NCT01629914

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

June 26, 2012

Last Update Submit

January 30, 2017

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorderexecutive functioningmindfulness meditationmagnetic resonance imaginghealthy

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline and 8-weeks

Interventions

Mindfulness MeditationBEHAVIORAL

8-week, group-based mindfulness meditation intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • John T Mitchell, Ph.D

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 31, 2017

Record last verified: 2013-01