withdrawn prior to enrollment.
(study close-out)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629914
First Posted: June 28, 2012
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
June 26, 2012
June 28, 2012
January 31, 2017
June 2012
January 2013   (Final data collection date for primary outcome measure)
change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal [ Time Frame: baseline and 8-weeks ]
Participants will be scanned prior to and following an 8-week group-based mindfulness meditation intervention
Same as current
Complete list of historical versions of study NCT01629914 on ClinicalTrials.gov Archive Site
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Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging
Executive Functioning and Mindfulness in Adults With ADHD Imaging
The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.

The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in executive brain functioning prior to and following an 8-week, group-based mindfulness meditation intervention within a group of 10 adults diagnosed with Attention-deficit/hyperactivity disorder (ADHD). Another group of 10 adults diagnosed with ADHD will be placed in the waitlist condition.

Our primary hypothesis is that adults with ADHD in the treatment group will exhibit improved performance on a series of executive functioning tasks and that exposure to task stimuli will correspond to changes in neural functioning following an 8-week, group-based mindfulness intervention. Brain responses will be measured using blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with emotional and executive processes prior to and following treatment.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Attention-deficit/Hyperactivity Disorder
Behavioral: Mindfulness Meditation
8-week, group-based mindfulness meditation intervention
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages 18-50 years
  • meet DSM-IV criteria for ADHD
  • intellectual functioning ≥ 80 as assessed by an IQ screener
  • generally healthy (i.e., no major medical problems)

Exclusion Criteria:

  • major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant), uncomfortable (e.g., chronic pain)
  • claustrophobic, or abnormally afraid of closed-in places
  • current drug use
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01629914
Pro00037192
No
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Duke University
Duke University
Not Provided
Principal Investigator: John T Mitchell, Ph.D Duke University
Duke University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP