Social Anxiety DisorderSAVRNCT04288180
Social Anxiety Virtual Reality Study
An observational study of Social Anxiety Disorder, run by Stanford University at 1 site in United States.
Trial summary
This project aims to validate a virtual reality paradigm that assesses maladaptive avoidance behavior in social anxiety disorder. It also aims to generate a significant scientific advance by testing the hypothesis that maladaptive avoidance maintains anxiety through disruptions in safety learning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 28 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with primary social anxiety disorder, community sample
Who may be able to join
- age 18+
- primary diagnosis of social anxiety disorder
- fluent spoken and written English
- able to provide informed consent
Who cannot join
- history of manic episode, hypomanic episode, or psychosis
- moderate or severe substance use disorder in the past 12 months
- current major depressive episode greater than moderate severity (PHQ-9 score >14)
- high risk for suicide (>8 on the MINI Suicidality section and/or clinician judgment that immediate medical attention is necessary)
- general medical condition or impediment to vision, hearing, or motor function likely to interfere with assessments
- benzodiazepine use in the past 2 weeks
- cannabis use for anxiety management in the past 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder
This project aims to validate a virtual reality paradigm that assesses maladaptive avoidance behavior in social anxiety disorder. It also aims to generate a significant scientific advance by testing the hypothesis that maladaptive avoidance maintains anxiety through disruptions in safety learning.
Read the detailed description
Although occasional mild social anxiety is a common human experience, social anxiety disorder has a devastating impact on patients' lives, leaving them vulnerable to medical, psychiatric, and socioeconomic complications. A key feature of social anxiety disorder is avoidance of social and/or performance situations in which judgment and evaluation from others might occur. Reducing avoidance is therefore an important treatment goal.
Despite the importance of avoidance, however, it is very difficult to assess a patient's tendency to avoid. Many prior assessments of avoidance measure adaptive (i.e., helpful) avoidance, in which an individual learns to avoid a truly noxious stimulus. However, anxiety disorders are characterized by maladaptive avoidance, in which a relatively safe stimulus is avoided resulting in interference with the individual's goals. In this study, the first aim is to validate a virtual reality paradigm to measure maladaptive avoidance behavior in adults with social anxiety disorder. The second aim is to test whether maladaptive avoidance behavior relates to safety learning (measured by a fear extinction task).
- Conditions
- Social Anxiety Disorder
- Being tested
- No intervention
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no intervention in this study. Adults with social anxiety disorder will complete research assessments related to fear and safety learning.
| Study group | Role | What they receive |
|---|---|---|
| Social Anxiety Disorder | A group of adults with social anxiety disorder will be recruited for a psychological/behavioral research study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maladaptive Avoidance Behavior
Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task
Measured: Baseline
Secondary outcomes (2)
Maladaptive Avoidance Behavior (alternate measure)
Amount of time (in milliseconds) spent in the quadrant of the avoidance task containing the image from the fear learning task
Measured: Baseline
Maladaptive Avoidance Behavior (2nd alternate measure)
Amount of time (in milliseconds) with center of gaze on the image from the fear learning task
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start15 Jan 2020
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tali Manber Ball, PhD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288180
- Sponsor's protocol ID
- IRB-48367
- Acronym
- SAVR
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maladaptive Avoidance and Fear Conditioning in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT04288180
- Acronym / sponsor ID
- SAVR / IRB-48367
- Conditions
- Social Anxiety Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 28 Feb 2020 (actual)
- 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.
This project aims to validate a virtual reality paradigm that assesses maladaptive avoidance behavior in social anxiety disorder. It also aims to generate a significant scientific advance by testing the hypothesis that maladaptive avoidance maintains anxiety through disruptions in safety learning.
Detailed description
Although occasional mild social anxiety is a common human experience, social anxiety disorder has a devastating impact on patients' lives, leaving them vulnerable to medical, psychiatric, and socioeconomic complications. A key feature of social anxiety disorder is avoidance of social and/or performance situations in which judgment and evaluation from others might occur. Reducing avoidance is therefore an important treatment goal.
Despite the importance of avoidance, however, it is very difficult to assess a patient's tendency to avoid. Many prior assessments of avoidance measure adaptive (i.e., helpful) avoidance, in which an individual learns to avoid a truly noxious stimulus. However, anxiety disorders are characterized by maladaptive avoidance, in which a relatively safe stimulus is avoided resulting in interference with the individual's goals. In this study, the first aim is to validate a virtual reality paradigm to measure maladaptive avoidance behavior in adults with social anxiety disorder. The second aim is to test whether maladaptive avoidance behavior relates to safety learning (measured by a fear extinction task).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Anxiety Disorder | – | Other: No interventionA group of adults with social anxiety disorder will be recruited for a psychological/behavioral research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with primary social anxiety disorder, community sample
Key inclusion criteria (4 listed)
- age 18+
- primary diagnosis of social anxiety disorder
- fluent spoken and written English
- able to provide informed consent
Key exclusion criteria (7 listed)
- history of manic episode, hypomanic episode, or psychosis
- moderate or severe substance use disorder in the past 12 months
- current major depressive episode greater than moderate severity (PHQ-9 score >14)
- high risk for suicide (>8 on the MINI Suicidality section and/or clinician judgment that immediate medical attention is necessary)
- general medical condition or impediment to vision, hearing, or motor function likely to interfere with assessments
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 |
|---|---|---|
| No interventionThere will be no intervention in this study. Adults with social anxiety disorder will complete research assessments related to fear and safety learning. | Other | Social Anxiety Disorder |
Primary outcome
Maladaptive Avoidance Behavior
Time frame: Baseline
Latency (in milliseconds) to enter the quadrant of the avoidance task containing the image from the fear learning task
2 secondary outcomes
Maladaptive Avoidance Behavior (alternate measure)
Time frame: Baseline
Maladaptive Avoidance Behavior (2nd alternate measure)
Time frame: Baseline
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Social Anxiety Disorder, run by Stanford University 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 Oct 2021. 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 was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
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?
Maladaptive Avoidance Behavior (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.