Social Anxiety DisorderNCT04663724
Computer - Based Treatment for Social Anxiety Disorder
A study testing Computer-Based Treatment in people with Social Anxiety Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The present study is a controlled 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) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Computer-Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between the ages of 18 to 60
- Current primary diagnosis of SAD
- Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version)
- Fluent in English
- Willing and able to give informed written consent
- Ability to participate responsibly in the protocol
- Normal or corrected-to-normal vision
Who cannot join
- Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
- Current severe depression
- Suicidal ideation or behavior
- Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
- Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
- Current unstable or untreated medical illness
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- Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders)
- Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), buspirone, or zolpidem for sleep for at least 3 months
- Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months
- Contraindication to MRI scanning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
1051 Riverside Drive
New York, New York, 10032
Franklin R Schneier, M.D.
About this study
Official title: Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial
The present study is a controlled 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)
Read the detailed description
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two forms of a recently developed 4-week/8-session 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).
- Conditions
- Social Anxiety Disorder
- Being tested
- Computer-Based Treatment
- Keywords
- Attention
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Based TreatmentBehavioural
A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Computer-Based Treatment | Experimental | A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Receives: Behavioral: Computer-Based Treatment |
| Comparator Computer-Based Treatment | Active comparator | A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. Receives: Behavioral: Computer-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline up to Month 4
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.
Measured: From baseline up to Month 4
Secondary outcomes (2)
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).
Measured: Baseline to Month 4
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.
Measured: Baseline to Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start15 Feb 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Mclean Hospital, Tel Aviv University, National Institute of Mental Health (NIMH), University of Texas
- Responsible party
- Principal investigator, Franklin Schneier, New York State Psychiatric Institute
- Investigators
- FRANKLIN SCHNEIER, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663724
- Sponsor's protocol ID
- 8072
- Other IDs
- 5R33MH116089-04
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the National Database for Clinical Trials related to Mental Illness (NDCT). We will obtain information needed to generate a Global Unique Identifier (GUID) for each participant (sex, first name, last name, middle name, date of birth, and city/municipality of birth). Raw data will be submitted semi-annually every January 15 and July 15, and prior to the end of each grant.