An interventional study of computer-based treatment in Social Anxiety Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
The present study is an open trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).
Exclusion Criteria:
A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Behavioral: 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.
Behavioral: computer-based treatment
30 minute sessions of free viewing of faces and listening to music
Change in Percent Dwell Time on Threat Faces
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.
Time frame: baseline to week 8
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
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.
Time frame: Baseline to week 8
Change in Total Score of Social Phobia Inventory (SPIN)
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).
Time frame: baseline to week 8
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
Quality of Life Enjoyment \& Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Time frame: baseline to week 8
Change in Total Score of the Revised Social Anhedonia Scale
40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia)
Time frame: baseline to week 8
Change in Total Score of the Snaith Hamilton Pleasure Scale
Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Time frame: baseline to week 8
Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version
Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
Time frame: baseline to week 8
Clinical Global Impression-Change Scale
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
Time frame: week 8
| Milestone | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Started | 21 | 20 |
| Completed | 16 | 15 |
| Not completed | 5 | 5 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Covid-19 suspension | 2 | 3 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| percentage of dwell time on threat faces | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Percent Dwell Time on Threat Faces | 20.7 ± 20.6 | 27.1 ± 17.6 |
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.
| score on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | 23.68 ± 32.44 | 22.38 ± 22.87 |
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).
| score on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of Social Phobia Inventory (SPIN) | 17.7 ± 18.5 | 10.1 ± 13.5 |
Quality of Life Enjoyment \& Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
| score on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | -8.8 ± 15.3 | -4.8 ± 12.4 |
40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia)
| units on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of the Revised Social Anhedonia Scale | 1.7 ± 5.6 | 1.8 ± 4.9 |
Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
| units on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of the Snaith Hamilton Pleasure Scale | 2.2 ± 6.2 | -1.0 ± 5.8 |
Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
| units on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version | 1.8 ± 4.4 | 1.8 ± 5.8 |
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
| units on a scale | 4-week Computer-based Treatment | 8-week Computer-based Treatment |
|---|---|---|
| Clinical Global Impression-Change Scale | 2.8 ± 1.2 | 2.7 ± 0.9 |
Collected over 20 weeks (8 weeks of active treatment phase and 3 month follow-up phase). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4-week Computer-based Treatment | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| 8-week Computer-based Treatment | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Participants who started treatment sessions
| Age, Categorical(Participants) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 20 | 41 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| Mean | 27.7 ± 5.08 | 29.15 ± 7.13 | 28.61 ± 6.19 |
| Sex: Female, Male(Participants) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| Female | 12 | 13 | 25 |
| Male | 9 | 7 | 16 |
| Race (NIH/OMB)(Participants) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 6 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 10 | 6 | 16 |
| More than one race | 5 | 2 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| United States | 21 | 20 | 41 |
| Liebowitz Social Anxiety Scale(units on a scale) | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| Mean | 83.8 ± 16.81 | 87.6 ± 11.32 | 86.05 ± 14.28 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be shared through the National Database for Clinical Trials related to Mental Illness (NDCT). We will generate a Global Unique Identifier (GUID) for each participant. The key clinical rating scale measures (LSAS, SPIN, QLESQ, HRSD) are all included.
Supporting information: Analytic code
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute