The gameChange trial
Research type
Research Study
Full title
The gameChange Trial: A randomised controlled trial testing automated virtual reality cognitive therapy for patients with fears in everyday social situations.
IRAS ID
256895
Contact name
Daniel Freeman
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN17308399
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
Many patients with psychosis find it frightening or difficult to be in everyday social situations. This fear leads patients to withdraw, and this leads to a cycle of worsening physical and mental health. Breaking this cycle requires highly active treatment that enables patients to learn that they can safely and confidently enter everyday situations using in vivo direct coaching. However patients with psychosis seldom receive these life-changing interventions.
To solve this problem we have developed an automated psychological treatment using Virtual Reality (VR). VR allows the individual to repeatedly experience simulations of the situations they find difficult. A virtual coach helps patients overcome their fears. Patients are more willing to go into VR simulations because they know that they are not real but the learning still transfers to the real world. With people with lived experience, psychologists, designers, and programmers, we have developed a new six session VR cognitive treatment to help patients overcome fears in everyday social situations. The VR treatment includes engaging tasks that maximise learning of safety. We will test this treatment in a randomised controlled trial.
The trial will determine the clinical effectiveness of an automated VR treatment for patients with psychosis.
432 psychosis patients and having anxieties going outside will be randomised (1:1) to the VR cognitive treatment added to treatment as usual or treatment as usual. Blind assessments will be conducted at 0, 6 (post treatment), and 26 weeks. The primary outcome is distress and avoidance of real-life situations (using a behavioural assessment task). The secondary outcomes are activity levels, psychiatric symptoms, and quality of life. Mediation will also be tested. All analyses will be intention-to-treat. An economic evaluation will assess cost-effectiveness and there will be a process evaluation.
The trial is funded by the National Institute of Health Research invention 4 innovation (i4i) programme.
Summary of Results
Our goal was to discover whether gameChange helps people to feel calmer and more confident in everyday situations. 346 people who found everyday activities difficult with anxiety participated.
The study
Half the participants received gameChange VR therapy (in addition to their usual care) and half simply continued their usual care.VR therapy usually involved six sessions, each lasting an hour. Whether a person had the VR therayp was decided at randon by a computer.
Everybody met with a research assistant at the beginning of the study, after six weeks, and after six months. This was to see whether their anxiety had changed.
The results
The study showed that gameChange was generally helpful in reducing anxiety in everyday situations.The people who found it most beneficial were usually those who had experienced the most challenging problems because of anxiety - for example, people who had found it hard to leave the house on their own. These benefits were still present six months later.
The treatment worked by reducing the anxiosu thoughts and behaviours that prevent people from learning that they are safe. People usually enjoyed the gameChange experience and found it easy to use.
What happens next
The study results have been published in the Lancet Psychiatry, which means other mental health professionals will learn about gameChange.We are currently in discussion with the NHS about making gameChange widely available. We also want to try to see whether we can improve gameChange so that it helps even more people.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0075
Date of REC Opinion
29 Apr 2019
REC opinion
Further Information Favourable Opinion