Back to resultsMuscle Relaxation Therapy With Odorant Cue
Primary Purpose
Generalized Anxiety Disorder, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Odorant Cue
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Anxiety, Mental Health
Eligibility 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.
Sites / Locations
- Emory University School of Medicine
Outcomes
Primary Outcome Measures
PSWQ
Secondary Outcome Measures
HAM-A
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00208910
Brief Title
Muscle Relaxation Therapy With Odorant Cue
Official Title
A Study of Enhancement of Progressive Muscle Relaxation Therapy for Generalized Anxiety Disorder Through Use Of An Odorant Cue.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Emory University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Anxiety
Keywords
Anxiety, Mental Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Odorant Cue
Primary Outcome Measure Information:
Title
PSWQ
Secondary Outcome Measure Information:
Title
HAM-A
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T Ninan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Muscle Relaxation Therapy With Odorant Cue
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