iExposure for Social Anxiety
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Palo Alto University
Must not be taking: Psychotropics
Disqualifiers: CBT, Visual impairment, Substance use, others
No Placebo Group
Trial Summary
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).
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.
12345Is 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.
14678What 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.
256910Eligibility 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
I am 18 years old or older.
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.
+2 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: iExposure + Attention Guidance AugmentationExperimental Treatment1 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 AugmentationExperimental Treatment1 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 iExposureActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Palo Alto UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Palo Alto UniversityLead Sponsor
References
Effectiveness randomized controlled trial of face to face versus Internet cognitive behaviour therapy for social phobia. [2022]To compare the effectiveness of Internet cognitive behaviour therapy (CBT) with face-to-face CBT in social phobia.
An Internet-based self-help treatment for fear of public speaking: a controlled trial. [2019]This study offers data about the efficacy of "Talk to Me," an Internet-based telepsychology program for the treatment of fear of public speaking that includes the most active components in cognitive-behavior therapy (CBT) for social phobia (exposure and cognitive therapies). One hundred twenty-seven participants with social phobia were randomly assigned to three experimental conditions: (a) an Internet-based self-administered program; (b) the same program applied by a therapist; (c) a waiting-list control group. Results showed that both treatment conditions were equally efficacious. In addition, Talk to Me and the same treatment applied by a therapist were more efficacious than the waiting-list condition. Treatment gains were maintained at 1-year follow-up. The results from this study support the utility of Internet-delivered CBT programs in order to reach a higher number of people who could benefit from CBT. Internet-delivered CBT programs could also play a valuable role in the dissemination of CBT.
Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help. [2022]Internet-based self-help for social phobia with minimal therapist support via email have shown efficacy in several controlled trials by independent research teams. The role and necessity of therapist guidance is, however, still largely unclear. The present study compared the benefits of a 10-week web-based unguided self-help treatment for social phobia with the same intervention complemented with minimal, although weekly, therapist support via email. Further, a third treatment arm was included, in which the level of support was flexibly stepped up, from no support to email or telephone contact, on demand of the participants. Eighty-one individuals meeting diagnostic criteria for social phobia were randomly assigned to one of the three conditions. Primary outcome measures were self-report measures of symptoms of social phobia. Secondary outcome measures included symptoms of depression, interpersonal problems, and general symptomatology. Measures were taken at baseline, post-treatment, and at 6-month follow-up. Data from a telephone-administered diagnostic interview conducted at post-treatment were also included. Results showed significant symptom reductions in all three treatment groups with large effect sizes for primary social phobia measures (Cohen's d=1.47) and for secondary outcome measures (d=1.16). No substantial and significant between-groups effects were found on any of the measures (Cohen's d=00-.36). Moreover, no difference between the three conditions was found regarding diagnosis-free status, clinically significant change, dropout rates, or adherence measures such as lessons or exercises completed. These findings indicate that Internet-delivered treatment for social phobia is a promising treatment option, whether no support is provided or with two different types of therapist guidance.
Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. [2022]Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail. Results were analyzed on an intention-to-treat basis, including all randomized participants. From pre- to posttest, treated participants in contrast to controls showed significant improvement on most measured dimensions (social anxiety scales, general anxiety and depression levels, quality of life). The overall within- and between-groups effect sizes were Cohen's d = 0.87 and 0.70, respectively. Treatment gains were maintained at 1-year follow-up. The results from this study support the continued use and development of Internet-distributed, self-help programs for people diagnosed with social phobia.
Acceptance based behavior therapy for social anxiety disorder through videoconferencing. [2019]Most individuals with social anxiety disorder (SAD) do not receive any type of treatment. Reasons include logistical barriers (e.g., geographic location, travel time), fear of stigmatization, and fear of the social interactions associated with seeking treatment. Videoconferencing technology holds great promise in the widespread delivery of evidence-based treatments to those who would otherwise not receive treatment. This pilot study assessed the feasibility, acceptability, and initial efficacy of an acceptance-based behavioral intervention using Skype videoconferencing to treat adults with generalized SAD. Twenty-four participants received 12 sessions of weekly therapy and were assessed at pre-treatment, mid-treatment, post-treatment, and 3-month follow-up. Participants and therapists rated the intervention as acceptable and feasible. Analyses revealed significant pre-treatment to follow-up improvements in social anxiety, depression, disability, quality of life, and experiential avoidance, with effect sizes comparable to or larger than previously published results of studies delivering in-person CBT for SAD. Implications and future directions are discussed.
A novel procedure to investigate social anxiety using videoconferencing software: A proof-of-concept study. [2022]Social anxiety disorder (SAD) is very common and can be significantly disabling. New treatments are needed as the remission rate for SAD is the lowest of all the anxiety disorders. Experimental medicine models, in which features resembling a clinical disorder are experimentally induced, are a cost-effective and timely approach to explore potential novel treatments for psychiatric disorders. Following the emergence of SARS-CoV-2, there is a need to develop experimental medicine models that can be carried out remotely. We developed a novel procedure to investigate SAD (the InterneT-based Stress test for Social Anxiety Disorder; ITSSAD) that can be carried out entirely online by a single investigator, potentially reducing costs and maximising internal reliability. The procedure involves an anticipatory period followed by a naturalistic social interaction task. In a sample of 20 non-treatment-seeking volunteers with symptoms of SAD, the ITSSAD induced significant subjective anxiety and reduced positive affect. Further, increased social anxiety symptoms at baseline predicted increased anxiety during the social interaction task. This protocol needs further validation with physiological measures. The ITSSAD is a new tool for researchers to investigate mechanisms underlying social anxiety disorder.
Development and validation of measures of social phobia scrutiny fear and social interaction anxiety. [2022]The development and validation of the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS) two companion measures for assessing social phobia fears is described. The SPS assesses fear of being scrutinised during routine activities (eating, drinking, writing, etc.), while the SIAS assesses fear of more general social interaction, the scales corresponding to the DSM-III-R descriptions of Social Phobia--Circumscribed and Generalised types, respectively. Both scales were shown to possess high levels of internal consistency and test-retest reliability. They discriminated between social phobia, agoraphobia and simple phobia samples, and between social phobia and normal samples. The scales correlated well with established measures of social anxiety, but were found to have low or non-significant (partial) correlations with established measures of depression, state and trait anxiety, locus of control, and social desirability. The scales were found to change with treatment and to remain stable in the face of no-treatment. It appears that these scales are valid, useful, and easily scored measures for clinical and research applications, and that they represent an improvement over existing measures of social phobia.
Pharmacotherapy for social anxiety disorder: a systematic review. [2018]Social anxiety disorder (SAD) is a prevalent, disabling disorder. We aimed to assess the effects of pharmacotherapy for SAD and to determine whether particular classes of medication are more effective and/or better tolerated than others. A systematic review and meta-analysis was conducted of all published and unpublished placebo-controlled randomized controlled trials (RCTs) undertaken between 1966 and 2007. A rigorous search, which included searching the Cochrane CCDANTR, MEDLINE and PsycINFO electronic databases, yielded a total of 51 RCTs (9914 participants) considered eligible for inclusion in the review. On average, over half of trial participants responded to medication, as assessed with the improvement item of the Clinical Global Impressions scale (55.2%), with approximately four participants having to be treated for an average of 12 weeks before an additional person responded to medication, relative to placebo (number needed to benefit = 4.19). There was substantial variation across medication classes in the number of dropouts due to adverse events, with an average number needed to harm of 14.4. Maintenance and relapse prevention studies confirm the value of longer-term medication in treatment responders. Medication was also effective in reducing SAD symptoms, comorbid depressive symptoms and associated disability. However, evidence for the efficacy of beta-blockers in treating performance anxiety was lacking. Taken together, trials of selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors provide the largest evidence base for agents that are both effective and well tolerated. This review is an updated version of a Cochrane Review in The Cochrane Library, Issue 4, 2004. Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and The Cochrane Library should be consulted for the most recent version of the review.
Videoconference anxiety: Conceptualization, scale development, and preliminary validation. [2022]As a result of the COVID-19 pandemic, activities involving a large part of life have started to be carried out via videoconferencing. Videoconferencing can be disadvantageous for individuals with social anxiety due to increased social presence, decreased mutual understanding, and awkward communication. The authors aimed to develop a scale to explore the difficulties experienced by individuals with social anxiety during videoconferencing. A total of 598 children and adolescents participated in the study. The data were collected with the Sociodemographic Information Form, the Videoconference Anxiety Scale, and the Liebowitz Social Anxiety Scale. According to exploratory factor analysis, the scale consisted of 25 items and a single factor. Factor loads were between 0.62 and 0.81; the single factor explained 52.95% of the variance. This study shows that the Videoconference Anxiety Scale is a valid and reliable instrument for Turkish children.
The Medium is the Message: Effects of Mediums of Communication on Perceptions and Emotions in Social Anxiety Disorder. [2021]We examined the use of voice/text and visual mediums and their effects on perceptions and emotions in social anxiety disorder (SAD). Our sample included 88 individuals: 44 individuals with SAD and 44 non-socially-anxious (NSA) individuals. We used an experience sampling methodology (ESM) in which participants received daily links to online measures at random times during the day, for 21 days and reported on social interactions, emotions and perceptions. Results indicated that individuals with SAD used voice/text mediums to a greater extent and used visual mediums to a lesser extent compared to NSA individuals. However, despite preferring voice/text mediums, use of visual mediums resulted in immediate increases in positive perceptions and emotions for individuals with SAD. These findings were above and beyond the effect of depressive symptoms and remained when social anxiety was represented as a continuum of severity. This has important implications for exposure interventions in the treatment of SAD.