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

NCT ID: NCT01404273

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meditation/Relaxation Response Training

Group Type EXPERIMENTAL

Meditation/Relaxation Response Training

Intervention Type BEHAVIORAL

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

Interventions

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Meditation/Relaxation Response Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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George Bush

Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Bush, M.D.

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Benson-Henry Institute, 151 Merrimac St, 4th Floor

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009P002052

Identifier Type: -

Identifier Source: org_study_id