Computer - Based Treatment for Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04663724
• Other study ID #: 8072
• Secondary ID: 5R33MH116089-04
• Status: Suspended
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	1051 Riverside Drive	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University, Mclean Hospital, National Institute of Mental Health (NIMH), Tel Aviv University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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