Clinical trial NCT04003753: Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Heights
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled single-blind study design
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Performance Behavioural Avoidance Test (BAT) in vivo
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Secondary outcomes:
measure: Acrophobia Questionnaire (AQ)
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
measure: Attitudes Towards Heights Questionnaire (ATHQ)
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
measure: Anxiety Expectancy Scale (AES)
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
measure: Danger Expectancy Scale (DES)
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Other outcomes:
measure: VR exposure app acceptability and usability scale
timeFrame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
measure: Igroup Presence Questionnaire (IPQ)
timeFrame: study phase 1: on study day directly (within 1h) after VR exposure
measure: Subjective Units of Distress Scale (SUDS)
timeFrame: on study day during VR exposure
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: study phase 1: on study day directly (within 1h) after VR exposure
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
state: BS
Study officials:
affiliation: University of Basel
name: Dominique de Quervain, Prof.
role: PRINCIPAL_INVESTIGATOR
References: