John M Kane1, Delbert G Robinson1, Nina R Schooler1, Kim T Mueser1, David L Penn1, Robert A Rosenheck1, Jean Addington1, Mary F Brunette1, Christoph U Correll1, Sue E Estroff1, Patricia Marcy1, James Robinson1, Piper S Meyer-Kalos1, Jennifer D Gottlieb1, Shirley M Glynn1, David W Lynde1, Ronny Pipes1, Benji T Kurian1, Alexander L Miller1, Susan T Azrin1, Amy B Goldstein1, Joanne B Severe1, Haiqun Lin1, Kyaw J Sint1, Majnu John1, Robert K Heinssen1. 1. From the Division of Psychiatry Research, Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Glen Oaks, N.Y.; the Departments of Psychiatry and of Molecular Medicine, Hofstra North Shore-Long Island Jewish School of Medicine, and the Department of Mathematics, Hofstra University, Hempstead, N.Y.; the Feinstein Institute for Medical Research, Manhasset, N.Y.; the Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Bronx, N.Y.; the Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, N.Y.; the Departments of Occupational Therapy, Psychiatry, and Psychology, Center for Psychiatric Rehabilitation, Boston University, Boston; the Departments of Psychology and of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, N.C.; the School of Psychology, Australian Catholic University, Melbourne; the Department of Psychiatry, Yale Medical School, and Yale School of Public Health, New Haven, Conn.; the Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, Alta., Canada; the Geisel School of Medicine, Dartmouth College, Lebanon, N.H.; the Bureau of Behavioral Health, New Hampshire Department of Health and Human Services, Concord, N.H.; Nathan Kline Institute, Orangeburg, N.Y.; Minnesota Center for Chemical and Mental Health, School of Social Work, University of Minnesota, St. Paul; the Semel Institute of Neuroscience and Human Behavior, UCLA, Los Angeles; University of Texas Southwestern Medical Center, Dallas; the Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, Tex.; and the Division of Services and Intervention Research, NIMH, Rockville, Md.
Abstract
OBJECTIVE: The primary aim of this study was to compare the impact of NAVIGATE, a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis designed for implementation in the U.S. health care system, with community care on quality of life. METHOD: Thirty-four clinics in 21 states were randomly assigned to NAVIGATE or community care. Diagnosis, duration of untreated psychosis, and clinical outcomes were assessed via live, two-way video by remote, centralized raters masked to study design and treatment. Participants (mean age, 23) with schizophrenia and related disorders and ≤6 months of antipsychotic treatment (N=404) were enrolled and followed for ≥2 years. The primary outcome was the total score of the Heinrichs-Carpenter Quality of Life Scale, a measure that includes sense of purpose, motivation, emotional and social interactions, role functioning, and engagement in regular activities. RESULTS: The 223 recipients of NAVIGATE remained in treatment longer, experienced greater improvement in quality of life and psychopathology, and experienced greater involvement in work and school compared with 181 participants in community care. The median duration of untreated psychosis was 74 weeks. NAVIGATE participants with duration of untreated psychosis of <74 weeks had greater improvement in quality of life and psychopathology compared with those with longer duration of untreated psychosis and those in community care. Rates of hospitalization were relatively low compared with other first-episode psychosis clinical trials and did not differ between groups. CONCLUSIONS: Comprehensive care for first-episode psychosis can be implemented in U.S. community clinics and improves functional and clinical outcomes. Effects are more pronounced for those with shorter duration of untreated psychosis.
RCT Entities:
OBJECTIVE: The primary aim of this study was to compare the impact of NAVIGATE, a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis designed for implementation in the U.S. health care system, with community care on quality of life. METHOD: Thirty-four clinics in 21 states were randomly assigned to NAVIGATE or community care. Diagnosis, duration of untreated psychosis, and clinical outcomes were assessed via live, two-way video by remote, centralized raters masked to study design and treatment. Participants (mean age, 23) with schizophrenia and related disorders and ≤6 months of antipsychotic treatment (N=404) were enrolled and followed for ≥2 years. The primary outcome was the total score of the Heinrichs-Carpenter Quality of Life Scale, a measure that includes sense of purpose, motivation, emotional and social interactions, role functioning, and engagement in regular activities. RESULTS: The 223 recipients of NAVIGATE remained in treatment longer, experienced greater improvement in quality of life and psychopathology, and experienced greater involvement in work and school compared with 181 participants in community care. The median duration of untreated psychosis was 74 weeks. NAVIGATE participants with duration of untreated psychosis of <74 weeks had greater improvement in quality of life and psychopathology compared with those with longer duration of untreated psychosis and those in community care. Rates of hospitalization were relatively low compared with other first-episode psychosis clinical trials and did not differ between groups. CONCLUSIONS: Comprehensive care for first-episode psychosis can be implemented in U.S. community clinics and improves functional and clinical outcomes. Effects are more pronounced for those with shorter duration of untreated psychosis.
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