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

Lead sponsor

Prof. Dominique de Quervain, MD is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  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.

  Other: VR App

• No intervention
  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).

Interventions

• OtherVR 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.

Primary outcomes

1. Performance Behavioural Avoidance Test (BAT) in vivo

   Change in BAT performance after VR exposure from baseline (before VR exposure). During the BAT participants will be requested to climb up to the Uetliberg Tower while continuously looking to the ground level. Participants will be asked to only proceed as far as their anxiety allows them. On each of the 14 platforms participants will be asked to lean on a predefined area of the railing (and touch it with their upper body) and to look down to the ground for 10 seconds, if their fear allows them to do so. The BAT will be terminated as soon as the participant indicates feeling uncomfortable to proceed (adapted from Emmelkamp, 2002 and Coelho, 2006) or the 10 minutes period, given to them to perform the complete task, runs out.

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

Secondary outcomes

1. Acrophobia Questionnaire (AQ)

   Change in AQ after VR exposure from baseline (before VR exposure).This questionnaire describes twenty situations that can cause fear of heights (e.g., driving over a bridge, walking over a sidewalk grating, or sitting on an airplane) and asks for anxiety ratings on a 7-point Likert-type scale (0 = not at all afraid to 6 = very afraid, range 0-120, α = 0.80) (Cohen, 1977).

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

2. Attitudes Towards Heights Questionnaire (ATHQ)

   Change in ATHQ after VR exposure from baseline (before VR exposure).The ATHQ consists of six questions assessing participants' attitudes towards heights situations (e.g., "I think heights are … good - bad, secure - insecure"). Patients evaluate their attitudes towards heights by twelve adjectives on an 11-point scale ranging from a positive (0) to a negative (10) adjective (range 0-60; α = 0.81).

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

3. Anxiety Expectancy Scale (AES)

   Change in AES after VR exposure from baseline (before VR exposure). The AES assesses anxiety symptoms in a height situation. The AES consists of ten items describing anxiety symptoms (e.g., "you could feel dizzy"). Participants rate the likelihood of experiencing these symptoms while being in a height situation on a five-point scale (range 10-50) (Gursky \& Reiss, 1987).

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

4. Danger Expectancy Scale (DES)

   The DES assesses dysfunctional cognitions. The DES consists of five items. Participants rate the likelihood that each of the listed harmful events (e.g., "you might slip and fall over the guard rail on the observation deck") will pass through their minds while being in a height situation on a five-point scale (not likely at all (1), probably not (2) maybe (3), quite likely (4), or definitely (5), range 5-25) (Gursky \& Reiss, 1987).

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

Other outcomes

1. VR exposure app acceptability and usability scale

   The VR exposure app acceptability and usability scale consists of 10 items (study phase 1)/11 items (study phase 2) that assess the overall acceptability and usability (e.g. design, functionality) of the VR app. The items were solely composed for our study purposes. The first 9 items will be assessed through a 11-point scale, item 10 and 11 have an open answer format. Higher scores indicate higher acceptability and usability.

   Time frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training

2. Igroup Presence Questionnaire (IPQ)

   The IPQ assess participants' presence while being in VR. The IPQ consists of 14 items with a 7-point scale (0-6) that concern the participants' sense of being in the virtual environment, for example, the extent to which virtual reality was "real" to them, whether they thought of the virtual environment more as images they saw or more as a situation they were in, how much attention they paid to the real world, and the extent to which they focused on the virtual task. The IPQ consists of three subscales: Spatial Presence (range 0-30), Involvement (range 0-24), Realness (range 0-12), higher scores indicate stronger presence (Schubert, 2003).

   Time frame: study phase 1: on study day directly (within 1h) after VR exposure

3. Subjective Units of Distress Scale (SUDS)

   Participants in the experimental group will be prompted to give their SUDS during the VR heights exposure sessions at predefined time points (first rating on each level after 10 seconds, then every 30 seconds until allowed to enter the next level. Then again first rating after 10 seconds, then every 30 seconds until allowed to enter the next level and so on (scale 0=no fear to 10=extreme fear).

   Time frame: on study day during VR exposure

4. Simulator Sickness Questionnaire (SSQ)

   Assessment of potential side effects of VR immersion. Possible symptoms (e.g. headache, nausea) will be assessed directly before (baseline) and after the VR exposure on a scale between 0-3. The change from baseline will be evaluated.

   Time frame: study phase 1: on study day directly (within 1h) after VR exposure