Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging (EFMImaging)
Primary Purpose
Attention-deficit/Hyperactivity Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Meditation
Sponsored by
About this trial
This is an interventional other trial for Attention-deficit/Hyperactivity Disorder focused on measuring Attention-deficit/hyperactivity disorder, executive functioning, mindfulness meditation, magnetic resonance imaging, healthy
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal
Participants will be scanned prior to and following an 8-week group-based mindfulness meditation intervention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01629914
Brief Title
Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging
Acronym
EFMImaging
Official Title
Executive Functioning and Mindfulness in Adults With ADHD Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
study close-out
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder
Keywords
Attention-deficit/hyperactivity disorder, executive functioning, mindfulness meditation, magnetic resonance imaging, healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
8-week, group-based mindfulness meditation intervention
Primary Outcome Measure Information:
Title
change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal
Description
Participants will be scanned prior to and following an 8-week group-based mindfulness meditation intervention
Time Frame
baseline and 8-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John T Mitchell, Ph.D
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging
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