Computer - Based Treatment for Social Anxiety Disorder

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)

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Computer-Based Treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franklin Schneier, MD; Phone Number: 6467748041; Email: franklin.schneier@nyspi.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • 1051 Riverside Drive
      • Principal Investigator: Bret R Rutherford, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

  1. pacemaker
  2. paramagnetic metallic prosthesis
  3. surgical clips
  4. shrapnel
  5. necessity for constant medicinal patch
  6. some tattoos
• Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Computer-Based Treatment; A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.	Behavioral: Computer-Based Treatment; 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.
Active Comparator: Comparator Computer-Based Treatment; A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.	Behavioral: Computer-Based Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From baseline up to Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline to Month 4

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH); Columbia University; Tel Aviv University; Mclean Hospital
• Investigators: Principal Investigator: FRANKLIN SCHNEIER, MD, New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Attention
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: 8072; 5R33MH116089-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 12 months after completion of study assessments
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No