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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OST treatment with in-vivo spiders | Experimental | OST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling. |
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| VR-OST treatment with virtual spiders | Experimental | VR-OST consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OST treatment with in-vivo spiders | Other | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Carlbring, PhD | Stockholm University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology | Stockholm | 10691 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31075675 | Result | Miloff A, Lindner P, Dafgard P, Deak S, Garke M, Hamilton W, Heinsoo J, Kristoffersson G, Rafi J, Sindemark K, Sjolund J, Zenger M, Reuterskiold L, Andersson G, Carlbring P. Automated virtual reality exposure therapy for spider phobia vs. in-vivo one-session treatment: A randomized non-inferiority trial. Behav Res Ther. 2019 Jul;118:130-140. doi: 10.1016/j.brat.2019.04.004. Epub 2019 Apr 16. | |
| 26833396 |
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| ID | Term |
|---|---|
| C562465 | Phobia, Specific |
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| VR-OST treatment with virtual spiders | Other | 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. |
|
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) |
| Derived |
| Miloff A, Lindner P, Hamilton W, Reuterskiold L, Andersson G, Carlbring P. Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. Trials. 2016 Feb 2;17:60. doi: 10.1186/s13063-016-1171-1. |