Muscle Relaxation Therapy With Odorant Cue

November 8, 2013 updated by: Emory University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PSWQ

Secondary Outcome Measures

Outcome Measure
HAM-A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Philip T Ninan, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0860-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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