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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
George Bush, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01404273
First received: July 25, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
ADHD
Behavioral: Meditation/Relaxation Response Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention [ Time Frame: 2 sessions, 2 hours each to be conducted before and after the 6-week intervention ] [ Designated as safety issue: No ]
    functional magnetic resonance imaging (fMRI) activation in dorsal anterior medial cingulate cortex (daMCC) & dorsolateral prefrontal cortex (DLPFC) during multi-source interference task (MSIT)


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation/Relaxation Response Training Behavioral: Meditation/Relaxation Response Training
1 hour weekly sessions with 20 min daily home practice for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404273

Locations
United States, Massachusetts
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: George Bush, M.D. MGH
  More Information

No publications provided

Responsible Party: George Bush, Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01404273     History of Changes
Other Study ID Numbers: 2009P002052
Study First Received: July 25, 2011
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014