EASY_Extended.
Study characteristics | ||
Methods | Study design: individually‐RCT Duration: 12 months extension of SEI + 12‐month post‐treatment follow‐up. Two‐year duration standard SEI (prior to trial) is followed by one‐year extension of ESEI (in intervention arm), and a one‐year follow‐up. Total SEI plus ESEI duration was three years Setting: community‐based mental health team, Hong Kong Recruitment method: patients who had received two years of the standard EASY programme following their first episode of psychosis |
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Participants | Diagnosis: the majority were schizophrenia spectrum disorders (84% in extended SEI arm and 80% in SEI + TAU arm) Sample size: 160 participants randomised Age: mean age of onset of psychosis of 20.3 (SD = 3.1) Sex: 50% male and 51% male in extended SEI, and standard SEI + TAU, respectively Inclusion criteria: received 2 years of treatment in the EASY programme following a first episode of psychosis Exclusion criteria: intellectual disability, substance‐induced psychosis, psychotic disorder due to a general medical condition or an inability to speak Cantonese Chinese for the research interview |
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Interventions |
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Outcomes |
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Notes | Funding source: the study was supported by a grant from the Commissioned Research on Mental Health Policy and Services (SMH‐29) of the Food and Health Bureau, Government of Hong Kong Special Administrative Region Author Conflicts of Interest: EYHC has been a member of the paid advisory board for Otsuka and has received educational grant support from Janssen‐Cilag, Eli Lilly, Sanofi‐Aventis and Otsuka. EHML has been a member of the paid advisory boards for Eli Lilly and AstraZeneca. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation sequence. Quote: "An allocation sequence was computer‐generated with a fixed block size of four". |
Allocation concealment (selection bias) | Low risk | Randomisation carried out by an independent staff member. Quote: "Randomisation and concealment procedures were conducted by an independent research staff member who was not involved in recruitment, clinical management or research assessment of the study participants" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded. While the primary outcome measure was subjective, the outcome assessors were blind to treatment allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research assistant carrying out assessment was masked to allocation group. Quote: "Trained research assistants masked to treatment allocation administered all assessments". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data balanced in numbers across groups (3 lost from extended SEI, 1 from SEI + TAU) with similar reasons for leaving. Intention to treat analysis carried out using a linear mixed model. |
Selective reporting (reporting bias) | Low risk | Outcomes reported as in registry |
Other bias | Low risk | None detected |