iExposure Intervention for Social Anxiety

NCT ID: NCT06409247

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-06-30

Brief 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).

Conditions

Social Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard iExposure

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.

Group Type: ACTIVE_COMPARATOR

iExposure

Intervention Type: BEHAVIORAL

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 + Attention Guidance Augmentation

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.

Group Type: EXPERIMENTAL

iExposure plus attention guidance

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

iExposure plus attention control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palo Alto University

OTHER

Sponsor Role: lead

Responsible Party

Mikael Rubin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Palo Alto University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mikael Rubin, PhD

Role: CONTACT

mrubin@paloaltou.edu

650-433-3805

Facility Contacts

Mikael Rubin, PhD

Role: primary

mrubin@paloaltou.edu

650-433-3805

Other Identifiers

2023-052-PAU

Identifier Type: -

Identifier Source: org_study_id