ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01629914
Recruitment Status : Withdrawn (study close-out)
First Posted : June 28, 2012
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.

Condition or disease Intervention/treatment Phase
Attention-deficit/Hyperactivity Disorder Behavioral: Mindfulness Meditation Not Applicable

Detailed Description:

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.


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Executive Functioning and Mindfulness in Adults With ADHD Imaging
Study Start Date : June 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Behavioral: Mindfulness Meditation
    8-week, group-based mindfulness meditation intervention

Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629914


Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John T Mitchell, Ph.D Duke University
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01629914     History of Changes
Other Study ID Numbers: Pro00037192
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2013

Keywords provided by Duke University:
Attention-deficit/hyperactivity disorder
executive functioning
mindfulness meditation
magnetic resonance imaging
healthy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms