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This study involves completing some online assessments and an intervention for social anxiety that all involve interactions with other people on a teleconferencing call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Guidance + Exposure | Experimental | Participants will complete teleconferencing-based exposure trials with an attention guidance component. |
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| Exposure Alone | Active Comparator | Participants will complete teleconferencing-based exposure trials. |
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| Attention Control + Exposure | Experimental | Participants will complete teleconferencing-based exposure trials with an attention control component. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Attention Guidance + Exposure | Behavioral |
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for the Study of Anxiety Disorders, University of Texas at Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39625833 | Derived | Rubin M, Gebhardt E, Malloy L, Telch MJ. An initial test of a new self-guided internet-based intervention for social anxiety: iExposure. Cogn Behav Ther. 2025 Jan;54(1):1-16. doi: 10.1080/16506073.2024.2368519. Epub 2024 Jun 19. |
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Anonymized data and analysis syntax will be made available using an open data repository (e.g. osf.io)
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Guidance + Exposure | Participants will complete teleconferencing-based exposure trials with an attention guidance component. Experimental: 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. 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. |
| FG001 | Exposure Alone | Participants will complete teleconferencing-based exposure trials. Active Comparator: Exposure Alone: 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. |
| FG002 | Attention Control + Exposure | Participants will complete teleconferencing-based exposure trials with an attention control component. Experimental: Attention Control + Exposure: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Guidance + Exposure | Participants will complete teleconferencing-based exposure trials with an attention guidance component. Experimental: 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Personal Report of Communication Apprehension Questionnaire | Assessment of communication concerns, range of scores is 24-120; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | prior to the first treatment session, an average of 2 days |
|
four weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exposure Alone | Participants will complete teleconferencing-based exposure trials. Active Comparator: Exposure Alone: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mikael Rubin | palo alto university | 650-433-3805 | mrubin@paloaltou.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2020 | Jan 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2022 | Dec 5, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2020 | Jan 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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|
| Active Comparator: Exposure Alone | Behavioral |
|
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| Experimental: Attention Control + Exposure | Behavioral |
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. |
|
| BG001 | Exposure Alone | Participants will complete teleconferencing-based exposure trials. Active Comparator: Exposure Alone: 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. |
| BG002 | Attention Control + Exposure | Participants will complete teleconferencing-based exposure trials with an attention control component. Experimental: Attention Control + Exposure: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Attention Control + Exposure |
Participants will complete teleconferencing-based exposure trials with an attention control component. Experimental: Attention Control + Exposure: 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. |
| OG002 | Attention Guidance + Exposure | Participants will complete teleconferencing-based exposure trials with an attention guidance component. Experimental: 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. 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. |
|
|
| Primary | Personal Report of Communication Apprehension Questionnaire | Assessment of communication concerns, range of scores is 24-120; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | 1-week follow-up |
|
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| Primary | Personal Report of Communication Apprehension Questionnaire | Assessment of communication concerns, range of scores is 24-120; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | 2-week follow-up |
|
|
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| Primary | Leibowitz Social Anxiety Scale Questionnaire | Assessment of general social anxiety, range of scores is 0-144; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | prior to the first treatment session, an average of 2 days |
|
|
|
| Primary | Leibowitz Social Anxiety Scale Questionnaire | Assessment of general social anxiety, range of scores is 0-144; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | 1-week follow-up |
|
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| Primary | Leibowitz Social Anxiety Scale Questionnaire | Assessment of general social anxiety, range of scores is 0-144; higher scores are worse | Posted | Mean | Standard Deviation | score on a scale | 2-week follow-up |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Attention Control + Exposure | Participants will complete teleconferencing-based exposure trials with an attention control component. Experimental: Attention Control + Exposure: 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. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Attention Guidance + Exposure | Participants will complete teleconferencing-based exposure trials with an attention guidance component. Experimental: 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. 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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