Social Anxiety Telehealth Therapy Study

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04450303
Collaborator
(none)
26
1
1
7.1
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telehealth CBT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Social Anxiety Telehealth Therapy Study
Actual Study Start Date :
Oct 30, 2020
Actual Primary Completion Date :
Jun 2, 2021
Actual Study Completion Date :
Jun 2, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Liebowitz Social Anxiety Scale (LSAS) [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) [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 [12 weeks]

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

    Secondary Outcome Measures

    1. Liebowitz Social Anxiety Scale (LSAS) [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 [24 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Tali Ball, PhD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tali Manber Ball, PhD, Instructor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT04450303
    Other Study ID Numbers:
    • 56697
    First Posted:
    Jun 29, 2020
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2021