Social Anxiety Telehealth Therapy Study
Primary Purpose
Social Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth CBT
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety
Eligibility Criteria
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telehealth Therapy
Arm Description
Outcomes
Primary Outcome Measures
Liebowitz Social Anxiety Scale (LSAS)
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
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.
UCLA Loneliness Scale version 3
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Secondary Outcome Measures
Liebowitz Social Anxiety Scale (LSAS)
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
UCLA Loneliness Scale version 3
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04450303
Brief Title
Social Anxiety Telehealth Therapy Study
Official Title
Social Anxiety Telehealth Therapy Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehealth Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Telehealth CBT
Other Intervention Name(s)
CALM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
Time Frame
12 weeks
Title
Satisfaction with Therapy and Therapists Scale (STTS)
Description
Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.
Time Frame
12 weeks
Title
UCLA Loneliness Scale version 3
Description
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
Time Frame
24 weeks
Title
UCLA Loneliness Scale version 3
Description
Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tali Ball, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Social Anxiety Telehealth Therapy Study
We'll reach out to this number within 24 hrs