UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043370
Receipt number R000049521
Scientific Title Effectiveness of organizational intervention in workplace: systematic meta-review
Date of disclosure of the study information 2021/02/20
Last modified on 2021/02/18 16:30:16

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Basic information

Public title

Effectiveness of organizational intervention in workplace

Acronym

Effectiveness of organizational intervention in workplace

Scientific Title

Effectiveness of organizational intervention in workplace: systematic meta-review

Scientific Title:Acronym

Effectiveness of organizational intervention in workplace: systematic meta-review

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To synthesize the results of present systematic reviews and meta-analyses which examined the effectiveness of the organizational intervention at the workplace, by using meta-review methods.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) positive mental health
2) symptom severity, mental health diagnostic status
3) suicide
4) substance use
5) quality of life and functioning
6) work-related outcomes
7) Adverse intervention effects
8) Drop out from intervention

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) using systematic review design
2) including any type of employees/workers as "population"
3) applying any type of organizational intervention at workplace as "intervention"
4) assessing effectiveness using specific outcomes including positive mental health, symptom severity, mental health diagnostic status, suicide, substance use, quality of life and functioning, work-related outcomes, adverse intervention effects, or drop out from intervention
5) published after 2010

Key exclusion criteria

1) individual study
2) meta-review
3) narrative review
4) review reported the summarized results of organizational intervention included observational studies

Target sample size



Research contact person

Name of lead principal investigator

1st name Kotaro
Middle name
Last name Imamura

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5841-3612

Email

kouima-tky@umin.ac.jp


Public contact

Name of contact person

1st name Kotaro
Middle name
Last name Imamura

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Mental Health

Zip code

1130033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5841-3612

Homepage URL


Email

kouima-tky@umin.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

World Health Organization

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp


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

2021 Year 02 Month 20 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

Preinitiation

Date of protocol fixation

2020 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 12 Month 01 Day

Last follow-up date

2021 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The present meta-review examines these three research questions as follows;
a) What universally delivered organizational-level interventions improve positive mental health and reduce symptoms of mental health conditions, suicide, and substance use?
b) What organizational-level interventions delivered to civilian health workers, emergency workers, and humanitarian workers improve positive mental health and reduce symptoms of mental health conditions, suicide, and substance use?
c) What organizational-level interventions delivered to workers with symptoms of emotional distress or meeting criteria for mental health conditions improve positive mental health and reduce symptoms of mental health conditions, suicide, and substance use?


Management information

Registered date

2021 Year 02 Month 18 Day

Last modified on

2021 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049521


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name