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

Stockholm University1 site in 1 country100 target enrollmentAugust 1, 2015

ConditionsPhobia, Specific

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Phobia, Specific
Sponsor: Stockholm University
Enrollment: 100
Locations: 1
Primary Endpoint: Behavioral Approach Test (BAT)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 1, 2015

End Date

April 30, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Stockholm University

Responsible Party

Principal Investigator

Per Carlbring

Professor of Psychology and Head of subdivision of Clinical Psychology

Stockholm University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Behavioral Approach Test (BAT)

Time Frame: Change from baseline on BAT (52 week)

The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

Secondary Outcomes

Generalized Anxiety Disorder Assessment 7 (GAD-7)(Change from baseline in GAD-7 (3 year))
Patient Health Questionnaire 9 (PHQ-9)(Change from baseline in PHQ-9 (3 year))
Spider Phobia Questionnaire 31 (SPQ-31)(Change from baseline on SPQ-31 (3 year))
Brunnsviken Brief Quality of Life Scale (BBQ)(Change from baseline in BBQ (3 year))
Fear of Spiders Questionnaire 18 (FSQ-18)(Change from baseline in FSQ-18 (3 year))
Diagnostic criteria for specific phobia according to interview (DSM-5)(Change from baseline for specific phobia (DSM-5) (3 years))