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Completed

NCT Number: NCT04450303

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.

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Key information

Conditions

Social Anxiety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: CALM

Primary outcomes

  1. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: 12 weeks

    Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

  2. Satisfaction with Therapy and Therapists Scale (STTS)

    Time frame: 12 weeks

    Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.

  3. UCLA Loneliness Scale version 3

    Time frame: 12 weeks

    Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Secondary outcomes

  1. Liebowitz Social Anxiety Scale (LSAS)

    Time frame: 24 weeks

    Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.

  2. UCLA Loneliness Scale version 3

    Time frame: 24 weeks

    Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2020
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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