Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders

Fear of Spiders Clinical Trial

— GARET2019  

Official title:

Randomized Controlled Trial on the Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162509
• Other study ID #: 2018-00432
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: December 4, 2019

Study information

• Verified date: December 2019
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fear of Spiders
• Phobic Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported change in disgust of spiders	For the self-reported change of disgust of spiders participants were asked to self-rate their subjective change in disgust 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).	6 weeks after day one (4 weeks after completion of home training)
Other	AR exposure app acceptability and usability scale	The AR exposure app acceptability and usability scale consists of 11 items that assess the overall acceptability and usability (e.g. design, functionality) of the AR app for the experimental group. The items were solely composed for our study purposes. The first 9 items will be assessed through a 11-point scale, item 10 and 11 have an open answer format. Higher scores indicate higher acceptability and usability.	6 weeks after day one (4 weeks after completion of home training)
Other	Credibility/Expactancy scale	The experimental groups therapy expectations regarding the successful treatment of their fear will be measured by an adapted credibility/expectancy for improvement scales with 5 statements. Participants rate their expectancy on a 11-point Likert-type scale (0 = not at all, 10 = absolutely, range 0 - 10) (Borkovec & Nau, 1972)	On study day one
Primary	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.	6 weeks after day one (4 weeks after completion of home training)
Secondary	Performance Behavioural Approach Test (BAT) in vivo	See primary outcome for a detailed description.	6 weeks after day one (4 weeks after completion of home training)
Secondary	Subjective disgust (SUDS) in the in vivo BAT	See primary outcome for a detailed description.	6 weeks after day one (4 weeks after completion of home training)
Secondary	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)	6 weeks after day one (4 weeks after completion of home training)
Secondary	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)	6 weeks after day one (4 weeks after completion of home training)
Secondary	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)	6 weeks after day one (4 weeks after completion of home training)
Secondary	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).	6 weeks after day one (4 weeks after completion of home training)