Performance AnxietyNCT02163148
Predictors of Exposure Success in Public Speaking Anxiety
An observational study of Performance Anxiety, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Performance Anxiety
- What is being tested?
- Massed speech exposure session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community sample
Who may be able to join
- Score of at least 20 on the PRCS
- Age 18-55
- English fluency
Who cannot join
- 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
Show all 10Show fewer
- Current significant neurological conditions
- History of loss of consciousness greater than 5 minutes duration
- Pregnant
- Claustrophobic
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Psychiatry Research
San Diego, California, 92037
About this study
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.
- Conditions
- Performance Anxiety
- Being tested
- Massed speech exposure session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massed speech exposure sessionBehavioural
One session consisting of 4 speech exposures, each 5 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| Public Speaking Anxiety | Intervention to be administered: One speech exposure session. Receives: Behavioral: Massed speech exposure session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (2)
Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks
Measured: Baseline, week 2
Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks
Measured: Baseline, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Performance AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tali Manber Ball, University of California, San Diego
- Investigators
- Tali M Ball, MA, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163148
- Sponsor's protocol ID
- UCSDIRB-130313
- Status last verified
- May 2015
- First submitted
- 11 Jun 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ball TM, Knapp SE, Paulus MP, Stein MB. Brain activation during fear extinction predicts exposure success. Depress Anxiety. 2017 Mar;34(3):257-266. doi: 10.1002/da.22583. Epub 2016 Dec 6.
PubMed 27921340
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Exposure Success in Public Speaking Anxiety
- ClinicalTrials.gov ID
- NCT02163148
- Acronym / sponsor ID
- UCSDIRB-130313
- Conditions
- Performance Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Public Speaking Anxiety | – | Behavioral: Massed speech exposure sessionIntervention to be administered: One speech exposure session. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Score of at least 20 on the PRCS
- Age 18-55
- English fluency
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massed speech exposure sessionOne session consisting of 4 speech exposures, each 5 minutes long. | Behavioural | Public Speaking Anxiety |
Primary outcome
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.
2 secondary outcomes
Change from baseline on the Liebowitz Social Anxiety Scale (LSAS) at 2 weeks
Time frame: Baseline, week 2
Change from baseline on the Personal Report of Confidence as a Speaker (PRCS) at 2 weeks
Time frame: Baseline, week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 27921340Ball TM, Knapp SE, Paulus MP, Stein MB. Brain activation during fear extinction predicts exposure success. Depress Anxiety. 2017 Mar;34(3):257-266. doi: 10.1002/da.22583. Epub 2016 Dec 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tali M Ball, MA principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Performance Anxiety, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak Subjective Unit of Distress (SUDS) rating from first to fourth (last) exposure (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.