Virtual Reality Immersive Method for Spider (Phobia) Exposure Therapy (VIMSE)

Study Overview
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Brief Summary
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The aim of this study is to examine the efficacy of virtual reality exposure therapy as a treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a non-inferiority margin of a 2-point difference between groups.

Official Title
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Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial

Conditions
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Phobia, Specific

Intervention / Treatment
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* Other: OST treatment with in-vivo spiders
* Other: VR-OST treatment with virtual spiders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score of 10 or less in Behavioral Approach Test Individual meeting DSM-5 criteria according to interview for primary diagnosis of specific phobia, spider Swedish residency Fluent in Swedish Exclusion Criteria: Ongoing psychotherapy Ongoing psychotropic medication (unless stabilized for three months) Indication of suicidal ideation, as assessed by item 9 of the PHQ-9 Meets criteria for alcohol or substance use disorder Meets criteria for serious mental disorder, such as bipolar disorder, schizophrenia or psychosis Balance and/or eyesight problems (such as lack of stereoscopic vision) that could interfere with VR treatment

Ages Eligible for Study
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Minimum Age: 18 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: OST treatment with in-vivo spiders<br>OST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling. | Other: OST treatment with in-vivo spiders<br>* Subjects are exposed to phobic stimuli with the aid of a trained psychotherapist during a session of maximum 3 hrs duration. The intensity of exposure is increased in four sequential steps, 1. learning to catch a spider with a glass and paper, 2. touching a spider, 3. letting a spider walk on your hand, 4. letting a spider walk on your body. These stages repeat with increasingly larger spiders. The goal of therapy is not absolute symptom reduction but sufficient reduction to allow the individual to expose themselves in everyday situations.<br>|
| Experimental: VR-OST treatment with virtual spiders<br>VR-OST consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist. | Other: VR-OST treatment with virtual spiders<br>* The VR-OST treatment introduces a virtual gamified version of OST treatment using a modern virtual reality headset. Individuals advance themselves through increasing levels of exposure intensity with the assistance of an automated virtual therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Approach Test (BAT) | The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider. | Change from baseline on BAT (1 week) | 
| Behavioral Approach Test (BAT) | The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider. | Change from baseline on BAT (12 week) | 
| Behavioral Approach Test (BAT) | The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider. | Change from baseline on BAT (52 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spider Phobia Questionnaire 31 (SPQ-31) | SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia. | Change from baseline on SPQ-31 (1 week) | 
| Spider Phobia Questionnaire 31 (SPQ-31) | SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia. | Change from baseline on SPQ-31 (12 week) | 
| Spider Phobia Questionnaire 31 (SPQ-31) | SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia. | Change from baseline on SPQ-31 (52 week) | 
| Spider Phobia Questionnaire 31 (SPQ-31) | SPQ-31 features 31 spider-focused scenarios which must be answered by a yes/no response, with ascending scores indicative of increased degree of arachnophobia. | Change from baseline on SPQ-31 (3 year) | 
| Fear of Spiders Questionnaire 18 (FSQ-18) | FSQ-18 features 18 questions about fear and avoidance of spiders. | Change from baseline in FSQ-18 (1 week) | 
| Fear of Spiders Questionnaire 18 (FSQ-18) | FSQ-18 features 18 questions about fear and avoidance of spiders. | Change from baseline in FSQ-18 (12 week) | 
| Fear of Spiders Questionnaire 18 (FSQ-18) | FSQ-18 features 18 questions about fear and avoidance of spiders. | Change from baseline in FSQ-18 (52 week) | 
| Fear of Spiders Questionnaire 18 (FSQ-18) | FSQ-18 features 18 questions about fear and avoidance of spiders. | Change from baseline in FSQ-18 (3 year) | 
| Generalized Anxiety Disorder Assessment 7 (GAD-7) | GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder. | Change from baseline in GAD-7 (1 week) | 
| Generalized Anxiety Disorder Assessment 7 (GAD-7) | GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder. | Change from baseline in GAD-7 (12 week) | 
| Generalized Anxiety Disorder Assessment 7 (GAD-7) | GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder. | Change from baseline in GAD-7 (52 week) | 
| Generalized Anxiety Disorder Assessment 7 (GAD-7) | GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder. | Change from baseline in GAD-7 (3 year) | 
| Patient Health Questionnaire 9 (PHQ-9) | PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population. | Change from baseline in PHQ-9 (1 week) | 
| Patient Health Questionnaire 9 (PHQ-9) | PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population. | Change from baseline in PHQ-9 (12 week) | 
| Patient Health Questionnaire 9 (PHQ-9) | PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population. | Change from baseline in PHQ-9 (52 week) | 
| Patient Health Questionnaire 9 (PHQ-9) | PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population. | Change from baseline in PHQ-9 (3 year) | 
| Brunnsviken Brief Quality of Life Scale (BBQ) | BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction. | Change from baseline in BBQ (1 week) | 
| Brunnsviken Brief Quality of Life Scale (BBQ) | BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction. | Change from baseline in BBQ (12 week) | 
| Brunnsviken Brief Quality of Life Scale (BBQ) | BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction. | Change from baseline in BBQ (52 week) | 
| Brunnsviken Brief Quality of Life Scale (BBQ) | BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction. | Change from baseline in BBQ (3 year) | 
| Diagnostic criteria for specific phobia according to interview (DSM-5) |  | Change from baseline for specific phobia (DSM-5) (12 weeks) | 
| Diagnostic criteria for specific phobia according to interview (DSM-5) |  | Change from baseline for specific phobia (DSM-5) (52 weeks) | 
| Diagnostic criteria for specific phobia according to interview (DSM-5) |  | Change from baseline for specific phobia (DSM-5) (3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Specific phobia, Exposure therapy, Virtual reality, Randomized controlled trial