Psychosis Mental and Behavioural Disorders Psychosis
Conditions
Interventions
Study Entry: Single Randomisation only.
Participants will be randomly assigned on a 1:1 ratio to either the intervention (Actissist plus TAU) or control (ClinTouch plus TAU) groups.
Actissist intervention: Theoretically-informed content a
Follow-up: 12 weeks post randomisation and 24 weeks post randomisation
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/03/2018: 1. Meet ICD-10 criteria for a schizophrenia-spectrum diagnosis (ICD codes F20, F22, F23, F25, F28, F29) as confirmed by the treating clinician or Early Intervention for Psychosis Service entry criteria, operationally defined using the Positive and Negative Syndrome Scale (PANSS) and/or the psychosis transition criteria of the Comprehensive Assessment of At-Risk Mental States 2. In contact with mental health services 3. Within 5 years from onset of first psychotic episode, deemed by the treating clinician 4. Meet a criterion level of positive symptoms severity, indicated by a score of >3 (symptom present) on any PANSS positive item and a score of >3 (symptom present) on any PANSS negative or PANSS general items 5. English speaking 6. Aged 16 years or older 7. Capacity and willingness to provide informed consent 8. Not currently participating in another trial Previous inclusion criteria: 1. Early psychosis (within 5 years of initial episode), deemed by the treating clinician 2. In current contact with either an early intervention service or a secondary mental health service 3. PANSS total score 65 or more 4. English speaking 5. Aged 16 years or older 6. Capacity to provide informed consent 7. Not currently participating in another trial
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 20/03/2018: 1. Anyone with psychosis not in contact with a NHS mental health service 2. Anyone less than 16 years old at the point of recruitment 3. Anyone not capable of giving informed consent 4. Non-English proficient 5. Score <3 on all PANSS positive, negative and general items Previous inclusion criteria: 1. Anyone with psychosis not in contact with a NHS mental health service 2. Anyone less than 16 years old at the point of recruitment 3. Anyone not capable of giving informed consent 4. Non-English proficient 5. Score <65 on PANSS total 6. Current participation in another trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All outcomes measured at baseline, 12 weeks post randomisation, and 24 weeks post randomisation: 1. Symptom distress is measured using the Psychotic Symptoms Rating Scales (PSYRATS) 2. Mood is measured using the Calgary Depression Scale (CDSS) for Schizophrenia 3. Social functioning is measured using the Personal and Social Performance Scale (PSP) 4. Perceived criticism and perceived warmth is measured using the Perceived Criticism and Perceived Warmth Scale (PCPW) 5. Recovery is measured using the Questionnaire about the Process of Recovery (QPR) 6. Well-being is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWEBS) 7. Internalised stigma is measured using the Internalised Stigma of Mental Illness Inventory (ISMI) 8. Cannabis use frequency is measured using the Time Line Follow Back for drugs and alcohol (TLFB) and the DUDIT/DUDIT-E 9. Empowerment is measured using the Empowerment Scale (ERS) 10. Health economics is measured using Euro-Qol Five Dimension (EQ-5D-5L) and Client Service Receipt Inventory (CSRI) Updated 20/03/2018: 8. Substance use is measured using the Alcohol Use Disorders Inventory (AUDIT; past 3 months), Cannabis Use Disorders Inventory-Revised (CUDIT-R; past 3 months), Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), Drug Use Disorder Identification Test-Extended (cannabis only). Cannabis use frequency is measured using the Time Line Follow Back for drugs and alcohol (TLFB) | — |
Primary
| Measure | Time frame |
|---|---|
| Psychotic symptoms are measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, 12 weeks post randomisation and 24 weeks post randomisation Updated 23/04/2018: The primary outcome will be determined at the 12-week (post-randomisation) follow-up timepoint | — |
Countries
England, United Kingdom
Contacts
Public ContactAlyson Williams
Outcome results
None listed