Psychosis Mental and Behavioural Disorders
Conditions
Interventions
Current interventions, as of 23/05/2025:
We aim to recruit 1100 relapse-prone individuals with a schizophrenia spectrum diagnosis. To achieve our objectives, we will recruit one cohort (data will be
we will simply use the data collected to test the algorithm.
This design of derivation/internal validation and subsequent temporal validation is appropriate to assess the algorithm’s validity. Group
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/05/2025: Participants will be people with lived experience of psychosis on existing caseloads of secondary care mental health teams in NHS Trusts/Health Boards who are: 1. Adults of working age (16+ years) 2. Within the past 2 years have had at least one acute episode of psychosis (including relapse and first episode) leading to an unscheduled episode of acute care, including inpatient admission or acute home treatment/crisis intervention 3. Received a clinical diagnosis of, or confirmed by the treating clinician to meet the criteria of, schizophrenia spectrum disorder (ICD10 F20 - 29) 4. Current presentation does not include severe acute symptoms 5. In accordance with the Mental Capacity Act, mental capacity will be assumed. If there is any doubt, then a capacity assessment will be carried out by a clinician from the study team or the responsible clinician _____ Previous inclusion criteria: Participants will be people with lived experience of psychosis on existing caseloads of secondary care mental health teams in NHS Trusts/Health Boards who are: 1. Adults of working age (16+ years) 2. Within the past 2 years have had at least one acute episode of psychosis (including relapse and first episode) leading to an unscheduled episode of acute care, including inpatient admission or acute home treatment/crisis intervention 3. Received a clinical diagnosis of schizophrenia spectrum disorder (ICD10 F20 - 29) 4. Current presentation does not include severe acute symptoms 5. In accordance with the Mental Capacity Act, mental capacity will be assumed. If there is any doubt, then a capacity assessment will be carried out by a clinician from the study team or the responsible clinician
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/05/2025: 1. Experienced a recent relapse within the previous 12 weeks as confirmed by the treating clinician 2. Non-English speaking _____ Previous exclusion criteria: 1. Experienced a recent relapse, operationally defined as having been discharged from the care of a crisis team/psychiatric inpatient service within the previous 12 weeks 2. Non-English speaking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 30/12/2025: Relapse within 12 months of entering the study measured using patient records defined as: 1. A return or exacerbation in psychotic symptoms of at least moderate degree OR, 2. A return or exacerbation of cognition / disorganisation of at least a moderate degree, AND, 3. Where symptoms have lasted at least one week in duration AND, 4. Where there is evidence of a decline in functioning OR an increase in risk to self or others AND, 5. There is evidence of an escalating clinical response from services. Previous primary outcome: Relapse within 12 months of entering the study measured using patient records defined as: 1. A return or exacerbation in psychotic symptoms of at least moderate degree OR, 2. A return or exacerbation of affective symptoms of at least a moderate degree, OR, 3. A return or exacerbation of cognition / disorganisation of at least a moderate degree, OR, 4. A return or exacerbation of excitement of at least a moderate degree, AND 5. Where symptoms have lasted at least one week in duration AND, 6. Where there is evidence of a decline in functioning OR an increase in risk to self or others AND, 7. There is evidence of an escalating clinical response from services. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/05/2025: Measured at baseline, 4, 8 and 12 months: 1. Mental Health Status - Clinical Global Impression-Schizophrenia scale and Psychotic Symptom Rating Scales (PSYRATS) distress and frequency scale 2. Emotional Distress - Calgary Depression Scale, Fear of Recurrence Scale, Work and Social Adjustment Scale, Criticism and Warmth Scale, Dunn Worry Questionnaire, General Anxiety Disorder Questionnaire, EQ-5D-5L 3. Substance misuse - Alcohol, Smoking and Substance Involvement Screening Test – LITE (ASSIST-LITE) 4. Service use & clinical relapse - Captured from the medical record, Medication Adherence Rating scale 5. Technology use - Self-reported acceptability and usability using Post-Study System Usability Questionnaire (measured at 4, 8 and 12 months only) _____ Previous secondary outcome measures: Measured at baseline, 3, 6, 9 and 12 months: 1. Mental Health Status - Clinical Global Impression-Schizophrenia scale and Psychotic Symptom Rating Scales (PSYRATS) distress and frequency scale 2. Emotional Distress - Calgary Depression Scale, Fear of Recurrence Scale, Work and Social Adjustment Scale, Criticism and Warmth Scale, Dunn Worry Questionnaire, General Anxiety Disorder Questionnaire, EQ-5D-5L 3. Substance misuse - Alcohol, Smoking and Substance Involvement Screening Test – LITE (ASSIST-LITE) 4. Service use & clinical relapse - Captured from the medical record, Medication Adherence Rating scale 5. Technology use - Self-reported acceptability and usability using Post-Study System Usability Questionnaire (measured at 3, 6, 9 and 12 months only) | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed