Psychosis Mental and Behavioural Disorders
Conditions
Interventions
Participants who meet the inclusion criteria will be randomly allocated to either PITp plus treatment as usual (TAU) or TAU alone. We will randomise participants at the individual level using an indep
Sponsors
Greater Manchester Mental Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older 2. Attending NHS mental health services for the treatment of psychosis 3. Willing and able to provide written, informed consent for participation in the trial 4. Help-seeking (defined as identifying a current difficulty or concern for which the individual wishes to receive therapeutic help, as opposed to enrolling primarily for non-therapeutic reasons such as contributing to research) 5. No planned significant medication changes at the outset of participation
Exclusion criteria
Exclusion criteria: 1. Primary diagnosis of another mental health condition (e.g., substance use disorder) that would be the first clinical priority to treat. 2. Current engagement in any other intensive individual psychological therapy or significant change in medication. 3. In forensic settings, Psychiatric Intensive Care Units (PICU) or currently admitted to an acute psychiatric inpatient ward (Note: Individuals residing on longer-term rehabilitation wards are eligible to participate, provided they meet the study inclusion criteria). 4. Command of spoken English inadequate for engaging in the therapy. 5. Significant learning difficulties that would prevent the completion of assessments or the therapy. 6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to be the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. The reason for exclusion will be recorded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility assessed over the study period: 1. Recruitment rate, measured as the number of eligible participants who consent (target n = 40) 2. Retention rate, measured as the proportion of randomised participants completing the 6-month follow-up 3. Intervention uptake, measured as the proportion of PITp-allocated participants receiving =6 therapy sessions within 6 months 4. Acceptability of randomisation, measured as the proportion of consented participants agreeing to randomisation 5. Completion rates of outcome measures at baseline and 6 months 6. Acceptability of PITp, assessed via semi-structured qualitative interviews informed by the Theoretical Framework of Acceptability at the end of intervention delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at baseline and 6 months: 1. Psychotic symptoms assessed using the Psychotic Symptoms Rating Scale (PSYRATS): Multi-modal Hallucinations (PSYRATS-MMH) 2. Paranoia assessed using the Revised Green et al. Paranoid Thoughts Scale (R-GPTS) 3. Personal recovery assessed using the Questionnaire about the Process of Recovery (QPR) – 15 4. Quality of life assessed using the Recovering Quality of Life (ReQoL-10) 5. Emotional processing assessed using the Emotional Processing Scale (EPS-25) 6. Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) 7. Anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7) 8. Interpersonal problems assessed using the Inventory of Interpersonal Problems-32 (IIP-32) 9. Health-related quality of life assessed using EQ-5D-5L 10. Health and social care resource use assessed using electronic medical records 11. Therapeutic alliance (intervention arm only) assessed using the Working Alliance Inventory – Short Revised (WAI-SR) 12. Safety: adverse events and serious adverse events recorded throughout participation | — |
Countries
England, United Kingdom
Contacts
Public ContactLiz Murphy
Outcome results
None listed