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: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Anxiety
Behavioral: Odorant Cue

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Study of Enhancement of Progressive Muscle Relaxation Therapy for Generalized Anxiety Disorder Through Use Of An Odorant Cue.

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • PSWQ

Secondary Outcome Measures:
  • HAM-A

Estimated Enrollment: 15
Study Start Date: November 2003
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208910

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Philip T Ninan, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208910     History of Changes
Other Study ID Numbers: 0860-2003
Study First Received: September 13, 2005
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Anxiety
Mental Health

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014