Social Anxiety Telehealth Therapy Study

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Behavioral: Telehealth CBT

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Telehealth Therapy

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.; Other Names: CALM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Tali Ball, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 56697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No