臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 01, 2021
Last modified on	Nov. 01, 2021
Trial ID	jRCT1020210045

Scientific Title	Effects of Social Cognition and Interaction Training (SCIT) on Employment for Patients with Schizophrenia
Public Title	Effects of Social Cognition and Interaction Training (SCIT) on Employment

Contact for Scientific Queries	Name	Tsunaiguchi Hiroki
	Affiliation	Iwate Prefectural Nanko Hospital
	Address	17 Kozenji Ichinoseki-shi Iwate-ken Japan
	Telephone	+81-191-23-3655
	E-mail	h21gg406@hirosaki-u.ac.jp
Contact for Public Queries	Name	Tsunaiguchi Hiroki
	Affiliation	Iwate Prefectural Nanko Hospital
	Address	17 Kozenji Ichinoseki-shi Iwate-ken Japan
	Telephone	+81-191-23-3655
	E-mail	h21406@hirosaki-u.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Nov. 01, 2021
Actual date of first enrollment
Target sample size		50
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Schizophrenia patient
	Exclusion Criteria	Intellectual disabilities
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Schizophrenia
Intervention(s)		SCIT is conducted in a lecture format based on the Social Cognition and Interaction Training (SCIT) treatment manual, with lectures following the textbook and role-plays on the accompanying DVD. The SCIT group consists of 5 to 8 people, and the target group is non-working people. The instructor should be one or two day care staff. The duration of SCIT is 40 to 60 minutes per session, and the number of sessions is 20 to 24. The sessions will be held in private rooms such as day care rooms and occupational therapy rooms at the hospital.
Health Condition(s) Keyword
Intervention(s) Keyword		Social Cognition
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Demographic data included age, gender, number of hospitalizations, years of education, Body Mass Index (BMI), duration of illness, cumulative length of hospitalization, medication status, participation rate in psychiatric day care (number of times participated/number of times performed x 100: %), information on the form of rehabilitation participation (psychiatric day care), neurocognitive functioning, social cognitive functioning Occupational readiness, occupational aptitude, stress coping skills, stigma, mental resilience, motivation
Secondary Outcome(s)

Primary Sponsor	Hiroki Tsunaiguchi

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Ethics of Hirosaki University Graduate School of Health Sciences,
Address	66-1 Honcho Hirosaki-shi, Aomori
Telephone	+81-172-39-5910
E-Mail	jm5910@hirosaki-u.ac.jp
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none