Computer - Based Treatment for Social Anxiety Disorder

Study Overview
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Brief Summary
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The present study is a controlled 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 forms of a recently developed 4-week/8-session 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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Computer-Based Treatment for Social Anxiety Disorder, A Randomized Controlled Trial

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 to 60 Current primary diagnosis of SAD Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version) Fluent in English Willing and able to give informed written consent Ability to 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 post-traumatic 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) Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for at least 3 months Any concurrent cognitive behavioral therapy or 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) pacemaker paramagnetic metallic prosthesis surgical clips shrapnel necessity for constant medicinal patch some tattoos Inability to tolerate MRI 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 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>* A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.<br>|
| Active Comparator: Comparator 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>* A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline up to Month 4 | 
| 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. | From baseline up to Month 4 | 

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 Month 4 | 
| 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. | Baseline to Month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention