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