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

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).

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Meditation/Relaxation Response Training

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation/Relaxation Response Training	Behavioral: Meditation/Relaxation Response Training; 1 hour weekly sessions with 20 min daily home practice for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: George Bush, M.D., MGH

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2009P002052