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

February 15, 2021 updated by: Per Carlbring, Stockholm University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 10691
        • Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavioral Approach Test (BAT)
Time Frame: Change from baseline on BAT (1 week)
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)
Time Frame: Change from baseline on BAT (12 week)
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)
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.
Change from baseline on BAT (52 week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spider Phobia Questionnaire 31 (SPQ-31)
Time Frame: Change from baseline on SPQ-31 (1 week)
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.
Change from baseline on SPQ-31 (1 week)
Spider Phobia Questionnaire 31 (SPQ-31)
Time Frame: Change from baseline on SPQ-31 (12 week)
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.
Change from baseline on SPQ-31 (12 week)
Spider Phobia Questionnaire 31 (SPQ-31)
Time Frame: Change from baseline on SPQ-31 (52 week)
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.
Change from baseline on SPQ-31 (52 week)
Spider Phobia Questionnaire 31 (SPQ-31)
Time Frame: 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.
Change from baseline on SPQ-31 (3 year)
Fear of Spiders Questionnaire 18 (FSQ-18)
Time Frame: Change from baseline in FSQ-18 (1 week)
FSQ-18 features 18 questions about fear and avoidance of spiders.
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)
FSQ-18 features 18 questions about fear and avoidance of spiders.
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)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Change from baseline in FSQ-18 (52 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
Time Frame: Change from baseline in FSQ-18 (3 year)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Change from baseline in FSQ-18 (3 year)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
Time Frame: Change from baseline in GAD-7 (1 week)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
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)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
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)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Change from baseline in GAD-7 (52 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
Time Frame: Change from baseline in GAD-7 (3 year)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Change from baseline in GAD-7 (3 year)
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Change from baseline in PHQ-9 (1 week)
PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Change from baseline in PHQ-9 (1 week)
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Change from baseline in PHQ-9 (12 week)
PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Change from baseline in PHQ-9 (12 week)
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Change from baseline in PHQ-9 (52 week)
PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.
Change from baseline in PHQ-9 (52 week)
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 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.
Change from baseline in PHQ-9 (3 year)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline in BBQ (1 week)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Change from baseline in BBQ (1 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline in BBQ (12 week)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Change from baseline in BBQ (12 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline in BBQ (52 week)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Change from baseline in BBQ (52 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time Frame: Change from baseline in BBQ (3 year)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Change from baseline in BBQ (3 year)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Time Frame: Change from baseline for specific phobia (DSM-5) (12 weeks)
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)
Change from baseline for specific phobia (DSM-5) (52 weeks)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Time Frame: Change from baseline for specific phobia (DSM-5) (3 years)
Change from baseline for specific phobia (DSM-5) (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stockholm University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIMSE

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