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Treatment of Acute Psychosis Without Neuroleptics: Two-Year Outcomes From the Soteria Project


Journal of Nervous & Mental Disease: April 2003 - Volume 191 - Issue 4 - pp 219-229

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.

It is notable that 30 years after its initial design and implementation and 17 years since completion of data collection, the Soteria project is still producing information relevant to today’s management of psychosis. Soteria’s original aim was to assess whether a specially designed intensive psychosocial treatment, a relationship-focused therapeutic milieu incorporating minimal use of antipsychotic medications for 6 weeks, could produce equivalent or better outcomes in treating newly diagnosed patients with schizophrenia compared with general hospital psychiatric ward treatment with antipsychotic medications. Soteria also intended to reduce the proportion of patients maintained on antipsychotic medications (thereby reducing exposure to drug-induced toxicities) and to reduce the rate at which early-episode clients became chronic users of mental health services. This study is unique in employing a relatively large sample (N = 179) of clients newly diagnosed with DSM-II schizophrenia (diagnoses were subsequently converted to DSM-IV schizophrenia and schizophreniform disorder) in a quasiexperimental research design comparing multiple outcomes at 2 years.

For many years, antipsychotic medications have been the treatment of choice for patients with early episode psychotic disorders (APA, 1997;Cole et al., 1966;Lehman and Steinwachs, 1998). However, prescription of conventional antipsychotics carries substantial risk of drug toxicities (Popp and Trezza, 1998) and structural brain changes (e.g., Madsen et al., 1998). While atypical antipsychotics exhibit a more benign short-term side-effect profile (Worrel et al., 2000), there has not yet been adequate time observing their effects to rule out emergence of additional long-term toxicities. For example, the recently reported association of atypical antipsychotics with diabetes mellitus (Sernyak et al., 2002) is cause for some concern.

In developing the Soteria approach to treatment, the desire to minimize medication-induced toxicities converged with three additional factors: the recognition of significant rates of recovery without drug treatment in early episode psychosis, the observation that many patients do not benefit from medications (through drug treatment resistance and noncompliance), and a valuing of interpersonal care and treatment of mentally ill patients.

Rates of recovery without medications are significant, particularly for those with early episode psychosis. For example, placebo recovery in the acute phase of the early NIMH multisite trial was approximately 37% (Cole et al., 1964), and the placebo-treated group had fewer rehospitalizations at 1 year postdischarge (Schooler et al., 1967). Estimates of placebo response rates for patients with acute schizophrenia range from 10% to 40% (Davis et al., 1989;Thornley et al., 2001), with a median of 25% (Dixon et al., 1995). Long-term follow-up studies conducted prior to the widespread use of antipsychotic drugs report functional recovery rates greater than 50% (Bleuler, 1978;Ciompi, 1980;Huber et al., 1980).

Not all psychotic patients benefit from drug treatment. Treatment resistance to conventional antipsychotic agents is estimated to be 20% to 40% (Hellewell, 1999). Noncompliance with conventional antipsychotics is estimated to be 41% to 55% (Fenton et al., 1997). Improved compliance with atypical antipsychotics is often assumed but has not yet been established (Wahlbeck et al., 2001).

“Traitement moral,” a humanistic trend in the care and treatment of persons with mental illness, can be traced to Pinel’s removing chains from the men in Paris’ Bicetre Hospital in 1797. Following in the humanistic treatment tradition, Soteria incorporated aspects of moral treatment (Bockhoven, 1963), Sullivan’s (1962) interpersonal theory and specially designed milieu at Shepard-Pratt Hospital in the 1920s, and the “developmental crisis” notion that growth may be possible from psychosis (Laing, 1967;Menninger, 1959;Perry, 1974).

This is the first report from the entire Soteria sample using multivariate methods to test hypotheses of comparable outcomes over a 2-year period. We use two-tailed tests to evaluate hypotheses for each outcome in three ways: for endpoint subjects (N = 160), for completing subjects (N = 129), and for completing subjects adjusted for differential attrition (N = 129;Heckman, 1979). Subsequently, we conducted tests for schizophrenia and schizophreniform subjects separately.

1Department of Social Work, University of Southern California, MRF-222, Los Angeles, California 90089-0411. Send reprint requests to Dr. Bola.

2Soteria Associates, San Diego, California.

This research was supported by grants from the National Institute of Mental Health.

Presented in part at the World Psychiatric Association’s International Congress in Madrid, Spain, October 2, 2001.

The authors thank Leonard S. Miller, Ph.D., UC Berkeley, and Jim Mintz, Ph.D., UCLA, for their help with statistical consultations, and John M. Davis, M.D., University of Illinois, for critique of an earlier version of this manuscript.

© 2003 Lippincott Williams & Wilkins, Inc.