Clinical trial NCT04162509: Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
Official title: Randomized Controlled Trial on the Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Spiders
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2019-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-blind study design
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Fear of spiders
* BAT score before exposure between 1-8
* Physically healthy
* Fluent in German

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Subjective fear (SUDS) in the in vivo BAT
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
Secondary outcomes:
measure: Performance Behavioural Approach Test (BAT) in vivo
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Subjective disgust (SUDS) in the in vivo BAT
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Fear of spiders Questionnaire (FSQ)
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Spider Beliefs Questionnaire (SBQ)
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Clinical rating for specific phobia (DSM-V)
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Self-reported change in fear of spiders
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
Other outcomes:
measure: Self-reported change in disgust of spiders
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: AR exposure app acceptability and usability scale
timeFrame: 6 weeks after day one (4 weeks after completion of home training)
measure: Credibility/Expactancy scale
timeFrame: On study day one
Locations:
city: Basel
country: Switzerland
facility: University of Basel
state: BS
Study officials:
affiliation: University of Basel
name: Dominique de Quervain, Prof.
role: PRINCIPAL_INVESTIGATOR
References: