ClinicalTrials.gg
CompletedNCT04450303Updated Sep 23, 2021

Social Anxiety Telehealth Therapy Study

An interventional study of Telehealth CBT in Social Anxiety, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Social Anxiety
03

In context

Lead sponsor

Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Telehealth Therapy

    Behavioral: Telehealth CBT

Interventions

  • BehavioralTelehealth 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.

    Also known as: CALM

06

What researchers measure

Primary outcomes

  1. Liebowitz Social Anxiety Scale (LSAS)

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

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. UCLA Loneliness Scale version 3

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

    Time frame: 12 weeks

Secondary outcomes

  1. Liebowitz Social Anxiety Scale (LSAS)

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

    Time frame: 24 weeks

  2. UCLA Loneliness Scale version 3

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

    Time frame: 24 weeks

07

Study locations

1 site
  • Stanford University
    Stanford, California 94304, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04450303
Responsible party
Tali Manber Ball, PhD (Instructor, Stanford University) — Principal investigator
First posted
Jun 29, 2020
Start date
Oct 30, 2020
Primary completion
Jun 2, 2021
Completion
Jun 2, 2021
Last update
Sep 23, 2021

Study contacts

Tali Ball, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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