Functional MRI of Relaxation Response Training in Adults... | NCT01404273

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

NCT01404273

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 31, 2013Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

ADHD

Interventions

Meditation/Relaxation Response Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 25, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

George Bush, Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Centers for Disease Control and Prevention	FED

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Meditation/Relaxation Response Training	Experimental		Behavioral: Meditation/Relaxation Response Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meditation/Relaxation Response Training	Behavioral	1 hour weekly sessions with 20 min daily home practice for 6 weeks	Meditation/Relaxation Response Training

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Bush, M.D.	MGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benson-Henry Institute, 151 Merrimac St, 4th Floor		Boston	Massachusetts	02114	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019122	Meditation

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided