Computer - Based Treatment for Social Anxiety Disorder

Not Applicable

Suspended

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Computer-Based Treatment

• Registration Number: NCT04663724
• Lead Sponsor: New York State Psychiatric Institute

Brief 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)

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 Timeline

• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Study Start: 2021-02-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04
• Primary Completion: 2026-11-30
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Computer-Based Treatment	Computer-Based Treatment	A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
Comparator Computer-Based Treatment	Computer-Based Treatment	A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.

Primary Outcome Measures

Name	Time	Method
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)	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.
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire	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 Outcome Measures

Name	Time	Method
Change in Total Score of Social Phobia Inventory (SPIN)	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).
Clinical Global Impression-Change Scale	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.

Trial Locations

Locations (1)

1051 Riverside Drive; 🇺🇸 New York, New York, United States