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

Phobia, Specific Clinical Trial

— VIMSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533310
• Other study ID #: VIMSE
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2021
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phobia, Specific
• Phobic Disorders

Intervention

Other:
• OST treatment with in-vivo spiders
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.
• VR-OST treatment with virtual spiders
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.

Locations

Country	Name	City	State
Sweden	Department of Psychology	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Miloff A, Lindner P, Dafgård P, Deak S, Garke M, Hamilton W, Heinsoo J, Kristoffersson G, Rafi J, Sindemark K, Sjölund J, Zenger M, Reuterskiöld L, Andersson G, Carlbring P. Automated virtual reality exposure therapy for spider phobia vs. in-vivo one-sess — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Diagnostic criteria for specific phobia according to interview (DSM-5)		Change from baseline for specific phobia (DSM-5) (12 weeks)
Secondary	Diagnostic criteria for specific phobia according to interview (DSM-5)		Change from baseline for specific phobia (DSM-5) (52 weeks)
Secondary	Diagnostic criteria for specific phobia according to interview (DSM-5)		Change from baseline for specific phobia (DSM-5) (3 years)