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

2. Suggested design for a new study.

Methods Allocation: randomised
Blinding: n/a. There is a very low likelihood of blinding being maintained in a such a complex intervention.
Duration: > 2 years intervention period, at least > 1‐year follow‐up period
Participants Diagnosis: psychosis and related diagnoses
N = 477*
Gender: men and women
Age: 14 to 65
Interventions Extended SEI comprised of continuation of SEI treatment combined with small caseload sizes (< 25), and inclusion of booster sessions of therapeutic intervention where indicated.
Outcomes Global state: recovery**
Global state: relapse
Service use: disengagement from services
Service use: admission to psychiatric hospital
Functioning: clinically important change in functioning
Quality of life: clinically important change in quality of life
Economics: cost of care
Notes * Sample size suggested relates to the size of a study with sufficient power to highlight a 10% difference between groups for the primary outcome
** Primary outcome

SEI: specialised early intervention