NCT04729803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

December 7, 2020

Results QC Date

December 6, 2022

Last Update Submit

January 5, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Personal Report of Communication Apprehension Questionnaire

    Assessment of communication concerns, range of scores is 24-120; higher scores are worse

    prior to the first treatment session, an average of 2 days

  • Personal Report of Communication Apprehension Questionnaire

    Assessment of communication concerns, range of scores is 24-120; higher scores are worse

    1-week follow-up

  • Personal Report of Communication Apprehension Questionnaire

    Assessment of communication concerns, range of scores is 24-120; higher scores are worse

    2-week follow-up

  • Leibowitz Social Anxiety Scale Questionnaire

    Assessment of general social anxiety, range of scores is 0-144; higher scores are worse

    prior to the first treatment session, an average of 2 days

  • Leibowitz Social Anxiety Scale Questionnaire

    Assessment of general social anxiety, range of scores is 0-144; higher scores are worse

    1-week follow-up

  • Leibowitz Social Anxiety Scale Questionnaire

    Assessment of general social anxiety, range of scores is 0-144; higher scores are worse

    2-week follow-up

Study Arms (3)

Attention Guidance + Exposure

EXPERIMENTAL

Participants will complete teleconferencing-based exposure trials with an attention guidance component.

Behavioral: Experimental: Attention Guidance + Exposure

Exposure Alone

ACTIVE COMPARATOR

Participants will complete teleconferencing-based exposure trials.

Behavioral: Active Comparator: Exposure Alone

Attention Control + Exposure

EXPERIMENTAL

Participants will complete teleconferencing-based exposure trials with an attention control component.

Behavioral: Experimental: Attention Control + Exposure

Interventions

1. Participants will receive a brief standardized psychoeducation module, presented via a video recording. 2. Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. 3. Between speeches participants will have a 1-minute break. 4. 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.

Attention Guidance + Exposure

1. Participants will receive a brief standardized psychoeducation module, presented via a video recording. 2. Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. 3. Between speeches participants will have a 1-minute break. 4. Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.

Exposure Alone

1. Participants will receive a brief standardized psychoeducation module, presented via a video recording. F 2. 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. 3. Between speeches participants will have a 1-minute break. 4. 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.

Attention Control + Exposure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant visual impairment precluding the use of the eye tracking equipment
  • Current, or history of bipolar disorder; current, or history of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Results Point of Contact

Title
Dr. Mikael Rubin
Organization
palo alto university

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

January 29, 2021

Study Start

January 18, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Anonymized data and analysis syntax will be made available using an open data repository (e.g. osf.io)

Shared Documents
SAP, ANALYTIC CODE

Locations