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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called iExposure, a type of therapy designed to help people with social anxiety feel more comfortable in social situations. Researchers aim to determine if adding special focus techniques can enhance the treatment's effectiveness. The trial consists of three parts: standard iExposure, iExposure with attention control (focusing on a neutral spot), and iExposure with attention guidance (focusing on audience members' faces). Individuals who experience significant anxiety in social settings and are not currently receiving therapy may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative therapy techniques for social anxiety.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that iExposure is generally easy to use and safe. In past studies, participants used this online method to manage social anxiety, with most reporting no serious side effects. They typically engaged in video call simulations, which reduced their anxiety with minimal discomfort. This method not only decreased symptoms but also proved user-friendly, suggesting its safety. It is currently being tested in other studies for social anxiety, supporting its potential as a safe way to manage this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about iExposure for social anxiety because it offers a new approach to managing this condition through self-guided, technology-driven interventions. Unlike traditional therapies like cognitive-behavioral therapy (CBT) or medication, which require in-person sessions or pharmacological interventions, iExposure delivers the treatment via an online platform. This method empowers users to engage with the treatment at their own pace and convenience. Additionally, the trial explores unique enhancements: one version focuses on improving attention control by directing gaze to a neutral area, while another guides participants to focus on audience faces, potentially enhancing engagement skills. These innovative approaches could offer more personalized and accessible ways to help those with social anxiety.

What evidence suggests that this trial's treatments could be effective for social anxiety?

Research has shown that iExposure can help reduce symptoms of social anxiety. In this trial, participants may receive the standard iExposure intervention, iExposure with attention control augmentation, or iExposure with attention guidance augmentation. One study found that participants using the attention control version of iExposure experienced a significant decrease in social anxiety compared to those using the standard version, meaning they felt less anxious. However, the attention guidance version did not offer extra benefits over the standard iExposure. These findings suggest that iExposure, especially with attention control, could be an effective treatment for social anxiety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Current alcohol or substance use disorder

I have or had bipolar disorder or psychosis.

I am currently undergoing cognitive behavioral therapy for social anxiety.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39625833/

An initial test of a new self-guided internet-based ... This randomized clinical trial aimed at testing two mechanism-driven exposure augmentation strategies for social anxiety. Participants (N = 53) were randomized ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04729803

Attention, Teleconferencing and Social Anxiety Experimental : Attention Guidance + Exposure. Participants will complete teleconferencing-based exposure trials with an attention guidance component. ; Active ...

3. researchgate.net researchgate.net/publication/381571318_An_initial_test_of_a_new_self-guided_internet-based_intervention_for_social_anxiety_iExposure

An initial test of a new self-guided internet-based ... The attention control condition led to larger reductions in social anxiety compared to standard iExposure d = -0.81 and attention guidance did not enhance ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10097519/

Multimodal Remote Research on Social Anxiety Using a ... In the current paper we focus first on showing that the simulated teleconferencing interactions were realistic and effective at eliciting fear.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04850989

Efficacy of Virtual Reality Exposure Therapy Scripts for ... The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in social anxiety disorder (SAD).

6. cognbehavther.com cognbehavther.com/an-initial-test-of-a-new-self-guided-internet-based-intervention-for-social-anxiety-iexposure/

An initial test of a new self-guided internet-based intervention ... This study tested whether using simulated teleconferencing interactions (where you pretend like you are on a social zoom call) could help reduce symptoms of ...

7. ctv.veeva.com ctv.veeva.com/study/iexposure-intervention-for-social-anxiety

iExposure Intervention for Social Anxiety - ClinicalTrials.Veeva Participants will then complete 10 simulated teleconferencing interaction trials with different topics, each lasting a maximum of two minutes.

8. semanticscholar.org semanticscholar.org/paper/786d7a2fa6eecd6db4db33a99abe563183e95897

An initial test of a new self-guided internet-based ... In conclusion, ICBT is effective in the reduction of social anxiety symptoms and future research should focus on what makes these interventions work in ...