Koike‐Japan.

Trial name or title	Comprehensive early intervention for patients with first‐episode psychosis in Japan (J‐CAP): study protocol for a randomised controlled trial.
Methods	Allocation: randomised. Blinding: Only assessors blinded.
Participants	People who received a diagnosis of F2 or F3 (ICD‐10), with psychotic symptoms.
Interventions	1. Comprehensive community‐based care. 2. Standard care. N = expected 150. Age: 15 to 35 years.
Outcomes	Primary outcome: Global Assessment of Functioning (GAF‐F) scores at the first endpoint. Secondary outcomes: GAF‐F at the second and last endpoints, symptom domain of Global Assessment of Functioning (GAF‐S), PANSS, the World Health Organization Quality of Life 26‐item version (WHOQOL‐BREF), Brief Evaluation of Medication Influences and Beliefs (BEMIB), care satisfaction of participants and their families, educational and vocational recovery rates, remission rate, readmission rate, lost to follow‐up rate, self harm and suicide attempt rate, suicide rate, engagement behaviour, and direct and indirect costs at each endpoint.
Starting date	March 2011.
Contact information	skoike‐tky@umin.ac.jp; nishida‐at@igakuken.or.jp
Notes	The University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000005092). Expected completion date: September 2017.