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

NCT04162509 | Completed

• 1 other identifier: 2018-00432
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fear of Spiders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Performance Behavioural Approach Test (BAT) in vivo

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

• Subjective disgust (SUDS) in the in vivo BAT

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

• Fear of spiders Questionnaire (FSQ)

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

• Spider Beliefs Questionnaire (SBQ)

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

• Clinical rating for specific phobia (DSM-V)

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

Other Outcomes (3)

• Self-reported change in disgust of spiders

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

• AR exposure app acceptability and usability scale

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

• Credibility/Expactancy scale

  On study day one

Study Arms (2)

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.

Other: AR app

Control

NO INTERVENTION

The control group will not receive any active treatment (untreated comparison group).

Interventions

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.

Exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Arachnophobia

Study Officials

• Dominique de Quervain, Prof.

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly (matched by clinical relevance of fear of spiders and sex) allocated to treatment groups (experimental group, control group). The experimenter evaluating the primary outcome will be blinded (unaware of group assignment of participants, single-blind).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Division of Cognitive Neuroscience

Model Details: Randomized controlled single-blind study design

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: October 7, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

CH (1)