- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163148
Predictors of Exposure Success in Public Speaking Anxiety
May 26, 2015 updated by: Tali Manber Ball, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92037
- UCSD Psychiatry Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Public Speaking Anxiety
Intervention to be administered: One speech exposure session.
|
One session consisting of 4 speech exposures, each 5 minutes long.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure
Time Frame: 90 minutes
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks
Time Frame: Baseline, week 2
|
Baseline, week 2
|
|
Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks
Time Frame: Baseline, week 2
|
Baseline, week 2
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline on the Sheehan Disability Scale (SDS) at week 2
Time Frame: Baseline, week 2
|
Baseline, week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tali M Ball, MA, UCSD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
June 11, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (ESTIMATE)
June 13, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSDIRB-130313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Performance Anxiety
-
Centro Universitário Augusto MottaActive, not recruitingNeuromodulation | Performance Anxiety | Musical PerformanceBrazil
-
University of SalamancaRecruitingStress | Anxiety | Academic PerformanceSpain
-
Karolinska InstitutetCompletedMental Health | Performance Anxiety | Performance EnhancementSweden
-
Jess WallsNot yet recruitingAnxiety | Performance Anxiety | Well-Being (Psychological Flourishing)United States
-
Vanda PharmaceuticalsCompletedPerformance AnxietyUnited States
-
Charite University, Berlin, GermanyFriede Springer Stiftung, GermanyCompleted
-
Wuerzburg University HospitalRecruitingMusic Performance AnxietyGermany
-
Grigore T. Popa University of Medicine and PharmacyRomanian Academy; Socola Institute of PsychiatryActive, not recruitingPerformance AnxietyRomania
-
Florida International UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedAnxiety | Academic PerformanceUnited States
-
University of FloridaRecruitingAnxiety | Mood | Cognitive Performance | MemoryUnited States
Clinical Trials on Massed speech exposure session
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Medical University of South CarolinaRalph H. Johnson VA Medical CenterWithdrawnPosttraumatic Stress Disorder
-
University of PennsylvaniaThe University of Texas Health Science Center at San Antonio; U.S. Army Medical...CompletedPosttraumatic Stress Disorders | Combat DisordersUnited States
-
Syracuse UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
-
Emory UniversityCompleted
-
GCS Ramsay Santé pour l'Enseignement et la RechercheEuraxi PharmaWithdrawn
-
Virginia Polytechnic Institute and State UniversityNational Institute of Mental Health (NIMH)CompletedAnxiety Disorders | Specific PhobiaUnited States
-
Hebrew University of JerusalemRecruiting
-
Boston University Charles River CampusThe University of Hong Kong; Tufts University; University of Arizona; University... and other collaboratorsCompletedPublic Speaking | Speech AnxietyUnited States, Australia, Netherlands, China, Germany
-
Rutgers, The State University of New JerseyNational Institute of Mental Health (NIMH); University of California, San Diego and other collaboratorsRecruitingTrauma and Stressor Related Disorders | Substance Use Disorders (SUD) | Posttraumatic Stress Disorder (PTSD) | ComorbidityUnited States