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Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights (VRAP-Basel)

P

Prof. Dominique de Quervain, MD

Status

Completed

Conditions

Fear of Heights

Treatments

Other: VR App

Study type

Interventional

Funder types

Other

Identifiers

NCT04003753
2018-01504

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Exposure
Experimental group
Description:
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.
Treatment:
Other: VR App
Control
No Intervention group
Description:
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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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