Fear of SpidersGARET2019NCT04162509
Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
A study testing AR app in people with Fear of Spiders, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Spiders
- What is being tested?
- AR app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2019to 4 Dec 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fear of spiders
- BAT score before exposure between 1-8
- Physically healthy
- Fluent in German
Who cannot join
- BDI-II sumscore >=20 and/or item 9 >=1
- Concurrent psychotherapy or pharmacotherapy
- Previous exposure-based therapy for spider phobia
- Parallel participation in another study
- Chronic medication intake (except oral contraceptives)
- Medication intake before visits (less than 24h)
Show all 9Show fewer
- Alcohol intake before visits (less than 12 h)
- Cannabis or other psychoactive substances (including benzodiazepines) intake before visits (less than 5 days)
- For women: Current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders.
Read the detailed description
The study will be conducted as a randomized controlled between subject trial. The study consists of two visits and a home training for one group. 60 participants between 18 and 40 years with clinical or subclinical fear of spiders will take part in the study.
All assessments of outcome will be conducted on one visit for each participant, including an in vivo BAT. The experimental group will participate in a home training with the app, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group).
Six weeks after the first visit all participants undergo the assessments of outcome, including a second in vivo BAT. The BAT will take place 4 weeks after completion of the home training. This design allows a direct comparison and therefore an estimation of the efficacy of the gamified AR exposure therapy.
- Conditions
- Fear of Spiders
- Being tested
- AR app
- Medical subject headings
- Arachnophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR appOther
Participants will be exposed to nine different AR spider scenarios with a pre-defined length of 2 minutes for each level. Each level starts with a surface scan of the environment and the placement of the AR spider model(s) by tapping on the display. Through small text pop-ups the user is instructed to perform different tasks (e.g. looking at the spider model, approaching it, holding the hand under the model). They proceed to further levels according to a predefined exposure scheme based on SUDS for fear (scale 0=no fear to 10=maximum fear) and disgust (scale 0=no disgust to 10=maximum disgust) and the assurance of the task completed (yes/no). Users will repeat each level until their SUDS are 4 or below and have completed the task. Each exposure session is limited to approx. 30 minutes (controlled by the participants) irrespective of achieved level.
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Experimental | The experimental intervention in the experimental group consists of six 30-minutes AR exposures as home training (total duration in AR: 3 hours) within two weeks. Receives: Other: AR app |
| Control | No intervention | The control group will not receive any active treatment (untreated comparison group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective fear (SUDS) in the in vivo BAT
During the BAT participants will be placed in front of a closed room with a spider in it and will be asked to open the door and approach a living house spider measuring about 5 cm, which will be placed in a sealed transparent plastic container on a table at the far end of the room. The participant will be requested to approach the spider and if possible, to touch the container, to remove the lid, insert a hand, and try to pick up and hold the spider for at least 20 s. Pre-defined scores ranging from 0 = refuses to enter the test room to 12 = holds the spider for at least 20 s will be given when the BAT was completed after 3 minutes or terminated by the participant. SUDS for fear and disgust will be taken during the BAT on the same score as on day one, ranging from 0 = no fear to 10 = maximum fear.
Measured: 6 weeks after day one (4 weeks after completion of home training)
Secondary outcomes (6)
Performance Behavioural Approach Test (BAT) in vivo
See primary outcome for a detailed description.
Measured: 6 weeks after day one (4 weeks after completion of home training)
Subjective disgust (SUDS) in the in vivo BAT
See primary outcome for a detailed description.
Measured: 6 weeks after day one (4 weeks after completion of home training)
Fear of spiders Questionnaire (FSQ)
The FSQ measures avoidance behavior as well as fear of harm and consists of 18 spider relevant situations. Participants evaluate their relationship to spiders on a 7-point Likert-type scale (0 = not at all true to 6 = absolutely true, range 0 - 108) (Szymanski and O'Donohue, 1995)
Measured: 6 weeks after day one (4 weeks after completion of home training)
Spider Beliefs Questionnaire (SBQ)
The SBQ assesses specifically spider-related catastrophic cognitions that will be challenged within the exposure sessions and consists of 48 possible thoughts and beliefs in spider situations. Participants evaluate whether they are convinced these beliefs are true while being in a spider situation with a percentage (0 = not at all convinced to 100 = firmly convinced) (Arntz et al. 1993)
Measured: 6 weeks after day one (4 weeks after completion of home training)
Clinical rating for specific phobia (DSM-V)
Fear of spiders will be re-assessed by the section for specific phobia (animal type: spider) of the structured diagnostic interview for mental disorders for DSM-V (DIPS, Schneider \& Margraf, 2017)
Measured: 6 weeks after day one (4 weeks after completion of home training)
Self-reported change in fear of spiders
For the self-reported change of fear of spiders participants were asked to self-rate their subjective change in fear of spiders on a single visual analogue scale in a range of 0 to 100 (0 = a lot worse, 50 = no change and 100 = a lot better).
Measured: 6 weeks after day one (4 weeks after completion of home training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start7 Oct 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of SpidersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, Prof., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162509
- Sponsor's protocol ID
- 2018-00432
- Other IDs
- 2018
- Acronym
- GARET2019
- Status last verified
- Dec 2019
- First submitted
- 11 Nov 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
- ClinicalTrials.gov ID
- NCT04162509
- Acronym / sponsor ID
- GARET2019 / 2018-00432
- Conditions
- Fear of Spiders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 14 Nov 2019 (actual)
- 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.
Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders.
Detailed description
The study will be conducted as a randomized controlled between subject trial. The study consists of two visits and a home training for one group. 60 participants between 18 and 40 years with clinical or subclinical fear of spiders will take part in the study.
All assessments of outcome will be conducted on one visit for each participant, including an in vivo BAT. The experimental group will participate in a home training with the app, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group).
Six weeks after the first visit all participants undergo the assessments of outcome, including a second in vivo BAT. The BAT will take place 4 weeks after completion of the home training. This design allows a direct comparison and therefore an estimation of the efficacy of the gamified AR exposure therapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind study design
| Arm | Type | Receives |
|---|---|---|
| Exposure | Experimental | Other: AR appThe experimental intervention in the experimental group consists of six 30-minutes AR exposures as home training (total duration in AR: 3 hours) within two weeks. |
| Control | No intervention | –The control group will not receive any active treatment (untreated comparison group). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fear of spiders
- BAT score before exposure between 1-8
- Physically healthy
- Fluent in German
Key exclusion criteria (9 listed)
- BDI-II sumscore >=20 and/or item 9 >=1
- Concurrent psychotherapy or pharmacotherapy
- Previous exposure-based therapy for spider phobia
- Parallel participation in another study
- Chronic medication intake (except oral contraceptives)
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 |
|---|---|---|
| AR appParticipants will be exposed to nine different AR spider scenarios with a pre-defined length of 2 minutes for each level. Each level starts with a surface scan of the environment and the placement of the AR spider model(s) by tapping on the display. Through small text pop-ups the user is instructed to perform different tasks (e.g. looking at the spider model, approaching it, holding the hand under the model). They proceed to further levels according to a predefined exposure scheme based on SUDS for fear (scale 0=no fear to 10=maximum fear) and disgust (scale 0=no disgust to 10=maximum disgust) and the assurance of the task completed (yes/no). Users will repeat each level until their SUDS are 4 or below and have completed the task. Each exposure session is limited to approx. 30 minutes (controlled by the participants) irrespective of achieved level. | Other | Exposure |
Primary outcome
Subjective fear (SUDS) in the in vivo BAT
Time frame: 6 weeks after day one (4 weeks after completion of home training)
During the BAT participants will be placed in front of a closed room with a spider in it and will be asked to open the door and approach a living house spider measuring about 5 cm, which will be placed in a sealed transparent plastic container on a table at the far end of the room. The participant will be requested to approach the spider and if possible, to touch the container, to remove the lid, insert a hand, and try to pick up and hold the spider for at least 20 s. Pre-defined scores ranging from 0 = refuses to enter the test room to 12 = holds the spider for at least 20 s will be given when the BAT was completed after 3 minutes or terminated by the participant. SUDS for fear and disgust will be taken during the BAT on the same score as on day one, ranging from 0 = no fear to 10 = maximum fear.
6 secondary outcomes
Performance Behavioural Approach Test (BAT) in vivo
Time frame: 6 weeks after day one (4 weeks after completion of home training)
Subjective disgust (SUDS) in the in vivo BAT
Time frame: 6 weeks after day one (4 weeks after completion of home training)
Fear of spiders Questionnaire (FSQ)
Time frame: 6 weeks after day one (4 weeks after completion of home training)
Spider Beliefs Questionnaire (SBQ)
Time frame: 6 weeks after day one (4 weeks after completion of home training)
Clinical rating for specific phobia (DSM-V)
Time frame: 6 weeks after day one (4 weeks after completion of home training)
Self-reported change in fear of spiders
Time frame: 6 weeks after day one (4 weeks after completion of home training)
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 20 Dec 2019.
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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.
Dominique de Quervain, Prof. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR app in people with Fear of Spiders, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
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 9 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 20 Dec 2019. 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 Switzerland. 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?
Subjective fear (SUDS) in the in vivo BAT (time frame: 6 weeks after day one (4 weeks after completion of home training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2019.