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Clinical Trials/NCT04450303
NCT04450303CompletedNot Applicable

Social Anxiety Telehealth Therapy Study

Stanford University1 site in 1 country26 target enrollmentStarted: October 30, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
UCLA Loneliness Scale version 3

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Arms & Interventions

Telehealth Therapy

Experimental

Intervention: Telehealth CBT (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Liebowitz Social Anxiety Scale (LSAS)(24 weeks)
  • UCLA Loneliness Scale version 3(24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tali Manber Ball, PhD

Instructor

Stanford University

Study Sites (1)

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