Social Anxiety Telehealth Therapy Study

Study Overview
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Brief Summary
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The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes; while physical distancing is required to reduce infection risk, it also increases loneliness and isolation and prevents access to traditional in-person therapy, which further contribute to risk of adverse mental health outcomes. These problems may be especially acute for individuals with social anxiety disorder (as many as 12% of Americans), however there is a limited evidence-base for telehealth options to directly address social anxiety. This project aims to adapt exposure therapy for social anxiety to a telehealth and physical distancing-compatible intervention, and test whether this effectively decreases loneliness in adults with elevated social anxiety.

Official Title
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Social Anxiety Telehealth Therapy Study

Conditions
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Social Anxiety

Intervention / Treatment
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* Behavioral: Telehealth CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+, Liebowitz Social Anxiety Scale (LSAS) total score > 50 Fluent spoken and written English Access to the internet via a smartphone or computer with a camera Ability to provide informed consent. Exclusion Criteria: History of mania or psychosis Moderate or severe substance use disorder within the past year Current psychiatric diagnosis of greater impairment than that arising from social anxiety High risk for suicide (>8 on the Mini International Neuropsychiatric Interview suicidality section) Prior exposure therapy (more than 2 sessions) Current psychotropic medication use Current psychotherapy other than couples counseling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Therapy<br> | Behavioral: Telehealth CBT<br>* The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.<br>* Other names: CALM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale (LSAS) | Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144. | 12 weeks | 
| Satisfaction with Therapy and Therapists Scale (STTS) | Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30. | 12 weeks | 
| UCLA Loneliness Scale version 3 | Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale (LSAS) | Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144. | 24 weeks | 
| UCLA Loneliness Scale version 3 | Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80. | 24 weeks |