Back to resultsFunctional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation/Relaxation Response Training
Sponsored by
About this trial
This is an interventional treatment trial for ADHD
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Benson-Henry Institute, 151 Merrimac St, 4th Floor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meditation/Relaxation Response Training
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01404273
First Posted
July 25, 2011
Last Updated
July 29, 2013
Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01404273
Brief Title
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
Acronym
ADHD
Official Title
Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meditation/Relaxation Response Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Meditation/Relaxation Response Training
Intervention Description
1 hour weekly sessions with 20 min daily home practice for 6 weeks
Primary Outcome Measure Information:
Title
Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Bush, M.D.
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benson-Henry Institute, 151 Merrimac St, 4th Floor
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
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