iExposure for Social Anxiety

Overseen By Mikael Rubin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto University

Must not be taking: Psychotropics

Disqualifiers: CBT, Visual impairment, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

390 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your dose of psychotropic medications has been stable for at least 6 weeks before starting the trial.

What data supports the effectiveness of the iExposure treatment for social anxiety?

Research shows that Internet-based cognitive-behavioral therapy (CBT) is effective for social anxiety, with significant improvements in symptoms and quality of life. Studies also indicate that online self-help programs and videoconferencing therapies can be as effective as face-to-face treatments, making them promising options for those with social anxiety. ^{1 2 3 4 5}

Is iExposure safe for humans?

The available research does not provide specific safety data for iExposure or its related interventions. Further studies are needed to assess its safety in humans. ^{1 4 6 7 8}

What makes the iExposure treatment unique for social anxiety?

iExposure is unique because it uses simulated teleconferencing interactions to help people with social anxiety practice and improve their social skills in a safe, controlled online environment, which can be more accessible and less intimidating than in-person therapy. ^{2 5 6 9 10}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults over 18 who speak English and score higher than 47 on the Leibowitz Social Anxiety Scale, indicating they have social anxiety. They must also endorse social anxiety items on a specific web questionnaire.

Inclusion Criteria

Leibowitz Social Anxiety Scale > 47 and endorses both social anxiety items on the Web Screening Questionnaire for Common Mental Disorders

Fluent in English

Exclusion Criteria

I have or had bipolar disorder or psychosis.

Current alcohol or substance use disorder

I am currently undergoing cognitive behavioral therapy for social anxiety.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete four intervention sessions within two weeks using the iExposure protocol, with or without attention augmentations.

2 weeks

4 sessions (self-guided)

Follow-up

Participants are monitored for safety and effectiveness after treatment using various anxiety and depression scales.

6 weeks

Treatment Details

Interventions

• iExposure

Trial Overview The study tests iExposure therapy for social anxiety by comparing standard treatment to two variations: one with attention guidance and another with attention control, aiming to optimize treatment effectiveness.

Participant Groups

Group I: iExposure + Attention Guidance Augmentation Experimental Treatment 1 Intervention

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 II: iExposure + Attention Control Augmentation Experimental Treatment 1 Intervention

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 III: Standard iExposure Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Palo Alto University

Lead Sponsor

Trials

14

Recruited

8,100+

Findings from Research

Internet cognitive behavior therapy (CBT) and face-to-face CBT were equally effective in treating social phobia, as shown in a randomized controlled trial with 75 patients, where significant improvements were noted in both groups.

The Internet CBT required significantly less therapist time (18 minutes per patient) compared to face-to-face therapy (240 minutes per patient), suggesting that Internet CBT could allow for more efficient use of resources in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness randomized controlled trial of face to face versus Internet cognitive behaviour therapy for social phobia. Andrews, G., Davies, M., Titov, N.[2022]

The 'Talk to Me' Internet-based telepsychology program effectively treats fear of public speaking, showing equal efficacy whether self-administered or therapist-applied, based on a study with 127 participants.

Both treatment conditions significantly outperformed a waiting-list control group, and the benefits were maintained even after one year, highlighting the potential of Internet-delivered cognitive-behavioral therapy (CBT) to reach more individuals in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based self-help treatment for fear of public speaking: a controlled trial. Botella, C., Gallego, MJ., Garcia-Palacios, A., et al.[2019]

A 10-week internet-based self-help treatment for social phobia was effective in reducing symptoms across all groups, showing large effect sizes for both primary (Cohen's d=1.47) and secondary outcomes (d=1.16).

There were no significant differences in treatment outcomes between the unguided self-help group and those receiving minimal or flexible therapist support, suggesting that internet-delivered treatments can be effective even without direct therapist involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. Berger, T., Caspar, F., Richardson, R., et al.[2022]

A 9-week Internet-delivered self-help program combined with group exposure sessions significantly improved social anxiety, general anxiety, depression levels, and quality of life in 64 individuals with social phobia, with a strong effect size of Cohen's d = 0.87.

The treatment effects were not only significant but also maintained at a 1-year follow-up, supporting the effectiveness and sustainability of Internet-based interventions for social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. Andersson, G., Carlbring, P., Holmström, A., et al.[2022]

A pilot study involving 24 adults with generalized social anxiety disorder (SAD) demonstrated that a 12-session acceptance-based behavioral intervention delivered via Skype was both feasible and acceptable to participants and therapists.

Participants showed significant improvements in social anxiety, depression, disability, quality of life, and experiential avoidance, with effect sizes comparable to or larger than traditional in-person cognitive behavioral therapy (CBT) for SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance based behavior therapy for social anxiety disorder through videoconferencing. Yuen, EK., Herbert, JD., Forman, EM., et al.[2019]

The InterneT-based Stress test for Social Anxiety Disorder (ITSSAD) is a novel online procedure designed to study social anxiety disorder, which can be conducted remotely and efficiently by a single investigator.

In a pilot study with 20 volunteers showing symptoms of social anxiety disorder, the ITSSAD successfully induced significant anxiety and reduced positive feelings, indicating its potential as a reliable tool for researching social anxiety mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel procedure to investigate social anxiety using videoconferencing software: A proof-of-concept study. Huneke, NTM., Rowlatt, H., Hyde, J., et al.[2022]

The Social Phobia Scale (SPS) and Social Interaction Anxiety Scale (SIAS) are reliable tools for assessing social phobia, showing high internal consistency and test-retest reliability across various samples.

These scales effectively differentiate between social phobia and other anxiety disorders, and they demonstrate sensitivity to treatment changes, making them valuable for both clinical and research purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. Mattick, RP., Clarke, JC.[2022]

A systematic review of 51 randomized controlled trials involving 9914 participants found that pharmacotherapy for social anxiety disorder (SAD) is effective, with over 55% of participants responding positively to treatment after an average of 12 weeks.

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) were identified as the most effective and well-tolerated medication classes for SAD, while beta-blockers showed insufficient evidence for treating performance anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for social anxiety disorder: a systematic review. Ipser, JC., Kariuki, CM., Stein, DJ.[2018]

A new Videoconference Anxiety Scale was developed to assess the challenges faced by 598 children and adolescents with social anxiety during videoconferencing, highlighting the unique difficulties posed by this mode of communication.

The scale demonstrated strong validity and reliability, with a single factor explaining 52.95% of the variance, making it a useful tool for understanding social anxiety in the context of virtual interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Videoconference anxiety: Conceptualization, scale development, and preliminary validation. Gozpinar, N., Cakiroglu, S., Zorlu, A., et al.[2022]

Individuals with social anxiety disorder (SAD) preferred using voice/text mediums over visual mediums for social interactions, but using visual mediums led to immediate increases in positive perceptions and emotions.

The study, which involved 88 participants over 21 days, suggests that incorporating visual mediums into exposure interventions could enhance emotional responses and perceptions in individuals with SAD, potentially aiding in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Medium is the Message: Effects of Mediums of Communication on Perceptions and Emotions in Social Anxiety Disorder. Oren-Yagoda, R., Aderka, IM.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness randomized controlled trial of face to face versus Internet cognitive behaviour therapy for social phobia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Internet-based self-help treatment for fear of public speaking: a controlled trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Acceptance based behavior therapy for social anxiety disorder through videoconferencing. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

A novel procedure to investigate social anxiety using videoconferencing software: A proof-of-concept study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for social anxiety disorder: a systematic review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Videoconference anxiety: Conceptualization, scale development, and preliminary validation. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The Medium is the Message: Effects of Mediums of Communication on Perceptions and Emotions in Social Anxiety Disorder. [2021]