UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000049453
Receipt number R000056306
Scientific Title Effects of participatory organizational interventions on mental health and work performance among workers: A systematic review and meta-analysis
Date of disclosure of the study information 2022/11/08
Last modified on 2022/11/08 09:22:27

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Basic information

Public title

Effects of participatory organizational interventions on mental health and work performance among workers: A systematic review and meta-analysis

Acronym

A systematic review and meta-analysis of participatory organizational interventions among workers.

Scientific Title

Effects of participatory organizational interventions on mental health and work performance among workers: A systematic review and meta-analysis

Scientific Title:Acronym

A systematic review and meta-analysis of participatory organizational interventions among workers.

Region

Japan


Condition

Condition

Healthy worker

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to conduct a systematic review and meta-analysis of cluster randomized controlled trials of participatory organizational interventions to improve mental health and work performance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Mental health outcomes
-Work Performance

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

(P) inclusion of all workers
(I) participatory organizational intervention
(C) treatment as usual or no intervention (including waitlist control)
(O) mental health, including positive mental health outcome, negative mental health outcome or performance
(Design) cluster-RCT
-Original articles
-Written in English or Japanese

Key exclusion criteria

N/A

Target sample size



Research contact person

Name of lead principal investigator

1st name Norito
Middle name
Last name Kawakami

Organization

The University of Tokyo

Division name

Graduate School of Medicine, Department of Digital Mental Health

Zip code

03-5800-9621

Address

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

TEL

03-5800-9621

Email

norito@m.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Mako
Middle name
Last name Iida

Organization

The University of Tokyo

Division name

Graduate School of Medicine, Department of Psychiatric Nursing

Zip code

1130033

Address

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

TEL

03-5841-3364

Homepage URL


Email

idamako@m.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development: AMED

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A


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

2022 Year 11 Month 08 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

2022 Year 11 Month 07 Day

Date of IRB


Anticipated trial start date

2022 Year 11 Month 08 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study conducts a systematic review and meta-analysis of cluster randomized controlled trials of participatory organizational interventions to improve mental health and work performance.


Management information

Registered date

2022 Year 11 Month 08 Day

Last modified on

2022 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name