Clinical trial NCT03415022: Computer-Based Treatment for Social Anxiety Disorder
Official title: A Novel Computer-Based Treatment for Social Anxiety: Target Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: SAD
Social Anxiety
Social Phobia
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Computer-based task involving free viewing of faces and listening to music
Primary purpose: TREATMENT

Brief summary: The present study is an open 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 "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed 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).

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 18 and 60
* Current 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 posttraumatic 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 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
* 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: Change in Percent Dwell Time on Threat Faces
timeFrame: baseline to week 8
measure: Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Baseline to week 8
Secondary outcomes:
measure: Change in Total Score of Social Phobia Inventory (SPIN)
timeFrame: baseline to week 8
measure: Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
timeFrame: baseline to week 8
measure: Change in Total Score of the Revised Social Anhedonia Scale
timeFrame: baseline to week 8
measure: Change in Total Score of the Snaith Hamilton Pleasure Scale
timeFrame: baseline to week 8
measure: Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version
timeFrame: baseline to week 8
measure: Clinical Global Impression-Change Scale
timeFrame: week 8
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Franklin Schneier, MD
role: PRINCIPAL_INVESTIGATOR
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