Social AnxietyNCT06409247
iExposure Intervention for Social Anxiety
A study testing iExposure and iExposure plus attention guidance in people with Social Anxiety, run by Palo Alto University at 1 site in United States.
Trial summary
Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety
- What is being tested?
- iExposure and iExposure plus attention guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 18 or older
- Fluent in English
- Leibowitz Social Anxiety Scale > 47 and endorses both social anxiety items on the Web Screening Questionnaire for Common Mental Disorders
Who cannot join
- Currently receiving CBT for Social Anxiety Disorder
- Significant visual impairment precluding engagement in the simulated teleconferencing interactions
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
- Current alcohol or substance use disorder
- Current or past bipolar disorder or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Role of Attentional and Audio Vocal Mechanisms in a New Internet- Based Intervention for Social Anxiety: iExposure
Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Despite the prevalence of SA, as few as one in five individuals receive care, due to limited access to evidence-based treatments. Additionally there has been a notable increase in social anxiety since the start of the COVID-19 pandemic. This proposal will use iExposure to develop a personalized mechanism-focused approach to optimizing treatment response for individuals with social anxiety by testing standard iExposure against two augmentations that incorporate distinct attention mechanisms (attention guidance and attention control).
- Conditions
- Social Anxiety
- Being tested
- iExposure, iExposure plus attention guidance, iExposure plus attention control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iExposureBehavioural
There will be 4 treatment sessions, covering the iExposure intervention. The intervention and assessment process is entirely self-guided. Each session will last approximately 60 minutes. Participants will complete 10 mock-interaction trials for each session.
iExposure plus attention guidanceBehavioural
The attention guidance condition consists of two unique components in addition to the standard iExposure intervention: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given a target audience member to focus their gaze on during each impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. In each progressive session the number of trials where the participant is directed to focus on an uninterested audience member will increase.
iExposure plus attention controlBehavioural
The attention control condition consists of two unique components in addition to the standard iExposure intervention (1) the intervention rationale will include information about the importance of developing attention control; (2) participants will be given a central region of the screen (non-audience member) to focus on. They will be told that they should look at and focus on the central region for the whole response.
| Study group | Role | What they receive |
|---|---|---|
| Standard iExposure | Active comparator | iExposure. Participants will complete four intervention sessions within two weeks. The intervention will use an entirely self-guided protocol delivered via Qualtrics and Gorilla Experiment Builder:
1. During the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure.
2. Participants will then complete 10 simulated teleconferencing interaction trials with different topics, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members to respond to a question (described in further detail in the Materials section, below).
3. Participants will complete the Subjective Units of Distress Scale before and after each speech trial.
4. Sessions 2-4 involve the same protocol and the four intervention sessions are completed within two weeks. Receives: Behavioral: iExposure |
| iExposure + Attention Guidance Augmentation | Experimental | Attention Guidance Augmentation. The attention guidance condition consists of two unique components in addition to the standard iExposure intervention: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given a target audience member to focus their gaze on during each impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. In each progressive session the number of trials where the participant is directed to focus on an uninterested audience member will increase. Receives: Behavioral: iExposure plus attention guidance |
| iExposure + Attention Control Augmentation | Experimental | The attention control condition consists of two unique components in addition to the standard iExposure intervention (1) the intervention rationale will include information about the importance of developing attention control; (2) participants will be given a central region of the screen (non-audience member) to focus on. They will be told that they should look at and focus on the central region for the whole response. Receives: Behavioral: iExposure plus attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale Self Report Version
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Measured: 0 days
Liebowitz Social Anxiety Scale Self Report Version
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Measured: 15 days
Liebowitz Social Anxiety Scale Self Report Version
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Measured: 45 days
Personal Report of Communication Apprehension (PRCA)
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
Measured: 0 days
Personal Report of Communication Apprehension
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
Measured: 15 days
Personal Report of Communication Apprehension
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
Measured: 45 days
Secondary outcomes (3)
Center for Epidemiologic Studies Depression Scale - Revised
The Center for Epidemiologic Studies Depression Scale - Revised is a 20-item measure of depression. The range of scores is 0-60; higher scores are worse.
Measured: 0 days
Center for Epidemiologic Studies Depression Scale - Revised
The Center for Epidemiologic Studies Depression Scale - Revised is a 20-item measure of depression. The range of scores is 0-60; higher scores are worse.
Measured: 15 days
Center for Epidemiologic Studies Depression Scale - Revised
The Center for Epidemiologic Studies Depression Scale - Revised is a 20-item measure of depression. The range of scores is 0-60; higher scores are worse.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jul 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael Rubin, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409247
- Sponsor's protocol ID
- 2023-052-PAU
- Status last verified
- Mar 2026
- First submitted
- 7 May 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared as part of the National Institute of Mental Health Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Role of Attentional and Audio Vocal Mechanisms in a New Internet- Based Intervention for Social Anxiety: iExposure
- ClinicalTrials.gov ID
- NCT06409247
- Acronym / sponsor ID
- 2023-052-PAU
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Palo Alto UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 10 May 2024 (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.
Social anxiety (SA) is a highly prevalent mental health concern, thought to disproportionately affect youth with recent international estimates of more than 30% of individuals reporting clinically elevated symptoms. Despite the prevalence of SA, as few as one in five individuals receive care, due to limited access to evidence-based treatments. Additionally there has been a notable increase in social anxiety since the start of the COVID-19 pandemic. This proposal will use iExposure to develop a personalized mechanism-focused approach to optimizing treatment response for individuals with social anxiety by testing standard iExposure against two augmentations that incorporate distinct attention mechanisms (attention guidance and attention control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard iExposure | Active comparator | Behavioral: iExposureiExposure. Participants will complete four intervention sessions within two weeks. The intervention will use an entirely self-guided protocol delivered via Qualtrics and Gorilla Experiment Builder: 1. During the first session, participants will receive a brief standardized psychoeducation module, presented via a 15-minute video recording. This video will explain the intervention, its rationale, and the procedure. 2. Participants will then complete 10 simulated teleconferencing interaction trials with different topics, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members to respond to a question (described in further detail in the Materials section, below). 3. Participants will complete the Subjective Units of Distress Scale before and after each speech trial. 4. Sessions 2-4 involve the same protocol and the four intervention sessions are completed within two weeks. |
| iExposure + Attention Guidance Augmentation | Experimental | Behavioral: iExposure plus attention guidanceAttention Guidance Augmentation. The attention guidance condition consists of two unique components in addition to the standard iExposure intervention: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given a target audience member to focus their gaze on during each impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. In each progressive session the number of trials where the participant is directed to focus on an uninterested audience member will increase. |
| iExposure + Attention Control Augmentation | Experimental | Behavioral: iExposure plus attention controlThe attention control condition consists of two unique components in addition to the standard iExposure intervention (1) the intervention rationale will include information about the importance of developing attention control; (2) participants will be given a central region of the screen (non-audience member) to focus on. They will be told that they should look at and focus on the central region for the whole response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Fluent in English
- Leibowitz Social Anxiety Scale > 47 and endorses both social anxiety items on the Web Screening Questionnaire for Common Mental Disorders
Key exclusion criteria (5 listed)
- Currently receiving CBT for Social Anxiety Disorder
- Significant visual impairment precluding engagement in the simulated teleconferencing interactions
- Unstable dose of psychotropic medications within 6 weeks prior to baseline assessment
- Current alcohol or substance use disorder
- Current or past bipolar disorder or psychosis
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 |
|---|---|---|
| iExposureThere will be 4 treatment sessions, covering the iExposure intervention. The intervention and assessment process is entirely self-guided. Each session will last approximately 60 minutes. Participants will complete 10 mock-interaction trials for each session. | Behavioural | Standard iExposure |
| iExposure plus attention guidanceThe attention guidance condition consists of two unique components in addition to the standard iExposure intervention: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given a target audience member to focus their gaze on during each impromptu response. They will be told that they should look at and focus on the target audience member for the whole response. In each progressive session the number of trials where the participant is directed to focus on an uninterested audience member will increase. | Behavioural | iExposure + Attention Guidance Augmentation |
| iExposure plus attention controlThe attention control condition consists of two unique components in addition to the standard iExposure intervention (1) the intervention rationale will include information about the importance of developing attention control; (2) participants will be given a central region of the screen (non-audience member) to focus on. They will be told that they should look at and focus on the central region for the whole response. | Behavioural | iExposure + Attention Control Augmentation |
Primary outcome
Liebowitz Social Anxiety Scale Self Report Version
Time frame: 0 days
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Liebowitz Social Anxiety Scale Self Report Version
Time frame: 15 days
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Liebowitz Social Anxiety Scale Self Report Version
Time frame: 45 days
The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.
Personal Report of Communication Apprehension (PRCA)
Time frame: 0 days
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
Personal Report of Communication Apprehension
Time frame: 15 days
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
Personal Report of Communication Apprehension
Time frame: 45 days
The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.
3 secondary outcomes
Center for Epidemiologic Studies Depression Scale - Revised
Time frame: 0 days
Center for Epidemiologic Studies Depression Scale - Revised
Time frame: 15 days
Center for Epidemiologic Studies Depression Scale - Revised
Time frame: 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared as part of the National Institute of Mental Health Data Archive
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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?
A study testing iExposure and iExposure plus attention guidance in people with Social Anxiety, run by Palo Alto 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Liebowitz Social Anxiety Scale Self Report Version (time frame: 0 days). The study lists 6 primary outcomes in all. 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 9 Mar 2026.