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. 2020 Nov 2;2020(11):CD013287. doi: 10.1002/14651858.CD013287.pub2

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
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
Interventions
  • Extended SEI (n = 82) consisted of 1 additional year of SEI in patients that already underwent at least 2 years of SEI

    • components of treatment included

      • phase‐specific case‐management

      • caseload 1:80

      • relapse prevention

      • psychoeducation

  • SEI + TAU (n = 78) included outpatient medical follow‐up with limited community support

Outcomes
  • Recovery ‐ used remission as proxy ‐ recovery was defined according to the Remission in Schizophrenia Working Group based on the PANSS criteria of a PANSS score of less than 3 on questions P1 – P3, N1, N4 and N6, and G5 and G9 for six months

  • Disengagement ‐ if participants were no longer attending mental health treatment during the trial follow‐up

  • Admission to psychiatric hospital

  • Number of days in psychiatric hospital

  • General psychotic symptoms score ‐ PANSS

  • Positive psychotic symptoms score ‐ PANSS

  • Negative psychotic symptoms score ‐ PANSS

  • Depressive symptoms score ‐ CDS

  • Death via suicide or natural causes

  • General functioning score ‐ RFS

  • Employment or education status

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.
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