Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
ADHD
Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
1 other identifier
interventional
12
1 country
1
Brief Summary
This research study is being done to examine how meditation and the relaxation response (RR) may change brain activity in attention-deficit/hyperactivity disorder (ADHD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJuly 31, 2013
July 1, 2013
2 years
July 25, 2011
July 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention
functional magnetic resonance imaging (fMRI) activation in dorsal anterior medial cingulate cortex (daMCC) \& dorsolateral prefrontal cortex (DLPFC) during multi-source interference task (MSIT)
2 sessions, 2 hours each to be conducted before and after the 6-week intervention
Study Arms (1)
Meditation/Relaxation Response Training
EXPERIMENTALInterventions
1 hour weekly sessions with 20 min daily home practice for 6 weeks
Eligibility Criteria
You may qualify if:
- Male or female adults (ages 18 - 49).
- Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by the Diagnostic and Statistics Manual of Mental Disorders (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.
You may not qualify if:
- Any current, non-ADHD Axis I psychiatric conditions
- Baseline Beck Depression Inventory (BDI) \> 19.
- Any clinically significant chronic medical condition.
- Mental retardation
- Organic brain disorders
- Seizures or tics.
- Pregnant or nursing females.
- Clinically unstable psychiatric conditions (suicidal behaviors, psychosis).
- Current or recent (within the past 2 years) substance abuse or dependence.
- Patients currently or recently (within past 1 month) on psychotropic medication.
- Subjects with current or prior adequate psychopharmacologic treatment for ADHD.
- Regular practice of an Relaxation Response-inducing technique within the past year
- History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Bush, M.D.
MGH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 28, 2011
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
July 31, 2013
Record last verified: 2013-07