[Randomized controlled trial on effectiveness of the community re-entry program to inpatients with schizophrenia spectrum disorder, centering around acquisition of illness self-management knowledge].

Objective: The objective of this study was to examine by randomized controlled trial the effectiveness and safety of the Japanese version of the Community Re-Entry Program, a manualized psycho-educational program with cognitive-behavioral therapy techniques, in discharge preparation for inpatients with schizophrenia. Our hypotheses are that firstly the program is effective for patients in acquiring illness self-management knowledge, that secondly the program shows positive effects on objective behavior and symptoms, and that thirdly the program has no adverse effects on subjective quality of life (QOL).

Method: The subjects were 32 psychiatric inpatients, 24 male and 8 female, hospitalized in psychiatric rehabilitation wards, who gave written informed consent to participate in this study. The Community Re-Entry Program consists of 16 small-group sessions of one hour each that teach illness self-management knowledge and related skills to prepare patients for discharge from hospital and re-entry to the community with cognitive-behavioral techniques such as demonstration, roleplay, feedback, behavioral modeling and homework assignments. A specialized trainer's manual, demonstration videotape and patient workbook are utilized in the program. The program content includes defining discharge readiness, identifying symptoms and medication effects, assisting with discharge planning, connecting with community care, medication self-management, monitoring relapse warning signs, and preparing for emergencies. Except for considerations of the sex ratio in both groups, subjects were randomly allocated to the program (the program group) or ordinary occupational therapy (the control group). Of 32 patients, 31 were diagnosed with schizophrenia and 1 with schizotypal disorder. For the patients in the program group, we administered the program of 16 sessions as well as introductory and closing sessions, twice a week for 9 successive weeks. Nursing staffs in the wards took the roles of trainers with careful fidelity to the manual and supervision by psychiatrists with extensive experience in cognitive-behavioral therapy. The subjects were assessed concerning psychopathology with PANSS by psychiatrists, objective behavior with REHAB by nurses, subjective QOL with subjects' self-reports on WHO/QOL-26 and illness self-management knowledge also by self-report questionnaire attached to the trainers' manual of the program, before and after the whole program.

Results: Before the program, no significant differences were observed between groups concerning age, illness duration, education, length of current hospitalization, amount of antipsychotic medication, psychopathology, objective behavior, subjective QOL and illness self-management knowledge. One patient dropped out of the program because of transient ischemic attack. After the program, the patients in the program group significantly improved in illness self-management knowledge, as well as in speech skills and social activity score, factors of REHAB concerned with objective behavior evaluation, compared with those in the control group. Positive symptoms thus seemed to improve in the patients in the program group compared with those in the control group. No significant changes were observed in other items, including subjective QOL, in the patients of both groups. No patients experienced psychotic relapse in the observation term.

Discussion: We consider that the results supported most of our hypotheses, as they showed positive effects of the program in learning illness self-management knowledge, objective behavior and possible positive effect on positive symptoms, and no adverse effects were observed in psychopathology, behavior or subjective QOL. Further study is necessary on illness self-management behavior acquisition and the effects on long-term clinical outcomes. Study on whether the program is effective for younger patients with shorter hospitalization are expected, because the subjects in this study were rather older (45.9 +/- 11.5 years in the program group) and hospitalized longer (37.8 +/- 36.7 months in the program group).

Conclusion: The Japanese version of the program was effective and relatively safe for schizophrenia spectrum disorder inpatients for learning illness self-management knowledge in preparation for discharge and planning community re-entry.