Muscle Relaxation Therapy With Odorant Cue

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208910
• Other study ID #: 0860-2003
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 8, 2013
• Start date: November 2003
• Est. completion date: May 2005

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• Odorant Cue

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSWQ
Secondary	HAM-A