A Novel Computer-Based Therapy for Social Anxiety

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Novel Computer-Based Therapy for Social Anxiety

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: GC-MRT
* Behavioral: modified GC-MRT
* Behavioral: Non-GC-MRT


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 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)

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC-MRT<br>Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT | Behavioral: GC-MRT<br>* Group 1 will receive a 4-week (8-sessions) course of GC-MRT<br>|
| Active Comparator: non-GC-MRT<br>Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT | Behavioral: Non-GC-MRT<br>* Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT<br>|
| Experimental: GC-MRT-modified<br>Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT. | Behavioral: modified GC-MRT<br>* group 3 will receive a 4-week (8-sessions) course of GC-MRT, modified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale | Total score of the Liebowitz Social Anxiety Scale | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Phobia Inventory (SPIN) | The Social Phobia Inventory (abbreviated as SPIN) is a self-rated questionnaire that will be 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). | 4 months | 
| 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. | 4 months | 
| 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). | 4 months | 
| Snaith Hamilton Pleasure Scale | Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated 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) | 4 months | 
| 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). | 4 months | 
| Clinical Global Impression-Change Scale | Clinical Global Impression-Change Scale: A quickly administered and widely used observer rating, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2. | 4 months | 

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