Abstract
IntroductionComprehensive 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.MethodsThis 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.DiscussionThis 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.Trial registrationThis trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000005092).
Highlights
Comprehensive approaches for patients with psychotic symptoms play essential roles in the symptomatic and functional outcomes of patients, especially during disease onset
To change this situation and broaden early intervention services (EIS) based on community settings, an randomized controlled trials (RCTs) is needed to confirm the clinical effectiveness and affordability of EIS compared with existing hospital-based mental health service systems in Japan
Previous studies of EIS for patients with first-episode psychosis (FEP) have suggested that 1.5-year EIS improved patient social functions and readmission rates, these effects did not persist (5 years)[23,24]. These results depend on the treatment provided to the control group, and community mental health services are widely available in Holland and England[1]
Summary
Trial design This trial is designed with effectiveness, interventional, parallel, single-blinded (open but blinded raters) trial. Several studies have suggested that psychoeducation is effective for relapse prevention, reducing hospital admission, and adherence of medication[16,17,18] In this trial, the psychoeducational program for people with FEP will consist of sessions that provide information about etiology, symptoms, treatments, and outcome of psychosis, and positive and helpful information toward functional recovery. Secondary outcomes will be GAF-F at the second and last end points, symptom domain of global assessment of functioning (GAF-S), PANSS,[12] the World Health Organization quality of life 26-item version (WHO-QOL26),[26,27] brief evaluation of medication influences and beliefs (BEMIB),[28] care satisfaction of participants and their families, educational and vocational recovery rates, remission rate, re-admission rate, lost to follow-up rate, self-harm and suicide attempt rate, suicide rate, engagement behavior, and direct and indirect costs at each end point. Subgroup analysis will be conducted at sites and performed for any possible confounders to differentiate the effectiveness of each situation and explore cluster effects
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