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

NCT04003753 | Completed

• 1 other identifier: 2018-01504
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fear of Heights

Outcome Measures

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.

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

Secondary Outcomes (4)

• Acrophobia Questionnaire (AQ)

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

• Attitudes Towards Heights Questionnaire (ATHQ)

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

• Anxiety Expectancy Scale (AES)

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

• Danger Expectancy Scale (DES)

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

Other Outcomes (4)

• VR exposure app acceptability and usability scale

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

• Igroup Presence Questionnaire (IPQ)

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

• Subjective Units of Distress Scale (SUDS)

  on study day during VR exposure

Study Arms (2)

Exposure

EXPERIMENTAL

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

Control

NO INTERVENTION

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

VR App 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.

Exposure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Acrophobia

Study Officials

• Dominique de Quervain, Prof.

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly (matched by clinical relevance of fear of heights and sex) allocated to treatment groups (experimental group, control group). The experimenter evaluating the primary outcome will be blinded (unaware of group assignment of participants, single-blind).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr. med.

Model Details: randomized controlled single-blind study design

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: July 1, 2019
• Study Start: October 16, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

CH (1)