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CompletedNCT01404273ADHDUpdated Jul 31, 2013

Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

An interventional study of Meditation/Relaxation Response Training in ADHD, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2013-07-31.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
All
01

Study 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).

02

Conditions studied

  • ADHD
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's enrollment of 12 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female adults (ages 18 - 49).
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Any current, non-ADHD Axis I psychiatric conditions
  2. Baseline Beck Depression Inventory (BDI) > 19.
  3. Any clinically significant chronic medical condition.
  4. Mental retardation
  5. Organic brain disorders
  6. Seizures or tics.
  7. Pregnant or nursing females.
  8. Clinically unstable psychiatric conditions (suicidal behaviors, psychosis).
  9. Current or recent (within the past 2 years) substance abuse or dependence.
  10. Patients currently or recently (within past 1 month) on psychotropic medication.
  11. Subjects with current or prior adequate psychopharmacologic treatment for ADHD.
  12. Regular practice of an Relaxation Response-inducing technique within the past year
  13. History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Meditation/Relaxation Response Training

    Behavioral: Meditation/Relaxation Response Training

Interventions

  • BehavioralMeditation/Relaxation Response Training

    1 hour weekly sessions with 20 min daily home practice for 6 weeks

06

What researchers measure

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)

    Time frame: 2 sessions, 2 hours each to be conducted before and after the 6-week intervention

07

Study locations

1 site
  • Benson-Henry Institute, 151 Merrimac St, 4th Floor
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01404273
Lead sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention
Responsible party
George Bush (Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH, Massachusetts General Hospital) — Principal investigator
First posted
Jul 28, 2011
Start date
Sep 2009
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 31, 2013

Study contacts

George Bush, M.D.
principal investigator · MGH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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