Social Anxiety Telehealth Therapy Study

Social Anxiety Clinical Trial

Official title:

Social Anxiety Telehealth Therapy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450303
• Other study ID #: 56697
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

Behavioral:
• Telehealth CBT
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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	UCLA Loneliness Scale version 3	Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.	12 weeks
Secondary	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
Secondary	UCLA Loneliness Scale version 3	Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.	24 weeks