Persecutory delusion Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Current intervention as of 28/04/2021:
The trial is for people who have a persecutory delusion
specifically, that they feel threatened when with other people. It is a parallel group randomised controlled trial (i.e. each person has a 50% chance of being randomly allocated to receive one of two
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: 1. Real world distress assessed by a brief behavioural test (added 01/04/2021: O-BAT) ; Timepoint(s): Assessed at 0 and 4 weeks 2. Overall paranoia assessed using the Revised Green Paranoid Thoughts Scale (Revised-GPTS); Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks 3. Delusion severity assessed by the PSYRATS; Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks 4. Suicide ideation assessed by the Columbia-Suicide Severity Rating Scale; Timepoint(s): Assessed at 0, 4, and 24 weeks 5. Activity levels assessed using actigraphy and a time-budget measure; Timepoint(s): Assessed at 0, 4, and 24 weeks 6. Quality of life assessed by the EQ-5D-5L; Timepoint(s): Assessed at 0, 4, and 24 weeks 7. Wellbeing assessed by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and the Questionnaire about the Process of Recovery (QPR); Timepoint(s): Assessed at 0, 4, and 24 weeks 8. Service use recorded using questions from the Client Service Receipt Inventory; Timepoint(s): Assessed at 0 and 24 weeks 9. Defence behaviours assessed using the Safety Behaviours Questionnaire; Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks 10. Strength of safety beliefs assessed using visual analogue scales; Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks _____ Previous secondary outcome measures: 1. Real world distress assessed by a brief behavioural test (added 01/04/2021: O-BAT) ; Timepoint(s): Assessed at 0 and 4 weeks 2. Overall paranoia assessed using the Green Paranoid Thoughts Scale (GPTS); Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks 3. Delusion severity assessed by the PSYRATS; Timepoint(s): Assessed at 0, 2, 4, 8, 16, and 24 weeks 4. Suicide ideation assessed by the C | — |
Countries
England, United Kingdom
Outcome results
None listed