Schizophrenia, schizotypal and delusional disorders Mental and Behavioural Disorders
Conditions
Interventions
iMAPS-2 involves novel change techniques including imagery re-scripting (imaging an image or memory and changing the ending to change the meaning) of past events, imagery re-scripting of flash-forward
Sponsors
Pennine Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Meeting criteria for a schizophrenia-spectrum diagnosis (ICD-10 codes F20, F22, F23, F25, F28, F29; ICD-11 codes F20, F22, F23, F25, F28, F29; ICD-11 codes 6A20, 6A21, 6A23, 6A24, 6A2Y,6A2Z) AND Score of 3 Mild or above on P1 Delusions or P3 Hallucinations on Positive and Negative Syndrome Scales (PANSS), OR a criterion level of positive symptoms severity indicated by a score of > 3 (mild symptom present) on the delusions (P1), hallucinations (P3), grandiosity (P5) or suspiciousness (P6) items of the PANSS in the previous week (this is usually the operational criteria to under the care of early intervention psychosis team) And/or the psychosis transition criteria of the CAARMS 2. Aged 18 years and above 3. Identifying a distressing image (Rated 50% distressing or above) related to the psychotic experience scoring 3 or above on PANSS. The participant will self-report the image as distressing (e.g., Have you had a distressing image over the past month? Yes/No What would you rate the distress over the past month from 0-100?). 4. Capacity to give informed consent, 5. Under the care of an NHS mental health team the study is recruiting from 6. With a keyworker/access to a duty team worker. Qualitative study: 1. Capacity to provide informed consent for interviews 2. Consent to have interviews recorded 3. Participation in iMAPS-2, with at least 4 weeks involvement in iMAPS-2 post randomisation 4. Sufficient English language proficiency to take part in qualitative interviews or agreement to the use of an interpreter Clinician referrers qualitative Study: 1. Consent to have interviews digitally recorded 2. Experience of referring at least one service user to the iMAPS-2 Study
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of alcohol, substance misuse disorder, or bipolar disorder (affective psychosis) 2. Secondary presenting difficulties such as severe addiction, acute suicidal risk, dementia, neurological disorder. 3. Developmental disability (moderate to severe learning difficulty) 4. Acquired brain injury/organic syndrome 5. Currently participating in physical or mental health treatment studies or receiving psychological therapy 6. Unable to complete the measures in written English (due to assessment battery psychometric validation in English) 7. In forensic settings 8. Unmanageable level of risk of violence to researchers or clinicians (harassment behaviour – stalking).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed after completion of 0, 16- and 28-weeks battery assessment follow ups by calculating: 1. Recruitment rate: number of participants consented into the trial and randomised. This will also include number of referrals per month; source of recruitment; number of patients (potential) participants contacted; number of participants screened for eligibility; number of screened patients who are found to eligible, reasons for non-eligibility or withdrawal of interest – where potential participants are happy to share these reasons). 2. Therapy engagement: i) Number of therapy sessions attended, ii) % of participants who drop out of therapy, iii) % of participants who did not receive treatment allocated. 3. Therapist adherence to therapy protocols and supervision protocols. This will include assessing therapist fidelity against the Cognitive Therapy Rating Scale Revised (CTS-R) or the Cognitive Therapy Rating Scale for Psychosis (CTS-Psy) 4. Therapy safety: number of Serious Adverse Events (SAEs) and Adverse Events (AEs) 5. Retention rates and Blinding Breaks | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 16 and 28 weeks: 1. Schema (Brief Core Schema Scales; Fowler, Freeman, Smith, Kuipers, Bebbington, Bashforth, et al., 2006) 2. Imagery characteristics (VAS/MIPQ; Taylor et al., 2019, PIQ; Taylor et al., 2022) 3. Psychosis (Psychotic Symptom Rating Scales; PSYRATS; Haddock et al., 1999, PANSS; Kay et al. 1987; QPR; Law et al., 2014) 4. Trauma (TALE; Carr et al., 2018, ITQ; Cloitre et al., 2018) 5. Basic Emotions Scale (Power, 2006) 6. Working alliance (WAI-Client/WAI-Therapist; Hatcher & Gillaspy, 2006) 7. EQ-5D 5L, a NICE recommended health measure utilised for QALY estimate and the ReQoL-10 for feasibility of economic analysis. 8. Health economic data, using an adapted version of the Economic Patient Questionnaire (Davies, Lewis and Jones, 2007) which includes questions from the Client Service Receipt Inventory (CSRI). 9. NHS service use measured by inpatient admission, outpatient visits, A&E, primary, community and social care use. 10. Mental health & functioning (BAI; Beck et al., 1988, CDS; Addington et al., 1993, WEMWBS; Tennant et al., 2007, PSP; Morosini et al., 2000) | — |
Countries
England, United Kingdom
Outcome results
None listed