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Automated virtual reality (VR) cognitive therapy for patients with psychosis: study protocol for a single-blind parallel group randomised controlled trial (gameChange)
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  • Published on:
    Protocol alteration: change of primary outcome measure due to the pandemic
    • Daniel Freeman, Professor of Clinical Psychology and gameChange Chief Investigator University of Oxford
    • Other Contributors:
      • Ariane Petit, Trial co-ordinator
      • Ly-Mee Yu, Associate Professor and Deputy Director Academic (Primary Care Clinical Trials Unit). gameChange trial lead statistician

    The original primary outcome

    The gameChange trial primary outcome was avoidance and distress in real-life situations measured using a behavioural assessment task (Oxford-Behavioural Assessment Task, O-BAT). The O-BAT is administered with a trial research assistant and the patient is asked to go into a (personalised) hierarchy of five real world situations that they find anxiety-provoking (e.g. go into a local café or shop). The assessment records how many of the five steps the individual completed (avoidance score) and their level of anxiety (distress score).

    Why the measure had to be changed

    Due to the COVID-19 lockdown measures implemented in March 2020, we were not allowed to administer the O-BAT. It would involve face-to-face contact, which was prohibited by the NHS trusts. It was also the case that many locations (e.g. cafes, shops) used in the O-BAT were closed. All patient recruitment into the trial was suspended for six months but remote assessments continued for those who had already entered into the trial.

    The replacement primary outcome

    We had already developed a self-report version of the O-BAT, which was a secondary outcome measure. In the published protocol this is called the ‘self-report O-BAT’. We now call the measure the Oxford Agoraphobic Avoidance Scale (O-AS) (Lambe et al, submitted). We have made this self-report version of the O-BAT the primary outcome variable. As in the original O-BAT, the O-AS gives an avoidance...

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    Conflict of Interest:
    DF is a founder and non-executive board director of Oxford VR, a University of Oxford spin-out company, which has programmed the gameChange treatment and will commercialise it.