title: The RAISE early treatment program for first-episode psychosis: background, rationale, and study design.
abstract: OBJECTIVE
  The premise of the National Institute of Mental Health Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team in order to significantly improve the functional outcome and quality of life for first-episode psychosis patients. The study is being conducted in non-academic (ie, real-world) treatment settings, using primarily extant reimbursement mechanisms.
  
  
  METHODS
  We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to "usual care" on quality of life. Secondary aims include comparisons on remission, recovery, and cost-effectiveness. Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible. Patients are followed for a minimum of 2 years, with major assessments conducted by blinded, centralized raters using live, 2-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects. The results of the trial will be published separately. The goal of the article is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness.
  
  
  CONCLUSIONS
  We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01321177.
authors.affiliation: Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd St, Kaufmann Bldg, Ste 103, Glen Oaks, NY 11004 psychiatry@lij.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
authors.forename: Nina R
authors.initials: NR
authors.lastname: Schooler
authors.forename: Patricia
authors.initials: P
authors.lastname: Marcy
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.forename: Mary F
authors.initials: MF
authors.lastname: Brunette
authors.forename: Kim T
authors.initials: KT
authors.lastname: Mueser
authors.forename: Robert A
authors.initials: RA
authors.lastname: Rosenheck
authors.forename: Jean
authors.initials: J
authors.lastname: Addington
authors.forename: Sue E
authors.initials: SE
authors.lastname: Estroff
authors.forename: James
authors.initials: J
authors.lastname: Robinson
authors.forename: David L
authors.initials: DL
authors.lastname: Penn
authors.forename: Delbert G
authors.initials: DG
authors.lastname: Robinson
mesh_terms: D000293:Adolescent; D000328:Adult; D003131:Combined Modality Therapy / Q000592:standards; D061345:Early Medical Intervention / Q000592:standards*; D006801:Humans; D017063:Outcome Assessment, Health Care; D011618:Psychotic Disorders / Q000188:drug therapy / Q000628:therapy*; D012107:Research Design / Q000592:standards*; D012559:Schizophrenia / Q000188:drug therapy / Q000628:therapy*; D055815:Young Adult
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