A multicenter randomized control trial in Japan of comprehensive early intervention in first-episode psychosis

INTERVENTION: Casemanagement (CM) group: Participants will receive standard medical care and additional case management from well‐trained case managers about their symptoms and daily activities for 18 months after registration. Case managers will promote participants' recovery and social participation in cooperation with the early intervention team, using combination of cognitive behavioral therapeutic approach, psychoeducational approach, family intervention, discharge support, and pharmacological therapy in accordance with the guideline for first‐episode psychosis. After 18‐month follow‐up, the participants will receive only standard medical care at each site. Standard care (SC) group: Participants receive only standard medical care at each site. CONDITION: Patients diagnosed as having ICD‐10 (International Classification of Disease, 10th revision) F2 or F3 with psychotic symptoms PRIMARY OUTCOME: Global Assessment of Functioning, Function domain (GAF‐F) scores in the first endpoint (18 months after registration) SECONDARY OUTCOME: GAF‐F, Global Assessment of Functioning, Symptom domain (GAF‐S), Positive And Negative Symptom Scales (PANSS), the World Health Organization Quality Of Life 26‐item version (WHO‐QOL26), care satisfaction, educational and vocational recovery rate, relapse rate, lost to follow‐up rate, self‐harm and suicidal attempt rate, suicide rate, number of visit to out‐patient units, days of stay in hospital, Brief Evaluation of Medication Influences and Beliefs (BEMIB), and direct and indirect costs at each endpoint (18 months, 36 months, and 60 months). INCLUSION CRITERIA: 1. within 5 years from onset of psychotic symptoms. 2. first‐episode psychosis. 3. live in the catchment area of each site. 4. have presented written informed consent to the ethical committee of each site, according to the Declaration of Helsinki after having been given a complete explanation of this study.