Computer - Based Treatment for Social Anxiety Disorder

NCT04663724 | Suspended

• 2 other identifiers: 80725R33MH116089-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Social Anxiety Disorder

Keywords

Attention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Total Score of Social Phobia Inventory (SPIN)

  Baseline to Month 4

• Clinical Global Impression-Change Scale

  Baseline to Month 4

Study Arms (2)

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.

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.

Behavioral: Computer-Based Treatment

Interventions

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.

Comparator Computer-Based Treatment; Experimental Computer-Based Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator
• Mclean Hospital: collaborator
• Tel Aviv University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• FRANKLIN SCHNEIER, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Anxiety Disorders Clinic

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: February 15, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after completion of study assessments

Locations

US (1)