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

January 30, 2017 updated by: Duke University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: John T Mitchell, Ph.D, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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