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gameChange VR: automated virtual therapy to help patients with psychosis reduce anxious avoidance of everyday situations

gameChange VR: a real-world waitlist randomised controlled trial for the treatment of severe agoraphobic avoidance in the context of psychosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79060696
Enrollment
200
Registered
2025-04-09
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agoraphobic avoidance (severe) in patients with a diagnosis of psychosis Mental and Behavioural Disorders

Interventions

UKCA marked gameChange VR therapy. Guided provision of VR therapy for 8 weeks. Delivery supported by a mental health staff member (e.g, peer support worker, assistant psychologist, therapist). gamecha

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Attending NHS or commissioned Voluntary, Community and Social Enterprise (VCSE) mental health services. 2. Clinical diagnosis of schizophrenia spectrum psychosis or an affective diagnosis with psychotic symptoms 3. Severe agoraphobic avoidance as assessed by the Oxford Agoraphobic Avoidance Scale (score of 6 or above) and wanting help for that difficulty

Exclusion criteria

Exclusion criteria: 1. Photosensitive epilepsy. 2. In forensic settings or Psychiatric Intensive Care Unit. 3. Command of spoken English inadequate for engaging in the therapy or assessments. 4. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to be the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. Reason for exclusion will be recorded.

Design outcomes

Primary

MeasureTime frame
Agoraphobic avoidance is measured using the Oxford Agoraphobic Avoidance (O-AS) – avoidance subscale at baseline, 8 weeks, 26 weeks. (This will be measured additionally at 34 weeks for the wait-list control group i.e. after they have received the treatment.) The primary endpoint for this outcome is 26 weeks.

Secondary

MeasureTime frame
1. Agoraphobic avoidance (distress level) is measured using the Oxford Agoraphobic Avoidance Scale (O-AS) – distress subscale at baseline, 8 weeks, and 26 weeks. (This will be additionally measured at 34 weeks for the control group.) 2. Paranoia is measured using the Revised Green et al Paranoid Thoughts Scale at baseline, 8 weeks, and 26 weeks. (This will be additionally measured at 34 weeks for the control group.) 3. Number of social contacts is measured using the Social Contact Assessment at baseline, 8 weeks, and 26 weeks. (This will be additionally measured at 34 weeks for the control group.) 4. Treatment acceptability is measured using the Theoretical Framework of Acceptability (TFA) at 8 weeks for the intervention group. (This will also be measured at 34 weeks for the control group after they have had the VR treatment.) 5. VR side effects will be measured using the Oxford – VR Side Effects Checklist at 8 weeks for the intervention group. (This will also be measured at 34 weeks for the control group after they have had the VR treatment.) 6. Occurrence of serious adverse events will be checked using medical notes (in addition to any patient reports) over 0-26 weeks. (Notes will also be checked for the period 26-34 weeks for the control group.)

Countries

England, United Kingdom

Contacts

Public ContactDaniel Freeman
daniel.freeman@psy.ox.ac.uk+44 1865223635

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026