iExposure Intervention for Social Anxiety

Social Anxiety Clinical Trial

Official title:

Testing the Role of Attentional and Audio Vocal Mechanisms in a New Internet- Based Intervention for Social Anxiety: iExposure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409247
• Other study ID #: 2023-052-PAU
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Palo Alto University
• Contact: Mikael Rubin, phD
• Phone: 650-433-3805
• Email: mrubin[@]paloaltou.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• iExposure
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 guidance
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 control
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 days
Primary	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.	15 days
Primary	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.	45 days
Primary	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.	0 days
Primary	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.	15 days
Primary	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.	45 days
Secondary	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.	0 days
Secondary	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.	15 days
Secondary	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.	45 days