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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01629914
First received: June 26, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.


Condition Intervention
Attention-deficit/Hyperactivity Disorder
Behavioral: Mindfulness Meditation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Executive Functioning and Mindfulness in Adults With ADHD Imaging

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal [ Time Frame: baseline and 8-weeks ] [ Designated as safety issue: No ]
    Participants will be scanned prior to and following an 8-week group-based mindfulness meditation intervention


Enrollment: 0
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness Meditation
    8-week, group-based mindfulness meditation intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629914

Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John T Mitchell, Ph.D Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01629914     History of Changes
Other Study ID Numbers: Pro00037192
Study First Received: June 26, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014