Overview

This trial is active, not recruiting.

Condition phobia, specific
Treatments ost treatment with in-vivo spiders, vr-ost treatment with virtual spiders
Sponsor Stockholm University
Start date August 2015
End date February 2017
Trial size 100 participants
Trial identifier NCT02533310, VIMSE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
OST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling.
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 consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist.
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.

Primary Outcomes

Measure
Behavioral Approach Test (BAT)
time frame: Change from baseline on BAT (1 week)
Behavioral Approach Test (BAT)
time frame: Change from baseline on BAT (12 week)
Behavioral Approach Test (BAT)
time frame: Change from baseline on BAT (52 week)

Secondary Outcomes

Measure
Spider Phobia Questionnaire 31 (SPQ-31)
time frame: Change from baseline on SPQ-31 (1 week)
Spider Phobia Questionnaire 31 (SPQ-31)
time frame: Change from baseline on SPQ-31 (12 week)
Spider Phobia Questionnaire 31 (SPQ-31)
time frame: Change from baseline on SPQ-31 (52 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
time frame: Change from baseline in FSQ-18 (1 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
time frame: Change from baseline in FSQ-18 (12 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
time frame: Change from baseline in FSQ-18 (52 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
time frame: Change from baseline in GAD-7 (1 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
time frame: Change from baseline in GAD-7 (12 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
time frame: Change from baseline in GAD-7 (52 week)
Patient Health Questionnaire 9 (PHQ-9)
time frame: Change from baseline in PHQ-9 (1 week)
Patient Health Questionnaire 9 (PHQ-9)
time frame: Change from baseline in PHQ-9 (12 week)
Patient Health Questionnaire 9 (PHQ-9)
time frame: Change from baseline in PHQ-9 (52 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
time frame: Change from baseline in BBQ (1 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
time frame: Change from baseline in BBQ (12 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
time frame: Change from baseline in BBQ (52 week)
Diagnostic criteria for specific phobia according to interview (DSM-5)
time frame: Change from baseline for specific phobia (DSM-5) (12 weeks)
Diagnostic criteria for specific phobia according to interview (DSM-5)
time frame: Change from baseline for specific phobia (DSM-5) (52 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial
Principal investigator Per Carlbring, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Stockholm University.