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Completed

NCT Number: NCT04162509

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.

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Key information

Conditions

Fear of Spiders Arachnophobia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR app

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Performance Behavioural Approach Test (BAT) in vivo

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    See primary outcome for a detailed description.

  2. Subjective disgust (SUDS) in the in vivo BAT

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    See primary outcome for a detailed description.

  3. Fear of spiders Questionnaire (FSQ)

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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)

  4. Spider Beliefs Questionnaire (SBQ)

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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)

  5. Clinical rating for specific phobia (DSM-V)

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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. Self-reported change in fear of spiders

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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).

Other outcomes

  1. Self-reported change in disgust of spiders

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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).

  2. AR exposure app acceptability and usability scale

    Time frame: 6 weeks after day one (4 weeks after completion of home training)

    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.

  3. Credibility/Expactancy scale

    Time frame: On study day one

    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)

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: GARET2019

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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