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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028564
Receipt No. R000032691
Scientific Title Non-randomized controlled trial in short-term intervention of Positive Occupation Based Practice (POBP) for people with mental disorders
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/26

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Basic information
Public title Non-randomized controlled trial in short-term intervention of Positive Occupation Based Practice (POBP) for people with mental disorders
Acronym Non-randomized controlled trial of practice rooted in positive occupation (short term intervention version)
Scientific Title Non-randomized controlled trial in short-term intervention of Positive Occupation Based Practice (POBP) for people with mental disorders
Scientific Title:Acronym Non-randomized controlled trial of practice rooted in positive occupation (short term intervention version)
Region
Japan

Condition
Condition Schizophrenia, depression, pervasive developmental disorder, organic psychotic disorder, bipolar disorder, intellectual disorder, social anxiety disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of short term intervention on POBP for people with mental disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Recovery Assessment Scale
2) Positive and Negative Affect Schedule
3) The Subjective Well-Being Scale
4) Life Assessment Scale for the Mentally
5) WHO disability assessment schedule 2.0
Key secondary outcomes 1) Assessment of Positive Occupation 15
2) Equating Assessment of Positive Occupation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Positive occupational therapy (intervention group)
Interventions/Control_2 Regular occupational therapy, psychiatric day care, intervention being done at the workplace (control group)
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
15 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Persons with mental illness
2) Age from 15 years old to under 85
3) Those who can understand the contents of this research and agree to participate
4) Under the judgment of the attending physician or the responsible person, the medical condition is relatively stable and it is judged that it is possible to participate in POBP
Key exclusion criteria Those who do not meet the selection criteria
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Noguchi
Organization Kibi international University of Japan health welfare laboratory
Division name Associate Professor, Health and Welfare Research Institute
Zip code 716-8508
Address 8, Iga-machi, Takahashi city, Okayama, Japan
TEL 090-1680-3121
Email n.takuya19780822@gmail.com

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Noguchi
Organization Kibi international University of Japan health welfare laboratory
Division name Associate Professor, Health and Welfare Research Institute
Zip code 716-8508
Address 8, Iga-machi, Takahashi city, Okayama, Japan
TEL 090-1680-3121
Homepage URL
Email n.takuya19780822@gmail.com

Sponsor
Institute Kibi international University of Japan health welfare laboratory
Institute
Department

Funding Source
Organization Kibi international University of Japan health welfare laboratory
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kurashikishinkeika Hospital
Ajino Clinic
Heart-switch syurouikoushien
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kibi international University of Japan health welfare laboratory
Address 8, Iga-machi, Takahashi city, Okayama, Japan
Tel 090-1680-3121
Email n.takuya19780822@gmail.com

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
2017 Year 09 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
Delay expected
Results Delay Reason Submitting paper
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
2017 Year 05 Month 01 Day
Date of IRB
2017 Year 05 Month 01 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2018 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
2017 Year 08 Month 07 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032691

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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