The THRIVE study: a randomized controlled trial comparing Virtual Reality Confidence Building with VR Mental Relaxation for people with fears about others

niversity of Oxford0 个研究点目标入组 80 人开始时间: 2018年8月14日最近更新: 2023年10月9日

适应症

试验速览

•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)

•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).

发起方