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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042532
Receipt No. R000048547
Scientific Title Individualized occupational therapy for schizophrenia
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/24

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Basic information
Public title Individualized occupational therapy for schizophrenia
Acronym Individualized occupational therapy for schizophrenia
Scientific Title Individualized occupational therapy for schizophrenia
Scientific Title:Acronym Individualized occupational therapy for schizophrenia
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of individualized occupational therapy for schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognition
Rehospitalization
Cost-effectiveness
Key secondary outcomes Intrinsic motivation
QOL
Social functioning
Psychiatric symptom
Functioning

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Individualized occupational therapy
Interventions/Control_2 Group occupational therapy
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
60 years-old >
Gender Male and Female
Key inclusion criteria (1) diagnosed with schizophrenia based on the the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Key exclusion criteria (1) a current primary DSM-5 diagnosis other than schizophrenia
(2) a history of mental retardation
(3) a history of neurological disorder
(4) a history of significant drug or alcohol abuse
(5) current risk of suicide, or a history of suicidal behavior within 6 months prior to consent
(6) comorbid serious physical disorder
Target sample size 116

Research contact person
Name of lead principal investigator
1st name Haruki
Middle name
Last name Nakamura
Organization Japanese Association of Occupational Therapists
Division name Japanese Association of Occupational Therapists
Zip code 111-0042
Address 7F Morimitsushinkou Building, 1-5-9 Kotobuki, Taito-ku, Tokyo, Japan
TEL 03-5826-7871
Email rec-jaot@jaot.or.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 Japanese Association of Occupational Therapists
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 Japanese Association of Occupational Therapists
Address 7F Morimitsushinkou Building, 1-5-9 Kotobuki, Taito-ku, Tokyo, Japan
Tel 03-5826-7871
Email rec-jaot@jaot.or.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

Other administrative information
Date of disclosure of the study information
2020 Year 12 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 24 Day
Last modified on
2020 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048547

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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