Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
NCT ID: NCT04162509
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-10-07
2019-12-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Exposure
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.
AR app
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.
Control
The control group will not receive any active treatment (untreated comparison group).
No interventions assigned to this group
Interventions
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AR app
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.
Eligibility Criteria
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Inclusion Criteria
* BAT score before exposure between 1-8
* Physically healthy
* Fluent in German
Exclusion Criteria
* 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)
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Swiss National Science Foundation
OTHER
Prof. Dominique de Quervain, MD
OTHER
Responsible Party
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Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
Principal Investigators
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Dominique de Quervain, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Basel
Locations
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University of Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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2018-00432
Identifier Type: -
Identifier Source: org_study_id