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
Among 187 studies in Phobia, Social with a site in United States — 23 open to participants now, 29 under way, 1 of them phase 3. Phobia, Social · United States.
Among the 187 studies in Phobia, Social with a site in United States, this one is the 129th largest by enrollment of the 178 interventional ones that give a count, is one of 8 that started in 2018, is one of 100 with no phase, and was the 108th registered.
368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.
Browse Phobia, Social studies →23 of the 187 studies in Phobia, Social with a site in United States are open now. Recruiting first, the newest first:
Jason Careri · Sites in United States
Ages 18–65
Andrew Wiese · Sites in United States
Ages 7–17
Newleos Therapeutics, Inc. · Sites in United States
Ages 18–65
Bradley Hospital · Sites in United States
Ages 5–18
Ohio State University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 34 · Phase 3 21 · Phase 4 18
First in 1998; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 41 is below the median of 76 across 339 interventional studies indexed under Phobia, Social.
Median enrollment 64 across the 178 interventional studies, 184 across the 8 observational. Of the 146 that completed or were terminated, 59 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 187 have an industry lead sponsor. The 10 most frequent:
New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
New York State Psychiatric Institute has 6 studies filed under Phobia, Social — fewer than ten, so there is no comparison to draw.
13 of the studies in Phobia, Social with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221578Phase 3Vanda PharmaceuticalsStudy to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder | 2026-12 |
| NCT04663724New York State Psychiatric InstituteComputer - Based Treatment for Social Anxiety Disorder | 2026-11-30 |
| NCT07589621Florida State UniversitySafety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns | 2026-12 |
| NCT05467683Jasper A. SmitsCO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy | 2026-12-01 |
| NCT07028216Georgetown UniversityMindful Self-compassion for Anxiety and Depression: Impact of Delivery Method | 2026-12-17 |
Add all 13 to your calendar (.ics) → With an account.
Among the 187 studies in Phobia, Social with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Time frame: Raw data will be submitted semi-annually every January 15 and July 15.
Access criteria: see URL below for criteria
Data sharing details ↗ · nda.nih.gov
Ran from Jan 2018 to primary completion in Mar 2020, 26 months.
Results were first posted in Aug 2020, 4 months after primary completion.
Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 26 months is close to that.
Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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 →