Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Study Overview
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Brief Summary
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The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.

Conditions
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Social Anxiety Disorder, Social Phobia

Intervention / Treatment
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* Behavioral: Exposure in vivo
* Behavioral: Virtual Reality Exposure Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years old a primary diagnosis of social anxiety disorder as measured with the SCID fluency in Dutch. Exclusion Criteria: psychotic episodes in the past, suicidal intentions or substance dependence. behavior therapy in the preceding one year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure in vivo<br>This treatment will consist of 10 sessions (twice a week) of exposure therapy based on the protocol used previously in exposure therapy for social anxiety disorder by Scholing & Emmelkamp (1993). | Behavioral: Exposure in vivo<br> <br> * Other names: Behavior Therapy;|
| Experimental: Virtual Reality Exposure Therapy<br>This treatment consists of 10 sessions (twice a week) of exposure therapy by using virtual environments. The difference between the exposure in vivo and virtual reality exposure therapy is the exposure component, which will be delivered in vivo in one condition and through the Head Mounted Display (HMD) in the other condition. | Behavioral: Virtual Reality Exposure Therapy<br> <br> * Other names: Virtual Reality Therapy;|
| No Intervention: Wait-list<br>Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline: Liebowitz Social Anxiety Scale-Self report | Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up. | Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. | 
| Change from baseline: Fear of Negative Evaluation Scale | Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up. | Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale | The BAT consists of a videotaped 5 minute impromptu speech in front of two confederates. The Public Speaking Performance Scale will be used to evaluate the performance during the speech, both by patients and indipendent raters. Change from pre-treatment to post-treatment (5 weeks) will be examined. | Pre-treatment to post-treatment (5 weeks) | 
| Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module) | Change in diagnosis of Social Phobia from pre-treatment to three months follow-up. | Pre-treatment to three months follow-up. | 
| Change from baseline: Depression Anxiety Stress Scale | Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up. | Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. | 
| Change from baseline: Personality Disorder Belief Questionnaire | Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up. | Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. | 
| Change from baseline: Eurohis Quality of Life Scale | Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up. | Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure