Treatment of acute psychosis without neuroleptics: two-year outcomes from the Soteria project.

The Soteria project (1971-1983) compared residential treatment in the community and minimal use of antipsychotic medication with "usual" hospital treatment for patients with early episode schizophrenia spectrum psychosis. Newly diagnosed DSM-II schizophrenia subjects were assigned consecutively (1971 to 1976, N = 79) or randomly (1976 to 1979, N = 100) to the hospital or Soteria and followed for 2 years. Admission diagnoses were subsequently converted to DSM-IV schizophrenia and schizophreniform disorder. Multivariate analyses evaluated hypotheses of equal or better outcomes in Soteria on eight individual outcome measures and a composite outcome scale in three ways: for endpoint subjects (N = 160), for completing subjects (N = 129), and for completing subjects corrected for differential attrition (N = 129). Endpoint subjects exhibited small to medium effect size trends favoring experimental treatment. Completing subjects had significantly better composite outcomes of a medium effect size at Soteria (+.47 SD, p =.03). Completing subjects with schizophrenia exhibited a large effect size benefit with Soteria treatment (+.81 SD, p =.02), particularly in domains of psychopathology, work, and social functioning. Soteria treatment resulted in better 2-year outcomes for patients with newly diagnosed schizophrenia spectrum psychoses, particularly for completing subjects and for those with schizophrenia. In addition, only 58% of Soteria subjects received antipsychotic medications during the follow-up period, and only 19% were continuously maintained on antipsychotic medications.

RCT Entities:   Population Interventions Outcomes