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NCT Number: NCT04663724

Computer - Based Treatment for Social Anxiety Disorder

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)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1051 Riverside Drive

New York, 10032, United States

Location status: Recruiting

Location contact

Bret R Rutherford, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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) for at least 3 months
  • Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months
  • Pregnancy, or plans to become pregnant during the period of the study (will be assessed by urine)
  • Contraindication to MRI scanning (Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body)
  • pacemaker
  • paramagnetic metallic prosthesis
  • surgical clips
  • shrapnel
  • necessity for constant medicinal patch
  • some tattoos
  • Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)

Treatment and study plan

Computer-Based Treatment

Behavioral

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.

Primary outcomes

  1. Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)

    Time frame: From baseline up to Month 4

    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.

  2. Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire

    Time frame: From baseline up to Month 4

    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.

Secondary outcomes

  1. Change in Total Score of Social Phobia Inventory (SPIN)

    Time frame: Baseline to Month 4

    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).

  2. Clinical Global Impression-Change Scale

    Time frame: Baseline to Month 4

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franklin Schneier, MD

CONTACT

[email protected]

6467748041

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University
  • Mclean Hospital
  • National Institute of Mental Health (NIMH)
  • Tel Aviv University

Registry information

Official study title

Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2020
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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