Condition category
Mental and Behavioural Disorders
Date applied
01/10/2017
Date assigned
04/10/2017
Last edited
18/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cognitive behavioural therapy (CBT) or exposure therapy delivered by virtual reality (VR) has been shown in a number of studies to be a safe and effective way of reducing anxieties. A state-of-the-art VR cognitive behavioural treatment has been developed for fear of heights that is automated, engaging, and deliverable via the latest consumer equipment. The aim of this study is to test whether the VR treatment reduces fear of heights at the end of treatment, and whether the treatment gains are maintained at follow-up.

Who can participate?
People aged over 18 who report a fear of heights

What does the study involve?
Participants are randomly allocated to receive the VR treatment or no treatment. The VR treatment is provided in six sessions over about a fortnight. Fear of heights is assessed using questionnaires at the start of the study, after treatment, and two weeks after the end of treatment.

What are the possible benefits and risks of participating?
The potential benefits for participants are a reduction in their fear of heights. There are unlikely to be any risks in participating although sometimes people get short-term motion sickness with VR (though this has not been found to occur with this VR set-up).

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
May 2017 to April 2018

Who is funding the study?
Oxford VR/Nowican (UK)

Who is the main contact?
1. Polly Haselton
phaselton@oxfordvr.org
2. Prof. Daniel Freeman

Trial website

Contact information

Type

Public

Primary contact

Ms Polly Haselton

ORCID ID

Contact details

King Charles House
Park End Street
Oxford
OX1 1JD
United Kingdom
+44 (0)7388 872 383
phaselton@oxfordvr.org

Type

Scientific

Additional contact

Prof Daniel Freeman

ORCID ID

Contact details

Department of Psychiatry
Warneford Hospital
University of Oxford
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R52909/RE001

Study information

Scientific title

Using virtual reality (VR) to reduce fear of heights: a parallel-group, randomised controlled trial of a virtual reality cognitive behavioural therapy based programme for fear of heights

Acronym

Study hypothesis

The primary hypothesis is that the VR treatment, compared to a non-intervention control group, will reduce fear of heights at the end of treatment.
The secondary hypothesis is that the treatment gains will be maintained at follow-up.

Ethics approval

University of Oxford Medical Sciences Inter-Divisional Research Ethics Committee, ref: R52909/RE001

Study design

Parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Fear of heights

Intervention

Participants will be randomly allocated, stratified by fear of height severity and using randomised permuted blocks, to VR treatment or control (no treatment). The VR cognitive behavioural treatment for fear of heights is automated and is delivered in six sessions, typically lasting 20-30 minutes, over approximately a fortnight.

The outcomes are self-report assessments of fear of heights, with neither participant nor researcher blind to randomisation allocation, conducted at 0, 2 (post-treatment), and 4 weeks (a fortnight after treatment ends).

Updated 18/10/2017:
The outcomes are self-report assessments of fear of heights, with the researcher administrating the assessments blind to randomisation allocation, conducted at 0, 2 (post-treatment), and 4 weeks (a fortnight after treatment ends).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Fear of heights, assessed using the Heights Interpretation Questionnaire (Steinman and Teachman, 2011) at 0, 2 (post-treatment), and 4 weeks (a fortnight after treatment ends)

Secondary outcome measures

Fear of heights, assessed using the Acrophobia Questionnaire (AQ) (Cohen, 1977); Phobia Avoidance item 3 (IAPT, 2008) at 0, 2 (post-treatment), and 4 weeks (a fortnight after treatment ends)

Overall trial start date

01/05/2017

Overall trial end date

01/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (18+ years old)
2. Fear of heights (Heights Interpretation Questionnaire score of 30 or greater)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Current psychological treatment for fear of heights
2. Unable to travel to research appointments
3. Photosensitive epilepsy
4. Lack of stereoscopic vision or balance problems

Recruitment start date

01/11/2017

Recruitment end date

01/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford VR/Nowican
King Charles House Park End Street
Oxford
OX1 1JD
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials Research Governance
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Oxford VR/Nowican

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Submission of a paper to a peer-reviewed psychiatric/mental health journal in April 2018.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. The data will be held by Oxford VR.

Intention to publish date

01/04/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/10/2017: Interventions field updated.