UMIN-CTR Clinical Trial

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
Institute	Graduate School of Medicine, The University of Tokyo
Institute
Department

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
URL(English)	https://upload.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

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