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

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 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

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

Value
https://center6.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