title: Comprehensive early intervention for patients with first-episode psychosis in Japan (J-CAP): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Comprehensive approaches for patients with psychotic symptoms play essential roles in the symptomatic and functional outcomes of patients, especially during disease onset. In Japan, the shortage of mental health services, particularly for outpatients, and community-based supports has been a major problem. The purpose of this trial is to investigate the effectiveness and affordability of 18-month comprehensive early intervention services for patients with first-episode psychosis compared with typical treatment.
  
  
  METHODS
  This interventional, parallel, single-blinded (open but blinded raters trial) was effectively designed. The participants are patients with a diagnosis of F2 or F3 (International Classification of Disease, 10 th revision), with psychotic symptoms. The inclusion criteria were an age of 15-35 years, onset of psychotic symptoms within 5 years, first-episode psychosis, and residence in the catchment area of each site. Allocation will be conducted equally between case management and standard care groups. After enrollment, standard care will be provided for both groups, and community-based care to promote recovery for 18 months will be provided for the comprehensive approach group. The primary outcome will be the function domain of the global assessment of functioning scores at 18 months after enrollment. Data assessment will be performed at enrollment and 18, 36, and 60 months after enrollment. The target sample size will be 150, and registration will occur from March 1, 2011, to September 30, 2012.
  
  
  CONCLUSIONS
  This trial will provide promising results about the effectiveness and cost-effectiveness of early intervention services in Japan to improve the quality and quantity of community mental health services.
  
  
  BACKGROUND
  This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000005092).
authors.affiliation: Department of Neuropsychiatry, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, 113-8655, Japan. skoike-tky@umin.ac.jp
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Koike
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nishida
authors.forename: Syudo
authors.initials: S
authors.lastname: Yamasaki
authors.forename: Kayo
authors.initials: K
authors.lastname: Ichihashi
authors.forename: Sanae
authors.initials: S
authors.lastname: Maegawa
authors.forename: Tatsunobu
authors.initials: T
authors.lastname: Natsubori
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Harima
authors.forename: Kiyoto
authors.initials: K
authors.lastname: Kasai
authors.forename: Izumi
authors.initials: I
authors.lastname: Fujita
authors.forename: Masanori
authors.initials: M
authors.lastname: Harada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Okazaki
mesh_terms: D000293:Adolescent; D000328:Adult; D019090:Case Management; D003131:Combined Modality Therapy; D003156:Community Mental Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006801:Humans; D007564:Japan; D010348:Patient Care Team; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult