A Novel Computer-Based Therapy for Social Anxiety

New York State Psychiatric Institute

Status: Suspended

Conditions: Social Anxiety Disorder

Treatments: Behavioral: GC-MRT; Behavioral: modified GC-MRT; Behavioral: Non-GC-MRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03240003

7527 (SAD)

Details and patient eligibility

About

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)

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

GC-MRT

Experimental group

Description:

Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT

Treatment:

Behavioral: GC-MRT

non-GC-MRT

Active Comparator group

Description:

Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT

Treatment:

Behavioral: Non-GC-MRT

GC-MRT-modified

Experimental group

Description:

Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.

Treatment:

Behavioral: modified GC-MRT