Social Anxiety Telehealth Therapy Study

NCT04450303 | Completed

• 1 other identifier: 56697
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Liebowitz Social Anxiety Scale (LSAS)

  24 weeks

• UCLA Loneliness Scale version 3

  24 weeks

Study Arms (1)

Telehealth Therapy

EXPERIMENTAL

Behavioral: Telehealth CBT

Interventions

Telehealth CBT BEHAVIORAL

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.

Also known as: CALM

Telehealth Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Study Officials

• Tali Ball, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 29, 2020
• Study Start: October 30, 2020
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

US (1)