Clinical trial NCT03240003: A Novel Computer-Based Therapy for Social Anxiety
Official title: A Novel Computer-Based Therapy for Social Anxiety
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety
Social Anxiety Disorder
SAD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: 4 months
Secondary outcomes:
measure: Social Phobia Inventory (SPIN)
timeFrame: 4 months
measure: Quality of Life Enjoyment & Satisfaction Questionnaire
timeFrame: 4 months
measure: Revised Social Anhedonia Scale
timeFrame: 4 months
measure: Snaith Hamilton Pleasure Scale
timeFrame: 4 months
measure: Hamilton Rating Scale for Depression - 17 item version
timeFrame: 4 months
measure: Clinical Global Impression-Change Scale
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI
name: Franklin Schneier, MD
role: PRINCIPAL_INVESTIGATOR
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