Virtual reality treatment for building confidence around people

Not Applicable

Completed

• Conditions: Persecutory delusion; Mental and Behavioural Disorders; Schizophrenia

• Registration Number: ISRCTN12497310
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30696471 protocol 2023 Results article in https://doi.org/10.1016/s2215-0366(23)00257-2 (added 25/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-14
• Study Completion: 2021-12-31
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the trial
2. Male or female, aged 16 years or above
3. Persistent (at least 3 months) persecutory delusion (as defined by Freeman & Garety, 2000), held with at least 50% conviction; specifically, participants will be reporting feeling threatened when with other people
4. Primary diagnosis of schizophrenia-spectrum psychosis (non-affective psychosis)

Exclusion Criteria

1. Primary diagnosis of alcohol or substance disorder
2. Photosensitive epilepsy
3. Significant visual, auditory, or balance impairment
4. Current receipt of another psychological therapy
5. Insufficient comprehension of English
6. In forensic settings
7. Organic syndrome
8. Learning disability
9. Current active suicidal plans
10. Any other factor, 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 in line with CONSORT guidelines.

Added 01/04/2021:
When ethical approval was received on 07/09/2020 to restart the trial following the pause due to COVID-19, this was with a continuing recruitment suspension in place for participants who were at moderate or high risk for a severe course of COVID-19. From 05/02/2021 patients who were at moderate or high risk for a severe course of COVID-19 could join the trial if they had received the COVID-19 vaccine (subject to medical advice).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conviction in the persecutory delusion, measured using a 0–100% scale; Timepoint(s): This is assessed at 0, 2, 4, 8, 16, and 24 weeks. The primary endpoint is 4 weeks.