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

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

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.

Study Overview

• Status: Completed
• Conditions: Phobia, Specific
• Intervention / Treatment: Other: OST treatment with in-vivo spiders; Other: VR-OST treatment with virtual spiders

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OST treatment with in-vivo spiders; 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; 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.
Experimental: VR-OST treatment with virtual spiders; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Stockholm University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Virtual reality; Exposure therapy; Specific phobia
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders
• Other Study ID Numbers: VIMSE