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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019569
Receipt No. R000022626
Scientific Title Efficacy of individual occupational therapy for patients with schizophrenia: a multicenter randomized controlled trial
Date of disclosure of the study information 2015/11/01
Last modified on 2020/06/09

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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/ctr_e/ctr_view.cgi?recptno=R000022626

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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