UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028564 |
|---|---|
| Receipt number | 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 | 2019/09/19 13:44:41 |
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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
| 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
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
n.takuya19780822@gmail.com
Sponsor or person
Institute
Kibi international University of Japan health welfare laboratory
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032691
