Muscle Relaxation Therapy With Odorant Cue

This study has been completed.

Sponsor:

Information provided by:

Emory University

ClinicalTrials.gov Identifier:

NCT00208910

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

November 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

PSWQ

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

HAM-A

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Muscle Relaxation Therapy With Odorant Cue

Official Title ^ICMJE

A Study of Enhancement of Progressive Muscle Relaxation Therapy for Generalized Anxiety Disorder Through Use Of An Odorant Cue.

Brief Summary

A novel procedure for generalized anxiety disorder where an odorant cue is paired with the state of deep relaxation during training. It is hypothesized that by smelling the odor in an anxiety-provoking situation, the patient will more easily invoke a state of relaxation, providing greater relief from the distressing tension and worry that characterize GAD.

Detailed Description

We hypothesize that by presenting a novel odor to a patient in a state of deep relaxation, the odor will serve as a conditioned inhibitory stimulus, or safety signal, in anxiety-provoking situations. With the odor serving as a contextual cue for the state of relaxation.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Generalized Anxiety Disorder
Anxiety

Intervention ^ICMJE

Behavioral: Odorant Cue

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

GAD without a comorbid active major psychiatric disorder.
GAD must be the primary active psychiatric disorder.
GAD determined via the Mini International Neuropsychiatric Interview (MINI).

Exclusion Criteria:

Significant medical illness that might interfere with the relaxation therapy or with training using the odorant.
Actively abusing alcohol.
Illicit substances.
Currently using rapid-acting anxiolytic agents (e.g. benzodiazepines, hydroxyzine).
Started an antidepressant, antipsychotic or mood stabilizing agent within three months of screening visit.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00208910

Other Study ID Numbers ^ICMJE

860-2003

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Philip T Ninan, MD

Emory University

Information Provided By

Emory University

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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