UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trials of occupational therapy based on the Assessment of Positive Occupation (APO) for people with mental disorder
Acronym	Randomized controlled trials of occupational therapy for people with mental disorder
Scientific Title	Randomized controlled trials of occupational therapy based on the Assessment of Positive Occupation (APO) for people with mental disorder
Scientific Title:Acronym	Randomized controlled trials of occupational therapy for people with mental disorder
Region	Japan

Condition
Condition	Schizophrenia, Depression, Other
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effect of intervention of psychiatric occupational therapy based on occupation which has a high possibility to promote well-being for people with mental disorders.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	Recovery Assessment Scale, Positive and Negative Affect Schedule, SF-8 Data collection: Base line, post-intervention (12-weeks), post-follow-up (4 weeks)
Key secondary outcomes	Assessment of Positive Occupation, Evaluation time: pre-intervention, Data collection: Base line, post-intervention (12-weeks), post-follow-up (4 weeks)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Positive occupation-based Practice (intervention group) Intervention period: 12-week
Interventions/Control_2	psychiatric occupational therapy / day hospital intervention (control group) Intervention period: 12-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	15 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Been diagnosed with a mental illness, those who treatment period is equal to or greater than 1 year. 2) A person from 15 years of age or older than 75 years of age. 3) Research is able to understand, those who can agree to participate. 4) Pathology has relatively stable, who is determined to participate in support programs.
Key exclusion criteria	Those who do not meet the selection criteria
Target sample size	53

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Noguchi
Organization	Kibi International University
Division name	Doctor Course, Graduate School of Health Sciences
Zip code	7160018
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
Division name	Doctor Course, Graduate School of Health Sciences
Zip code	7160018
Address	8, Iga-machi, Takahashi city, Okayama, Japan
TEL	090-1680-3121
Homepage URL
Email	n.takuya19780822@gmail.com

Sponsor
Institute	Kibi International University
Institute
Department

Funding Source
Organization	Kibi International University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawaguchi Clinic Mannari Hospital Kurashikishinkeika Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kibi International University
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	慈圭病院（岡山県），万成病院（岡山県），河口医院（岡山県），倉敷神経科病院（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 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	2016 Year 02 Month 11 Day
Date of IRB	2016 Year 02 Month 11 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2016 Year 11 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 22 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/icdr_e/ctr_view.cgi?recptno=R000024211