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

NCT ID: NCT02533310

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2019-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

OST treatment with in-vivo spiders

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

VR-OST treatment with virtual spiders

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: lead

Responsible Party

Per Carlbring

Professor of Psychology and Head of subdivision of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Carlbring, PhD

Role: PRINCIPAL_INVESTIGATOR

Stockholm University

Locations

Department of Psychology

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 31075675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26833396 (View on PubMed)

Other Identifiers

VIMSE

Identifier Type: -

Identifier Source: org_study_id