Attention, Teleconferencing and Social Anxiety
Primary Purpose
Social Anxiety Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Attention Guidance + Exposure
Active Comparator: Exposure Alone
Experimental: Attention Control + Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18-75
- Fluent in English because the data collection materials have not yet been standardized in other languages
- Having access to a computer with a webcam and ability to record audio
- Personal Report of Communication Apprehension > 80
- Leibowitz Social Anxiety Scale > 30
- Meets DSM-5 Criteria for Social Anxiety Disorder
Exclusion Criteria:
- Significant visual impairment precluding the use of the eye tracking equipment
- Current, or history of bipolar disorder; current, or history of psychosis
Sites / Locations
- Laboratory for the Study of Anxiety Disorders, University of Texas at AustinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Attention Guidance + Exposure
Exposure Alone
Attention Control + Exposure
Arm Description
Participants will complete teleconferencing-based exposure trials with an attention guidance component.
Participants will complete teleconferencing-based exposure trials.
Participants will complete teleconferencing-based exposure trials with an attention control component.
Outcomes
Primary Outcome Measures
Personal Report of Communication Apprehension Questionnaire
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Personal Report of Communication Apprehension Questionnaire
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Personal Report of Communication Apprehension Questionnaire
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Personal Report of Communication Apprehension Questionnaire
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Leibowitz Social Anxiety Scale Questionnaire
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Leibowitz Social Anxiety Scale Questionnaire
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Leibowitz Social Anxiety Scale Questionnaire
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Leibowitz Social Anxiety Scale Questionnaire
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Secondary Outcome Measures
Full Information
NCT ID
NCT04729803
First Posted
December 7, 2020
Last Updated
August 19, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04729803
Brief Title
Attention, Teleconferencing and Social Anxiety
Official Title
Investigating Attentional Processes: Teleconferencing and Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
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
This study involves completing some online assessments and an intervention for social anxiety that all involve interactions with other people on a teleconferencing call.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Attention Guidance + Exposure
Arm Type
Experimental
Arm Description
Participants will complete teleconferencing-based exposure trials with an attention guidance component.
Arm Title
Exposure Alone
Arm Type
Active Comparator
Arm Description
Participants will complete teleconferencing-based exposure trials.
Arm Title
Attention Control + Exposure
Arm Type
Experimental
Arm Description
Participants will complete teleconferencing-based exposure trials with an attention control component.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Attention Guidance + Exposure
Intervention Description
Participants will receive a brief standardized psychoeducation module, presented via a video recording.
Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
The experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.
Intervention Type
Behavioral
Intervention Name(s)
Active Comparator: Exposure Alone
Intervention Description
Participants will receive a brief standardized psychoeducation module, presented via a video recording.
Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Attention Control + Exposure
Intervention Description
Participants will receive a brief standardized psychoeducation module, presented via a video recording.
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Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.
Between speeches participants will have a 1-minute break.
Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
The experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.
Primary Outcome Measure Information:
Title
Personal Report of Communication Apprehension Questionnaire
Description
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Time Frame
prior to the first treatment session, an average of 2 days
Title
Personal Report of Communication Apprehension Questionnaire
Description
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Time Frame
through study completion, an average of 2 weeks
Title
Personal Report of Communication Apprehension Questionnaire
Description
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Time Frame
1-week follow-up
Title
Personal Report of Communication Apprehension Questionnaire
Description
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Time Frame
2-week follow-up
Title
Leibowitz Social Anxiety Scale Questionnaire
Description
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Time Frame
prior to the first treatment session, an average of 2 days
Title
Leibowitz Social Anxiety Scale Questionnaire
Description
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Time Frame
through study completion, an average of 2 weeks
Title
Leibowitz Social Anxiety Scale Questionnaire
Description
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Time Frame
1-week follow-up
Title
Leibowitz Social Anxiety Scale Questionnaire
Description
Assessment of general social anxiety, range of scores is 0-144; higher scores are worse
Time Frame
2-week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75
Fluent in English because the data collection materials have not yet been standardized in other languages
Having access to a computer with a webcam and ability to record audio
Personal Report of Communication Apprehension > 80
Leibowitz Social Anxiety Scale > 30
Meets DSM-5 Criteria for Social Anxiety Disorder
Exclusion Criteria:
Significant visual impairment precluding the use of the eye tracking equipment
Current, or history of bipolar disorder; current, or history of psychosis
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Rubin, MA
Phone
646-685-4681
Email
mikaelrubin@utexas.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data and analysis syntax will be made available using an open data repository (e.g. osf.io)
Learn more about this trial
Attention, Teleconferencing and Social Anxiety
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