Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

doi:10.1176/appi.ajp.2015.15050632

Randomized Controlled Trial

. 2016 Apr 1;173(4):362-72.

doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.

Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

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

Affiliations

Affiliation

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.

PMID: 26481174
PMCID: PMC4981493
DOI: 10.1176/appi.ajp.2015.15050632

Randomized Controlled Trial

Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

John M Kane et al. Am J Psychiatry. 2016.

. 2016 Apr 1;173(4):362-72.

doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.

Authors

Affiliation

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.

PMID: 26481174
PMCID: PMC4981493
DOI: 10.1176/appi.ajp.2015.15050632

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.

Trial registration: ClinicalTrials.gov NCT01321177.

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Figures

**Figure 1**
Patient self-report of use of NAVIGATE model targeted services during study period at NAVIGATE and Community Care Sites

**Figure 2**
Model-Based Estimates of Heinrichs-Carpenter Quality of Life (QLS) Total Score and PANSS Total Score.

**Figure 3**
Heinrichs-Carpenter Quality of Life (QLS) Total Score and PANSS Total Score: Effects of Shorter vs. Longer Duration of Untreated Psychosis (DUP) based on a model with square root transformation of months¹.

See this image and copyright information in PMC

Comment in

RAISE-ing Our Expectations for First-Episode Psychosis.
Insel TR. Insel TR. Am J Psychiatry. 2016 Apr 1;173(4):311-2. doi: 10.1176/appi.ajp.2015.15091204. Epub 2015 Oct 20. Am J Psychiatry. 2016. PMID: 26481175 No abstract available.
Response to Amos: Addressing Purported Methodological Flaws in RAISE-ETP Results.
Kane JM, Robinson DG, Schooler NR, Lin H, Rosenheck RA, Heinssen RK; RAISE-ETP Study Group. Kane JM, et al. Am J Psychiatry. 2016 May 1;173(5):535-6. doi: 10.1176/appi.ajp.2016.15111427r. Am J Psychiatry. 2016. PMID: 27133408 No abstract available.
Selection Bias Effects on RAISE-ETP Results.
Amos AJ. Amos AJ. Am J Psychiatry. 2016 May 1;173(5):535. doi: 10.1176/appi.ajp.2016.15111427. Am J Psychiatry. 2016. PMID: 27133409 No abstract available.

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References

1. Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global Burden of Disease and Risk Factors. World Bank; Washington, DC: 2006. - PubMed
1. Jaaskelainen E, Juola R, Hirvonen N, McGrath JJ, Saha S, Isohanni M, Veijola J, Miettunen J. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull. 2013;39(6):1296–306. - PMC - PubMed
1. Bird V, Premkumar P, Kendall T, Whittington C, Mitchell J, Kuipers E. Early intervention services, cognitive-behavior therapy and family intervention in early psychosis: systematic review. British Journal of Psychiatry. 2010;197(5):350–356. - PMC - PubMed
1. Alvarez-Jimenez M, Parker AG, Hetrick SE, McGorry PD, Gleeson JF. Preventing the second episode: A systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophrenia Bulletin. 2011;37(3):619–630. - PMC - PubMed
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[1] Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global Burden of Disease and Risk Factors. World Bank; Washington, DC: 2006. - PubMed

[2] Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global Burden of Disease and Risk Factors. World Bank; Washington, DC: 2006. - PubMed

[3] Jaaskelainen E, Juola R, Hirvonen N, McGrath JJ, Saha S, Isohanni M, Veijola J, Miettunen J. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull. 2013;39(6):1296–306. - PMC - PubMed

[4] Jaaskelainen E, Juola R, Hirvonen N, McGrath JJ, Saha S, Isohanni M, Veijola J, Miettunen J. A systematic review and meta-analysis of recovery in schizophrenia. Schizophr Bull. 2013;39(6):1296–306. - PMC - PubMed

[5] Bird V, Premkumar P, Kendall T, Whittington C, Mitchell J, Kuipers E. Early intervention services, cognitive-behavior therapy and family intervention in early psychosis: systematic review. British Journal of Psychiatry. 2010;197(5):350–356. - PMC - PubMed

[6] Bird V, Premkumar P, Kendall T, Whittington C, Mitchell J, Kuipers E. Early intervention services, cognitive-behavior therapy and family intervention in early psychosis: systematic review. British Journal of Psychiatry. 2010;197(5):350–356. - PMC - PubMed

[7] Alvarez-Jimenez M, Parker AG, Hetrick SE, McGorry PD, Gleeson JF. Preventing the second episode: A systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophrenia Bulletin. 2011;37(3):619–630. - PMC - PubMed

[8] Alvarez-Jimenez M, Parker AG, Hetrick SE, McGorry PD, Gleeson JF. Preventing the second episode: A systematic review and meta-analysis of psychosocial and pharmacological trials in first-episode psychosis. Schizophrenia Bulletin. 2011;37(3):619–630. - PMC - PubMed

[9] Addington J. The promise of early intervention. Early Intervention in Psychiatry. 2007;1(4):294–307. - PubMed

[10] Addington J. The promise of early intervention. Early Intervention in Psychiatry. 2007;1(4):294–307. - PubMed

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Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

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Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program

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