Clinical Trials Directory

Trials / Completed

CompletedNCT04003753

Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights

Randomized Controlled Trial on the Efficacy of a Virtual Reality Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Prof. Dominique de Quervain, MD · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights.

Detailed description

The study will be conducted as a randomized controlled between subject trial. The study consists of two study phases. In study phase 1 the experimental group takes part in three VR exposure sessions (duration 20min each), whereas the control group takes part in three virtual tours (duration 20min each). All VR sessions and assessments of outcomes will be conducted on one study day for each participant. In study phase 2 the experimental group will participate in a home training, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group). Assessment of outcomes will be conducted 3-5 weeks after completion of home trainings. Group 1 (experimental group) consists of individuals with clinical and subclinical fear of heights, that will receive a three-session VR exposure (study phase 1) and take part in a 2-week treatment period with the same VR scenarios (study phase 2). Group 2 (control group) consists of individuals with clinical and subclinical fear of heights that will not receive any active treatment, but will participate in fear-unrelated tasks in study phase 1 or receive no treatment at all (study phase 2). This design allows a direct comparison and therefore an estimation of the effectiveness of the VR exposure therapy. Before and after the virtual exposure/tours participants will undergo an in vivo BAT to assess the effects of the VR exposure therapy. 80 participants between 18 and 60 years with clinical or subclinical fear of heights will take part in the study. Two to three months after having finished study phase 1 the participants will be contacted again and asked to take part in study phase 2. All participants undergo a third in vivo BAT during study phase 2. The BAT will take place 3-5 weeks after completion of the home training.

Conditions

Interventions

TypeNameDescription
OTHERVR AppParticipants will be exposed in three different virtual height scenarios (rural mountain, urban town, cloudy weather). At the beginning of each exposure session participants will be standing on a virtual platform at ground level (level 0). From level 0 they will proceed to further levels according to a predefined exposure scheme based on SUDS ratings (scale 0=no fear to 10=extreme fear). Participants will have to stay at each level until their SUDS are 3 or below for two times consecutively (assessment via gaze selection). In each scenario there will be 15 different height levels available (corresponding to a range of heights between 1-75m). Each exposure session will be terminated by a time limit of 20 minutes (study phase 1) or 30 minutes (study phase 2) irrespective of achieved level.

Timeline

Start date
2018-10-16
Primary completion
2019-05-24
Completion
2019-05-24
First posted
2019-07-01
Last updated
2019-07-01

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04003753. Inclusion in this directory is not an endorsement.