A Novel Computer-Based Therapy for Social Anxiety

Not Applicable

Suspended

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: GC-MRT; Behavioral: modified GC-MRT; Behavioral: Non-GC-MRT

• Registration Number: NCT03240003
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD)

Detailed Description

The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) 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 twice a week for 4 weeks, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using a scan called magnetic resonance imaging (MRI).

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-04
• Study Start: 2017-08-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females between the ages of 18 and 60
• Current DSM-V primary diagnosis of SAD
• Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
• Fluent in English and willing and able to give informed written consent and 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 PTSD, 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 allowed)
• Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
• Any concurrent cognitive behavioral therapy; 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 β-HCG
• Contraindication to MRI scanning:
• Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
• Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC-MRT	GC-MRT	Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT
GC-MRT-modified	modified GC-MRT	Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.
non-GC-MRT	Non-GC-MRT	Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT

Primary Outcome Measures

Name	Time	Method
Liebowitz Social Anxiety Scale	4 months	Total score of the Liebowitz Social Anxiety Scale

Secondary Outcome Measures

Name	Time	Method
Social Phobia Inventory (SPIN)	4 months	The Social Phobia Inventory (abbreviated as SPIN) is a self-rated questionnaire that will be 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).
Revised Social Anhedonia Scale	4 months	40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia).
Snaith Hamilton Pleasure Scale	4 months	Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Quality of Life Enjoyment & Satisfaction Questionnaire	4 months	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.
Clinical Global Impression-Change Scale	4 months	Clinical Global Impression-Change Scale: A quickly administered and widely used observer rating, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
Hamilton Rating Scale for Depression - 17 item version	4 months	Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States