Attention-deficit/Hyperactivity DisorderEFMImagingNCT01629914
Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging
A study testing Mindfulness Meditation in people with Attention-deficit/Hyperactivity Disorder, run by Duke University.
Trial summary
The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Being tested
- Mindfulness Meditation
- Keywords
- Attention-deficit/hyperactivity disorder, executive functioning, mindfulness meditation, magnetic resonance imaging, healthy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
8-week, group-based mindfulness meditation intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: study close-out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John T Mitchell, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629914
- Sponsor's protocol ID
- Pro00037192
- Acronym
- EFMImaging
- Status last verified
- Jan 2013
- First submitted
- 26 Jun 2012
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning and Mindfulness in Adults With ADHD Imaging
- ClinicalTrials.gov ID
- NCT01629914
- Acronym / sponsor ID
- EFMImaging / Pro00037192
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Keywords
- Attention-deficit/hyperactivity disorder, executive functioning, mindfulness meditation, magnetic resonance imaging, healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study close-out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation8-week, group-based mindfulness meditation intervention | Behavioural | – |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John T Mitchell, Ph.D principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Attention-deficit/Hyperactivity Disorder, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal (time frame: baseline and 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.