Trial Outcomes & Findings for Computer-Based Treatment for Social Anxiety Disorder (NCT NCT03415022)

Last Updated: 2022-04-04

Results Overview

Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

baseline to week 8

Results posted on

2022-04-04

Participant Flow

9 participants discontinued the study after initial evaluation but before treatment randomization: * 5 discontinued due to scheduling difficulties * 2 discontinued due to COVID-19 research suspension * 2 discontinued due to difficulties calibrating eye tracker used for treatment sessions

Participant milestones

Participant milestones
Measure	4-week Computer-based Treatment A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	8-week Computer-based Treatment An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
Overall Study STARTED	21	20
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	4-week Computer-based Treatment A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	8-week Computer-based Treatment An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
Overall Study Withdrawal by Subject	1	2
Overall Study COVID-19 Suspension	2	3
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Computer-Based Treatment for Social Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4-week Computer-based Treatment n=21 Participants A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	8-week Computer-based Treatment n=20 Participants An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks. computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	27.7 years STANDARD_DEVIATION 5.08 • n=5 Participants	29.15 years STANDARD_DEVIATION 7.13 • n=7 Participants	28.61 years STANDARD_DEVIATION 6.19 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
Liebowitz Social Anxiety Scale	83.8 units on a scale STANDARD_DEVIATION 16.81 • n=5 Participants	87.6 units on a scale STANDARD_DEVIATION 11.32 • n=7 Participants	86.05 units on a scale STANDARD_DEVIATION 14.28 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 8

Outcome measures

Outcome measures
Measure	4-week Computer-based Treatment n=16 Participants A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	8-week Computer-based Treatment n=15 Participants An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
Change in Percent Dwell Time on Threat Faces	20.7 percentage of dwell time on threat faces Standard Deviation 20.6	27.1 percentage of dwell time on threat faces Standard Deviation 17.6

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Participants who completed 8 weeks of study participation

Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.

Outcome measures

Outcome measures
Measure	4-week Computer-based Treatment n=16 Participants A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music	8-week Computer-based Treatment n=15 Participants An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)	23.68 score on a scale Standard Deviation 32.44	22.38 score on a scale Standard Deviation 22.87

SECONDARY outcome

Timeframe: baseline to week 8

Population: participants with 8 weeks of assessments

The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).