Phobia, SpecificVIMSENCT02533310

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

A study testing OST treatment with in-vivo spiders and VR-OST treatment with virtual spiders in people with Phobia, Specific, run by Stockholm University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Phobia, Specific
What is being tested?: OST treatment with in-vivo spiders and VR-OST treatment with virtual spiders
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteSweden
Study dates: 1 Aug 2015to 30 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Psychology
Stockholm, 10691

Other trials in Sweden

About this study

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

Conditions: Phobia, Specific
Being tested: OST treatment with in-vivo spiders, VR-OST treatment with virtual spiders
Keywords: Specific phobia, Exposure therapy, Virtual reality, Randomized controlled trial
Medical subject headings: Phobia, Specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OST treatment with in-vivo spidersOther
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 spidersOther
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.

Study groups in NCT02533310
Study group	Role	What they receive
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. Receives: 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. Receives: Other: VR-OST treatment with virtual spiders

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Change from baseline on BAT (52 week)

Secondary outcomes (23)

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.
Measured: Change from baseline on SPQ-31 (1 week)
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.
Measured: Change from baseline on SPQ-31 (12 week)
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.
Measured: Change from baseline on SPQ-31 (52 week)
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.
Measured: Change from baseline on SPQ-31 (3 year)
Fear of Spiders Questionnaire 18 (FSQ-18)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Measured: Change from baseline in FSQ-18 (1 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Measured: Change from baseline in FSQ-18 (12 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Measured: Change from baseline in FSQ-18 (52 week)
Fear of Spiders Questionnaire 18 (FSQ-18)
FSQ-18 features 18 questions about fear and avoidance of spiders.
Measured: Change from baseline in FSQ-18 (3 year)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Measured: Change from baseline in GAD-7 (1 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Measured: Change from baseline in GAD-7 (12 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Measured: Change from baseline in GAD-7 (52 week)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Measured: Change from baseline in GAD-7 (3 year)
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.
Measured: Change from baseline in PHQ-9 (1 week)
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.
Measured: Change from baseline in PHQ-9 (12 week)
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.
Measured: Change from baseline in PHQ-9 (52 week)
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.
Measured: Change from baseline in PHQ-9 (3 year)
Brunnsviken Brief Quality of Life Scale (BBQ)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Measured: Change from baseline in BBQ (1 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Measured: Change from baseline in BBQ (12 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Measured: Change from baseline in BBQ (52 week)
Brunnsviken Brief Quality of Life Scale (BBQ)
BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Measured: Change from baseline in BBQ (3 year)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Measured: Change from baseline for specific phobia (DSM-5) (12 weeks)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Measured: Change from baseline for specific phobia (DSM-5) (52 weeks)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Measured: Change from baseline for specific phobia (DSM-5) (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201530 Apr 2019

First posted26 Aug 2015 (estimated)
Study start1 Aug 2015
Primary completionDec 2018
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Phobia, SpecificStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02533310
Sponsor's protocol ID: VIMSE
Acronym: VIMSE
Status last verified: Feb 2021
First submitted: 24 Aug 2015
Last updated: 17 Feb 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 31075675
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.
PubMed 26833396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Phobia, Specific trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial
ClinicalTrials.gov ID: NCT02533310
Acronym / sponsor ID: VIMSE / VIMSE
Conditions: Phobia, Specific
Keywords: Specific phobia, Exposure therapy, Virtual reality, Randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Stockholm UniversityUniversity, hospital or other
Study start: 1 Aug 2015 (actual)
Primary completion: Dec 2018 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 26 Aug 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OST treatment with in-vivo spiders	Experimental	Other: OST treatment with in-vivo spidersOST consists of increasingly intense interactions with an in-vivo phobic stimuli and human therapist non-phobic behavior modelling.
VR-OST treatment with virtual spiders	Experimental	Other: VR-OST treatment with virtual spidersVR-OST consists of simulated OST treatment without the use of live spiders and with the support of a virtual therapist.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OST treatment with in-vivo spidersSubjects 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.	Other	OST treatment with in-vivo spiders
VR-OST treatment with virtual spidersThe 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.	Other	VR-OST treatment with virtual spiders

Primary outcome

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.
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.
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.

23 secondary outcomes

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)
Spider Phobia Questionnaire 31 (SPQ-31)
Time frame: 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)
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)
Fear of Spiders Questionnaire 18 (FSQ-18)
Time frame: 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)
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)
Generalized Anxiety Disorder Assessment 7 (GAD-7)
Time frame: Change from baseline in GAD-7 (3 year)
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)
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Change from baseline in PHQ-9 (3 year)
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)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: 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)
Diagnostic criteria for specific phobia according to interview (DSM-5)
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Results publication: PubMed 31075675Miloff 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.
Derived from this study: PubMed 26833396Miloff 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Per Carlbring, PhD principal investigator

Stockholm University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OST treatment with in-vivo spiders and VR-OST treatment with virtual spiders in people with Phobia, Specific, run by Stockholm University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavioral Approach Test (BAT) (time frame: Change from baseline on BAT (1 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533310, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.