![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 | 2019/09/19 |
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 |
|
Condition | ||
Condition | Schizophrenia, depression, pervasive developmental disorder, organic psychotic disorder, bipolar disorder, intellectual disorder, social anxiety disorder | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 | 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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |