Objective
This study seeks to determine the effectiveness of a comprehensive first-episode service (the clinic for Specialized Treatment Early in Psychosis, STEP) based in an urban U.S. community mental health center, compared to treatment as usual.
Methods
This pragmatic randomized controlled trial enrolled 120 ‘first-episode psychosis’ patients within 5 years of illness onset and 12 weeks of antipsychotic exposure. Referrals were mostly from area inpatient psychiatric units and enrollees were randomly allocated to STEP or referral to routine care (TU). Main outcomes included hospital utilization (primary), ability to work, attend age-appropriate schooling or actively seek these opportunities (‘vocational engagement’), and general functioning. Analysis was by modified intent to treat (excluding only 3 who withdrew consent) for hospitalization and completers for other outcomes.
Results
After one year, STEP effected reductions on all measures of inpatient utilization vs. usual treatment: not psychiatrically hospitalized (77% vs. 56%, RR 1.38, 95% confidence interval (CI) 1.08–1.58); mean hospitalizations (0.33±0.70 vs. 0.68±0.92, p=0.02) and mean bed days (5.34±13.53 vs. 11.51±15.04, p=0.05). For every 5 patients allocated in STEP vs. usual treatment, one additional patient avoided psychiatric hospitalization over the first year (NNT = 5, CI 2.7–26.5). STEP also delivered better vocational engagement (91.7% vs. 66.7%, RR 1.40, 95% CI 1.18–1.48) and salutary trends in measures of global functioning.
Conclusions
This trial demonstrates the feasibility and effectiveness of a U.S. public sector model of early intervention for psychotic illnesses. Such services can also support translational research and are a relevant model for other serious mental illnesses.
Trial registration
www.ClinicalTrials.gov: NCT00309452.