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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Withdrawn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
Duke University
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 26, 2012
    Last Updated
    January 30, 2017
    Sponsor
    Duke University
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    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    Withdrawn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

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

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