UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021144 |
|---|---|
| Receipt number | R000024211 |
| Scientific Title | Randomized controlled trials of occupational therapy based on the Assessment of Positive Occupation (APO) for people with mental disorder |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/08/26 09:32:00 |
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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
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
n.takuya19780822@gmail.com
Sponsor or person
Institute
Kibi International University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024211
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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