| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fear of Heights | Other: VR App | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | randomized controlled single-blind study design |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | 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). |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | October 16, 2018 |
| Actual Primary Completion Date : | May 24, 2019 |
| Actual Study Completion Date : | May 24, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
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
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.
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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). |
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Switzerland | |
| University of Basel, Division of Cognitive Neuroscience | |
| Basel, BS, Switzerland, 4055 | |
| Principal Investigator: | Dominique de Quervain, Prof. | University of Basel |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 24, 2019 | ||||
| First Posted Date ICMJE | July 1, 2019 | ||||
| Last Update Posted Date | July 1, 2019 | ||||
| Actual Study Start Date ICMJE | October 16, 2018 | ||||
| Actual Primary Completion Date | May 24, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Performance Behavioural Avoidance Test (BAT) in vivo [ Time Frame: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: randomized controlled single-blind study design Masking: Double (Participant, Outcomes Assessor)Masking Description: 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). Primary Purpose: Other
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| Condition ICMJE | Fear of Heights | ||||
| Intervention ICMJE | Other: 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
80 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | May 24, 2019 | ||||
| Actual Primary Completion Date | May 24, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04003753 | ||||
| Other Study ID Numbers ICMJE | 2018-01504 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Prof. Dominique de Quervain, MD, University of Basel | ||||
| Study Sponsor ICMJE | Prof. Dominique de Quervain, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Basel | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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