iExposure Intervention for Social Anxiety

Palo Alto University

Status: Enrolling

Conditions: Social Anxiety

Treatments: Behavioral: iExposure plus attention control; Behavioral: iExposure plus attention guidance; Behavioral: iExposure

Study type: Interventional

Funder types: Other

Identifiers

NCT06409247

2023-052-PAU

Details and patient eligibility

About

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).

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 3 patient groups

Standard iExposure

Active Comparator group

Description:

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.

Treatment:

Behavioral: iExposure

iExposure + Attention Guidance Augmentation

Experimental group

Description:

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.

Treatment:

Behavioral: iExposure plus attention guidance

iExposure + Attention Control Augmentation

Experimental group

Description:

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.

Treatment:

Behavioral: iExposure plus attention control