Predictors of Exposure Success in Public Speaking Anxiety

Performance Anxiety Clinical Trial

Official title:

Predictors of Exposure Success in Public Speaking Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163148
• Other study ID #: UCSDIRB-130313
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: May 26, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Anxiety disorders are common and impairing. Although exposure therapy is one of the most effective treatments for anxiety, some individuals do not fully respond to treatment, and these individual differences are not well understood. Exposure therapy involves repeated, deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This treatment is thought to work through a type of emotional learning called fear extinction. This study aims to look at links between fear extinction learning and exposure success, with the overall goal of better understanding who is likely to respond best to exposure therapy and why.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Score of at least 20 on the PRCS

• Age 18-55

• English fluency

Exclusion Criteria:

• Psychotropic medication use in the past 4 weeks

• Past experience with exposure based therapy

• History of bipolar disorder, psychotic disorder, or substance dependence

• Current major depressive disorder of greater than moderate severity (defined as a score on the 9 item Patient Health Questionnaire of greater than 14)

• Clinically significant suicidal or homicidal ideation

• Non-removable ferrous metal

• Current significant neurological conditions

• History of loss of consciousness greater than 5 minutes duration

• Pregnant

• Claustrophobic

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anxiety Disorders
• Performance Anxiety

Intervention

Behavioral:
• Massed speech exposure session
One session consisting of 4 speech exposures, each 5 minutes long.

Locations

Country	Name	City	State
United States	UCSD Psychiatry Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline on the Sheehan Disability Scale (SDS) at week 2		Baseline, week 2	No
Primary	Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure	Participants will complete 4 exposures during one 90 minute session. Change in the peak ratings on the final exposure relative to the first exposure will be the outcome measure.	90 minutes	No
Secondary	Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks		Baseline, week 2	No
Secondary	Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks		Baseline, week 2	No