UMIN-CTR Clinical Trial

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
Institute	The University of Tokyo
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056306