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

Primary Purpose

Phobia, Specific

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

OST treatment with in-vivo spiders

VR-OST treatment with virtual spiders

About this trial

This is an interventional treatment trial for Phobia, Specific focused on measuring Specific phobia, Exposure therapy, Virtual reality, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

OST treatment with in-vivo spiders

VR-OST treatment with virtual spiders

Arm Description

OST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling.

VR-OST consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Spider Phobia Questionnaire 31 (SPQ-31)

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.

Spider Phobia Questionnaire 31 (SPQ-31)

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.

Spider Phobia Questionnaire 31 (SPQ-31)

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.

Spider Phobia Questionnaire 31 (SPQ-31)

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.

Fear of Spiders Questionnaire 18 (FSQ-18)

FSQ-18 features 18 questions about fear and avoidance of spiders.

Fear of Spiders Questionnaire 18 (FSQ-18)

FSQ-18 features 18 questions about fear and avoidance of spiders.

Fear of Spiders Questionnaire 18 (FSQ-18)

FSQ-18 features 18 questions about fear and avoidance of spiders.

Fear of Spiders Questionnaire 18 (FSQ-18)

FSQ-18 features 18 questions about fear and avoidance of spiders.

Generalized Anxiety Disorder Assessment 7 (GAD-7)

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Generalized Anxiety Disorder Assessment 7 (GAD-7)

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Generalized Anxiety Disorder Assessment 7 (GAD-7)

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Generalized Anxiety Disorder Assessment 7 (GAD-7)

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Patient Health Questionnaire 9 (PHQ-9)

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Patient Health Questionnaire 9 (PHQ-9)

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Patient Health Questionnaire 9 (PHQ-9)

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Patient Health Questionnaire 9 (PHQ-9)

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Brunnsviken Brief Quality of Life Scale (BBQ)

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Brunnsviken Brief Quality of Life Scale (BBQ)

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Brunnsviken Brief Quality of Life Scale (BBQ)

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Brunnsviken Brief Quality of Life Scale (BBQ)

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Diagnostic criteria for specific phobia according to interview (DSM-5)

Full Information

NCT ID

NCT02533310

First Posted

August 24, 2015

Last Updated

February 15, 2021

Sponsor

Stockholm University

1. Study Identification

Unique Protocol Identification Number

NCT02533310

Brief Title

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

Acronym

VIMSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2015 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stockholm University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phobia, Specific

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OST treatment with in-vivo spiders

Arm Type

Experimental

Arm Description

OST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling.

Arm Title

VR-OST treatment with virtual spiders

Arm Type

Experimental

Arm Description

VR-OST consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist.

Intervention Type

Other

Intervention Name(s)

OST treatment with in-vivo spiders

Intervention Description

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

Intervention Name(s)

VR-OST treatment with virtual spiders

Intervention Description

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 Outcome Measure Information:

Title

Behavioral Approach Test (BAT)

Description

The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

Time Frame

Change from baseline on BAT (1 week)

Title

Behavioral Approach Test (BAT)

Description

The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

Time Frame

Change from baseline on BAT (12 week)

Title

Behavioral Approach Test (BAT)

Description

The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.

Time Frame

Change from baseline on BAT (52 week)

Secondary Outcome Measure Information:

Title

Spider Phobia Questionnaire 31 (SPQ-31)

Description

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.

Time Frame

Change from baseline on SPQ-31 (1 week)

Title

Spider Phobia Questionnaire 31 (SPQ-31)

Description

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.

Time Frame

Change from baseline on SPQ-31 (12 week)

Title

Spider Phobia Questionnaire 31 (SPQ-31)

Description

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.

Time Frame

Change from baseline on SPQ-31 (52 week)

Title

Spider Phobia Questionnaire 31 (SPQ-31)

Description

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.

Time Frame

Change from baseline on SPQ-31 (3 year)

Title

Fear of Spiders Questionnaire 18 (FSQ-18)

Description

FSQ-18 features 18 questions about fear and avoidance of spiders.

Time Frame

Change from baseline in FSQ-18 (1 week)

Title

Fear of Spiders Questionnaire 18 (FSQ-18)

Description

FSQ-18 features 18 questions about fear and avoidance of spiders.

Time Frame

Change from baseline in FSQ-18 (12 week)

Title

Fear of Spiders Questionnaire 18 (FSQ-18)

Description

FSQ-18 features 18 questions about fear and avoidance of spiders.

Time Frame

Change from baseline in FSQ-18 (52 week)

Title

Fear of Spiders Questionnaire 18 (FSQ-18)

Description

FSQ-18 features 18 questions about fear and avoidance of spiders.

Time Frame

Change from baseline in FSQ-18 (3 year)

Title

Generalized Anxiety Disorder Assessment 7 (GAD-7)

Description

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Time Frame

Change from baseline in GAD-7 (1 week)

Title

Generalized Anxiety Disorder Assessment 7 (GAD-7)

Description

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Time Frame

Change from baseline in GAD-7 (12 week)

Title

Generalized Anxiety Disorder Assessment 7 (GAD-7)

Description

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Time Frame

Change from baseline in GAD-7 (52 week)

Title

Generalized Anxiety Disorder Assessment 7 (GAD-7)

Description

GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.

Time Frame

Change from baseline in GAD-7 (3 year)

Title

Patient Health Questionnaire 9 (PHQ-9)

Description

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Time Frame

Change from baseline in PHQ-9 (1 week)

Title

Patient Health Questionnaire 9 (PHQ-9)

Description

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Time Frame

Change from baseline in PHQ-9 (12 week)

Title

Patient Health Questionnaire 9 (PHQ-9)

Description

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Time Frame

Change from baseline in PHQ-9 (52 week)

Title

Patient Health Questionnaire 9 (PHQ-9)

Description

PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population.

Time Frame

Change from baseline in PHQ-9 (3 year)

Title

Brunnsviken Brief Quality of Life Scale (BBQ)

Description

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Time Frame

Change from baseline in BBQ (1 week)

Title

Brunnsviken Brief Quality of Life Scale (BBQ)

Description

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Time Frame

Change from baseline in BBQ (12 week)

Title

Brunnsviken Brief Quality of Life Scale (BBQ)

Description

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Time Frame

Change from baseline in BBQ (52 week)

Title

Brunnsviken Brief Quality of Life Scale (BBQ)

Description

BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.

Time Frame

Change from baseline in BBQ (3 year)

Title

Diagnostic criteria for specific phobia according to interview (DSM-5)

Time Frame

Change from baseline for specific phobia (DSM-5) (12 weeks)

Title

Diagnostic criteria for specific phobia according to interview (DSM-5)

Time Frame

Change from baseline for specific phobia (DSM-5) (52 weeks)

Title

Diagnostic criteria for specific phobia according to interview (DSM-5)

Time Frame

Change from baseline for specific phobia (DSM-5) (3 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Per Carlbring, PhD

Organizational Affiliation

Stockholm University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Psychology

City

Stockholm

ZIP/Postal Code

10691

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

31075675

Citation

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.

Results Reference

result

PubMed Identifier

26833396

Citation

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.

Results Reference

derived

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

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