UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial
Acronym	Efficacy of individual occupational therapy for patients with schizophrenia
Scientific Title	Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial
Scientific Title:Acronym	Efficacy of individual occupational therapy for patients with schizophrenia
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	(1) Examine the efficacy of individual occupational therapy on cognitive impairment in schizophrenia (2) Explore of factors related to rehospitalization of patients with schizophrenia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) Brief Assessment of Cognition in Schizophrenia-Japanese version (BACS-J)
Key secondary outcomes	(1) Schizophrenia cognition rating scale Japanese version (SCoRS-J) (2) Social functioning scale Japanese version (SFS-J) (3) Global assessment of functioning (GAF) scale (4) Positive and negative syndrome scale (PANSS) (5) Japanese version of client satisfaction questionnaire (CSQ-8J) (6) Rehospitalization rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	The personalized occupational therapy compose of a combination of (1) individual interview, (2) self-monitoring program, (3) supports for going out and visit guidance, (4) personalized occupational guidance, (5) personalized psycho-education, and (6) guidance at the time of discharge. Occupational therapists implement to set the time one-to-one of these programs. 1-2 hours at a time and 3-5 times at a week.
Interventions/Control_2	The group occupational therapy is activity-oriented group treatment as usual. 1-2 hours at a time and 3-5 times at a week.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) 20-65 years of age (2) newly inpatients hospitalized in mental hospital or beds (3) diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV-TR criteria
Key exclusion criteria	(1) patients with mental retardation (2) patients with any current or past histories of neurological disorders (3) patients with alcohol or drug disorders (abuse or dependence) (4) patients with need of individual intervention for physical dysfunction
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masayoshi Middle name Last name Kobayashi
Organization	Shinshu University
Division name	School of Health Sciences, Faculty of Medicine
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2403
Email	mkobaya@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Shimada
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	386-0401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268-35-0305
Homepage URL
Email	ot@seitaikai.or.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Japanese Association of Occupational Therapists
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinshu University
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	信州大学大学院医学系研究科（長野県）、医療法人清泰会メンタルサポートそよかぜ病院（長野県）、長野県立こころの医療センター駒ヶ根（長野県）、医療法人愛生会松岡病院（長野県）、医療法人蜻蛉会南信病院（長野県）、長野県厚生農業協同組合連合会 北アルプス医療センター あづみ病院（長野県）、社会医療法人栗山会飯田病院（長野県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 06 Day
Date of IRB	2015 Year 10 Month 06 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 30 Day
Last modified on	2020 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022626