UMIN-CTR Clinical Trial

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	75 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 09 Month 19 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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