NCT00208910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

First QC Date

September 13, 2005

Last Update Submit

November 8, 2013

Conditions

Generalized Anxiety DisorderAnxiety

Keywords

AnxietyMental Health

Outcome Measures

Primary Outcomes (1)

  • PSWQ

Secondary Outcomes (1)

  • HAM-A

Interventions

Odorant CueBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Philip T Ninan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Study Completion

May 1, 2005

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

US(1)