Condition category
Mental and Behavioural Disorders
Date applied
01/05/2019
Date assigned
02/05/2019
Last edited
02/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Many patients with psychosis experience everyday social situations as anxiety-provoking. The fears can arise, for example, from paranoia, hallucinations, social anxiety, or negative self-beliefs. The fears lead patients to withdraw from activities, and this isolation leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment directly in troubling situations so that patients learn that they can safely and confidently enter them. However, patients with psychosis seldom receive such life-changing interventions. To solve this problem researchers have developed an automated psychological treatment delivered in Virtual Reality (VR). It allows patients to experience computer simulations of the situations that they find anxiety-provoking (e.g. a street, a shop, a café, a GP surgery). A virtual coach guides patients, using cognitive techniques, in how to overcome their fears. Patients are willing to enter VR simulations of anxiety-provoking situations because they know the simulations are not real, but the learning made still transfers to the real world. The aim of the study is to test whether the automated VR therapy works (i.e. reduces anxiety and avoidance of social situations).

Who can participate?
Patients with psychosis attending NHS mental health trust services who get anxious in everyday social situations.

What does the study involve?
Participants are randomly allocated to the automated VR cognitive treatment added to treatment as usual, or treatment as usual. The VR treatment comprises about six 30-minute (half an hour) sessions. Assessments are conducted at the start of the study and after 6 and 26 weeks to measure avoidance and distress in real-life situations, psychiatric symptoms, activity levels, and quality of life.

What are the possible benefits and risks of taking part?
It is hoped that the automated VR therapy will enable people to be much more confident about everyday social situations. There are no notable risks of taking part.

Where is the study run from?
Oxford Health NHS Foundation Trust/University of Oxford. There are also trial sites at Bristol, Newcastle, Nottingham, and Manchester (UK)

When is the study starting and how long is it expected to run for?
June 2018 to May 2021

Who is funding the study?
National Institute for Health Research (NIHR), Invention for Innovation programme (i4i) (UK)

Who is the main contact?
Prof. Daniel Freeman
Daniel.freeman@psych.ox.ac.uk

Trial website

https://gamechangevr.com/

Contact information

Type

Scientific

Primary contact

Prof Daniel Freeman

ORCID ID

http://orcid.org/0000-0002-2541-2197

Contact details

Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865613109
daniel.freeman@psych.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2.1

Study information

Scientific title

Automated virtual reality (VR) cognitive therapy for patients with psychosis who have anxious avoidance of social situations: a single-blind parallel group randomised controlled trial (gameChange)

Acronym

gameChange

Study hypothesis

The primary research question we will test is: Does automated VR cognitive treatment (the gameChange VR therapy) added to treatment as usual, compared to treatment as usual alone, lead to a post-treatment reduction in real-world avoidance and distress for patients with psychosis attending NHS mental health services?

The primary hypothesis is that compared to treatment as usual, VR cognitive therapy added to treatment as usual will reduce avoidance and distress of real-world situations (post-treatment).

Ethics approval

Approved 29/04/2019, NHS Health Research Authority (HRA) South Central - Oxford B Research Ethics Committee (Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT; Tel: +44 (0)207 104 8168; Email: nrescommittee.southcentral-oxfordb@nhs.net), ref: 19/SC/0075

Study design

Multicentre parallel-group randomised controlled trial with single-blind assessment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Clinical diagnosis of schizophrenia spectrum psychosis (F20-29) or an affective diagnosis with psychotic symptoms (F31.2, 31.5, 32.3, 33.3) (ICD-10, WHO, 2010); self-reported difficulties going outside the home primarily due to anxiety

Intervention

Participants are randomised (1:1) to the automated VR cognitive treatment added to treatment as usual or treatment as usual.

The gameChange VR treatment is a virtual-reality application recommended for adults (16+) who have anxieties when outside in everyday social situations. This software is intended to reduce anxieties around other people and therefore to help participants feel safer and more comfortable around people. The aim for the outcome is that patients feel more able to go outside into everyday situations. The treatment was programmed by the University of Oxford spin-out company, Oxford VR (www.oxfordvr.org). The treatment is a CE marked Class I Active Medical Device (Standalone Software).

The VR Cognitive Therapy (VRCT/gameChange treatment) aims for patients to test their fear expectations around other people in order to relearn safety. The treatment is not designed as exposure therapy (participants are not asked to remain in situations until anxiety reduces) but as repeated behavioural experiment tests (to learn that they are safer than they had thought). The treatment is designed to be delivered in approximately 6 sessions of thirty minutes. Three sessions will be considered the minimum (adherent) dose of therapy. However, participants can proceed at their own pace, meaning that a fewer or greater number of sessions is allowed. The participant typically stands, and is able to walk a few paces in the scenarios. A virtual coach guides the person through the treatment, including encouraging the dropping of defence behaviours, and elicits feedback to tailor the progression of the treatment. When first entering VR, the patient is guided in a calm VR space how to use VR (i.e. the basic functions). They then go into the coach’s virtual office. At the beginning of the first session, the virtual coach explains the rationale behind the treatment, and the participant selects which one of six virtual reality situations that they would like to begin in. The six virtual reality scenarios are a: café, GP waiting room, pub, bus, street scene, and newsagent. Each scenario has five degrees of difficulty (e.g. the number and proximity of people in the social situation increases) and participants work their way through each level of difficulty. There are game type tasks within a number of the levels. The participant can choose a different scenario in each session or repeat a previous situation. Throughout the sessions, participants’ responses to questions from the virtual coach are given by means of gripping a virtual globe. Belief ratings are repeated within VR at the end of each treatment session.

Assessments will be conducted at 0, 6 (post-treatment), and 26 weeks by a researcher blind to allocation. The primary outcome is avoidance and distress in real-life situations, using a behavioural avoidance task, at six weeks. The secondary outcomes are psychiatric symptoms, activity levels, and quality of life. Primary analysis will be intention-to-treat. The researchers will also examine how the treatment works. An economic evaluation will be conducted.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Avoidance and distress in real-life situations, measured using Oxford - Behavioural Avoidance Task (O-BAT) at 0, 6 and 26 weeks (primary outcome timepoint 6 weeks)

Secondary outcome measures

1. Anxious avoidance assessed with the AMI-A (Chambless et al., 1985) and the self-report O-BAT (Lambe et al, in prep) at 0, 6, 26 weeks
2. Activity levels measured by actigraphy at 0, 6, 26 weeks
3. Personal recovery measured with the Questionnaire about the Process of Recovery (QPR) (Neil et al., 2009) at 0, 6, 26 weeks
4. Paranoia measured with the R-GPTS (Green et al, 2008; Freeman et al, in prep) at 0, 6, 26 weeks
5. Worries with paranoid content measured with the Paranoia Worries Questionnaire (Freeman et al, 2019) at 0, 6, 26 weeks
6. Depression measured with the PHQ-9 (Kroenke et al, 2001) at 0, 6, 26 weeks
7. Suicidal ideation measured with the Columbia Scale Severity Scale (Posner et al, 2011) at 0, 6, 26 weeks
8. Meaningful activity measured with the time-budget (Jolley et al, 2006) at 0, 6, 26 weeks
9. Quality of life measured with the EQ-5D-5L (http://www.euroqol.org/) and ReQol (Keetharuth et al, 2018) at 0, 6, 26 weeks
10. Health economics measured with the Client Service Receipt Inventory (Beecham and Knapp, 1992) at 0, 6, 26 weeks

Overall trial start date

01/06/2018

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults aged 16 years or older
2. Attending a NHS mental health trust for the treatment of psychosis
3. Clinical diagnosis of schizophrenia spectrum psychosis (F20-29) or an affective diagnosis with psychotic symptoms (F31.2, 31.5, 32.3, 33.3) (ICD-10, WHO, 2010)
4. Having self-reported difficulties going outside their home primarily due to anxiety that they would like treated
5. Participant is willing and able to give informed consent for participation in the trial

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

432

Participant exclusion criteria

1. Unable to attempt an Oxford-Behavioural Assessment Task (O-BAT) (the primary outcome measure) at baseline (e.g. due to being unpermitted to leave a psychiatric ward)
2. Photosensitive epilepsy
3. Significant visual, auditory, or balance impairment
4. Current receipt of another intensive psychological therapy (or about to start it within the 6-week trial therapy window)
5. Insufficient comprehension of English
6. In forensic settings or Psychiatric Intensive Care Unit (PICU)
7. Organic syndrome
8. Primary diagnosis of alcohol or substance disorder or personality disorder
9. Significant learning disability
10. Current active suicidal plans

Recruitment start date

01/07/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
Warneford Hospital Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Foundation Trust
The Resource Trust HQ Duncan Macmillan House Porchester Road
Nottingham
NG3 6AA
United Kingdom

Trial participating centre

Northumberland, Tyne, and Wear NHS Foundation Trust
St. Nicholas Hospital Jubilee Road Gosforth
Newcastle Upon Tyne
NE3 3XT
United Kingdom

Trial participating centre

Avon and Wiltshire Mental Health Partnership NHS Trust
Jenner House Avon Way Langley Park
Chippenham
SN15 1GG
United Kingdom

Trial participating centre

Greater Manchester Mental Health NHS Foundation Trust
Prestwich Hospital Bury New Road Prestwich
Manchester
M25 3BL
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX37LQ
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

https://researchsupport.admin.ox.ac.uk/ctrg

Funders

Funder type

Government

Funder name

Invention for Innovation Programme

Alternative name(s)

NIHR Invention for Innovation Programme, i4i

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial protocol will be submitted for publication before the start of the trial. The outcome results, and tests of moderation, mediation, and cost-effectiveness, will be reported in scientific journals and conference presentations.

IPD sharing statement
All requests for access to the trial data after the publication of the main outcome data will be considered by the trial team. Please contact Prof. Daniel Freeman (daniel.freeman@psych.ox.ac.uk).

Intention to publish date

01/09/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/05/2019: Trial's existence confirmed by South Central - Oxford B Research Ethics Committee.