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

NCT ID: NCT04003753

Last Updated: 2019-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-05-24

Brief 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

Fear of Heights

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Exposure

Study phase 1: The experimental intervention in the experimental group consists of three 20-minutes VR exposures (total duration in VR: 60 minutes).

Study phase 2: The experimental intervention in the experimental group consists of six 30-minutes VR exposures as home training (total duration in VR: 3 hours) within two weeks.

Group Type: EXPERIMENTAL

VR App

Intervention Type: OTHER

Participants 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.

Control

Study phase 1: The control group will not receive any active treatment. Instead they will use an App to make virtual tours (three times 20 minutes, total duration in VR: 60 minutes).

Study phase 2: The control group will not receive any active treatment (untreated comparison group).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VR App

Participants 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical fear of heights (DSM-V) or subclinical fear of heights (fulfilment of DSM-C criteria A-E and G, but not F: distress/impairment)
• Physically healthy
• Aged between 18-60
• Fluent in German

Exclusion Criteria

• Depression (BDI-II > 8)
• Suicidal ideation (BDI-II item 9 > 0)
• Concurrent psychotherapy or pharmacotherapy
• Previous therapy for height phobia
• Parallel participation in another study
• Pregnancy (will be excluded with a pregnancy test during screening)
• Chronic medication intake (except oral contraceptives)
• Alcohol and medication intake before visit (less than 12 h)
• Cannabis or other psychoactive substances (including benzodiazepines) intake before visit (less than 5 days)
• Sleep-inducing drugs (incl. antihistamines) intake before visit (less than five days)
• Restricted 3D sight

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Prof Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique de Quervain, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2018-01504

Identifier Type: -

Identifier Source: org_study_id