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This study has been withdrawn prior to enrollment.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

History of Changes

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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Diagnostic Imaging

U.S. FDA Resources

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:

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

ClinicalTrials.gov processed this record on February 27, 2015

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