Computer-Based Treatment for Social Anxiety Disorder

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Novel Computer-Based Treatment for Social Anxiety: Target Engagement

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: computer-based treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Computer-based task involving free viewing of faces and listening to music
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-week computer-based treatment<br>A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. | Behavioral: computer-based treatment<br>* 30 minute sessions of free viewing of faces and listening to music<br>|
| Experimental: 8-week computer-based treatment<br>An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks. | Behavioral: computer-based treatment<br>* 30 minute sessions of free viewing of faces and listening to music<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Dwell Time on Threat Faces | Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline. | baseline to week 8 | 
| 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. | Baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Score of Social Phobia Inventory (SPIN) | The Social Phobia Inventory (SPIN) is a self-rated questionnaire 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). | baseline to week 8 | 
| 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. | baseline to week 8 | 
| Change in Total Score of the Revised Social Anhedonia Scale | 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) | baseline to week 8 | 
| Change in Total Score of the Snaith Hamilton Pleasure Scale | Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate 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) | baseline to week 8 | 
| Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version | 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). | baseline to week 8 | 
| Clinical Global Impression-Change Scale | Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2. | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAD, Social Anxiety, Social Phobia