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

Not Applicable

Completed

• Conditions: Phobia, Specific
• Interventions: Other: VR-OST treatment with virtual spiders; Other: OST treatment with in-vivo spiders

• Registration Number: NCT02533310
• Lead Sponsor: Stockholm University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-26
• Primary Completion: 2018-12
• Study Completion: 2019-04-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR-OST treatment with virtual spiders	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.
OST treatment with in-vivo spiders	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.

Primary Outcome Measures

Name	Time	Method
Behavioral Approach Test (BAT)	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 Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder Assessment 7 (GAD-7)	Change from baseline in GAD-7 (3 year)	GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Patient Health Questionnaire 9 (PHQ-9)	Change from baseline in PHQ-9 (3 year)	PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Spider Phobia Questionnaire 31 (SPQ-31)	Change from baseline on SPQ-31 (3 year)	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.
Brunnsviken Brief Quality of Life Scale (BBQ)	Change from baseline in BBQ (3 year)	BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Fear of Spiders Questionnaire 18 (FSQ-18)	Change from baseline in FSQ-18 (3 year)	FSQ-18 features 18 questions about fear and avoidance of spiders.
Diagnostic criteria for specific phobia according to interview (DSM-5)	Change from baseline for specific phobia (DSM-5) (3 years)

Trial Locations

Locations (1)

Department of Psychology; 🇸🇪 Stockholm, Sweden