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

NCT02533310 | Completed

• 1 other identifier: VIMSE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia, Specific

Keywords

Specific phobia; Exposure therapy; Virtual reality; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (23)

• Spider Phobia Questionnaire 31 (SPQ-31)

  Change from baseline on SPQ-31 (1 week)

• Spider Phobia Questionnaire 31 (SPQ-31)

  Change from baseline on SPQ-31 (12 week)

• Spider Phobia Questionnaire 31 (SPQ-31)

  Change from baseline on SPQ-31 (52 week)

• Spider Phobia Questionnaire 31 (SPQ-31)

  Change from baseline on SPQ-31 (3 year)

• Fear of Spiders Questionnaire 18 (FSQ-18)

  Change from baseline in FSQ-18 (1 week)

Study Arms (2)

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.

Other: OST treatment with in-vivo spiders

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.

Other: VR-OST treatment with virtual spiders

Interventions

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.

OST treatment with in-vivo spiders

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.

VR-OST treatment with virtual spiders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stockholm University: lead

Study Sites (1)

Department of Psychology

Stockholm, 10691, Sweden

Location

Related Publications (2)

• 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.

  PMID: 31075675 RESULT

• 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.

  PMID: 26833396 DERIVED

MeSH Terms

Conditions

Phobia, Specific

Study Officials

• Per Carlbring, PhD

  Stockholm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology and Head of subdivision of Clinical Psychology

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 30, 2019
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

SE (1)