Trial Outcomes & Findings for Attention, Teleconferencing and Social Anxiety (NCT NCT04729803)
NCT ID: NCT04729803
Last Updated: 2024-01-08
Results Overview
Assessment of communication concerns, range of scores is 24-120; higher scores are worse
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
prior to the first treatment session, an average of 2 days
Results posted on
2024-01-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
18
|
22
|
|
Overall Study
Post-treatment
|
7
|
15
|
12
|
|
Overall Study
COMPLETED
|
6
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Attention, Teleconferencing and Social Anxiety
Baseline characteristics by cohort
| Measure |
Attention Guidance + Exposure
n=13 Participants
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.
|
Exposure Alone
n=18 Participants
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.
|
Attention Control + Exposure
n=22 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.20 years
STANDARD_DEVIATION 1.52 • n=5 Participants
|
18.70 years
STANDARD_DEVIATION 1.02 • n=7 Participants
|
19.5 years
STANDARD_DEVIATION 1.77 • n=5 Participants
|
19.13 years
STANDARD_DEVIATION 1.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
18 participants
n=7 Participants
|
22 participants
n=5 Participants
|
53 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: prior to the first treatment session, an average of 2 daysAssessment of communication concerns, range of scores is 24-120; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=18 Participants
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.
|
Attention Control + Exposure
n=22 Participants
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.
|
Attention Guidance + Exposure
n=13 Participants
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.
|
|---|---|---|---|
|
Personal Report of Communication Apprehension Questionnaire
|
88.06 score on a scale
Standard Deviation 11.66
|
87.64 score on a scale
Standard Deviation 11.91
|
95.69 score on a scale
Standard Deviation 14.35
|
PRIMARY outcome
Timeframe: 1-week follow-upAssessment of communication concerns, range of scores is 24-120; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=15 Participants
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.
|
Attention Control + Exposure
n=12 Participants
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.
|
Attention Guidance + Exposure
n=7 Participants
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.
|
|---|---|---|---|
|
Personal Report of Communication Apprehension Questionnaire
|
70.71 score on a scale
Standard Deviation 7.01
|
65.90 score on a scale
Standard Deviation 5.36
|
70.00 score on a scale
Standard Deviation 1.10
|
PRIMARY outcome
Timeframe: 2-week follow-upAssessment of communication concerns, range of scores is 24-120; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=12 Participants
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.
|
Attention Control + Exposure
n=9 Participants
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.
|
Attention Guidance + Exposure
n=6 Participants
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.
|
|---|---|---|---|
|
Personal Report of Communication Apprehension Questionnaire
|
70.25 score on a scale
Standard Deviation 6.25
|
67.13 score on a scale
Standard Deviation 3.23
|
71.00 score on a scale
Standard Deviation 1.67
|
PRIMARY outcome
Timeframe: prior to the first treatment session, an average of 2 daysAssessment of general social anxiety, range of scores is 0-144; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=18 Participants
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.
|
Attention Control + Exposure
n=22 Participants
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.
|
Attention Guidance + Exposure
n=13 Participants
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.
|
|---|---|---|---|
|
Leibowitz Social Anxiety Scale Questionnaire
|
81.06 score on a scale
Standard Deviation 13.40
|
74.50 score on a scale
Standard Deviation 13.94
|
87.77 score on a scale
Standard Deviation 19.93
|
PRIMARY outcome
Timeframe: 1-week follow-upAssessment of general social anxiety, range of scores is 0-144; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=15 Participants
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.
|
Attention Control + Exposure
n=12 Participants
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.
|
Attention Guidance + Exposure
n=7 Participants
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.
|
|---|---|---|---|
|
Leibowitz Social Anxiety Scale Questionnaire
|
77.99 score on a scale
Standard Deviation 23.60
|
57.70 score on a scale
Standard Deviation 19.24
|
71.00 score on a scale
Standard Deviation 26.00
|
PRIMARY outcome
Timeframe: 2-week follow-upAssessment of general social anxiety, range of scores is 0-144; higher scores are worse
Outcome measures
| Measure |
Exposure Alone
n=12 Participants
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.
|
Attention Control + Exposure
n=9 Participants
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.
|
Attention Guidance + Exposure
n=6 Participants
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.
|
|---|---|---|---|
|
Leibowitz Social Anxiety Scale Questionnaire
|
81.67 score on a scale
Standard Deviation 23.52
|
50.13 score on a scale
Standard Deviation 15.72
|
71.00 score on a scale
Standard Deviation 30.91
|
Adverse Events
Exposure Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control + Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Guidance + Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place