UMIN-ICDS Clinical Trial

Public title

Organizational interventions aiming to prevent depression and anxiety among workers: Multifaced ORganizarional InterventiONs, M-ORION Project

Acronym

Multifaced ORganizarional InterventiONs, M-ORION Project

Scientific Title

A five-arm cluster randomized controlled trial aiming to prevent depression and anxiety among workers: Multifaced ORganizarional InterventiONs (M-ORION Project)

Scientific Title:Acronym

Multifaced ORganizarional InterventiONs, M-ORION Project

Region

Japan

Condition

Depression and anxiety

Classification by specialty

Neurology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The present study aims to assess the preventive effects of four types of organizational interventions on the prevention of depression and anxiety among workers. Non-specific psychological distress will be used as an indicator of depression and anxiety. The interventions include psychoeducation for workers and supervisors, work environment improvement, and promotion of physical activity. The intervention programs contain Internet-delivered or smartphone-delivered content using information communication technologies. As secondary outcomes, the effects on psychosocial factors at work, work engagement, health-related QOL, well-being, economic outcomes, physiological outcomes of a health checkup, and cortisol levels extracted from fingernails will also be characterized. Further, the process and implementation outcomes of the intervention programs will be evaluated for their future dissemination in the workplace.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Psychological distress (an indicator of depression and anxiety, measured by the Japanese version of K6)

Key secondary outcomes

Work engagement (UWES-9)
Quality of Life (EQ-5D-5L)
Well-being (Workplace PERMA Profiler)
Work Performance (WHO-HPQ)
Psychological safety (Psychological Safety Scale)
Stress response (BJSQ)
Satisfaction (BJSQ)
Absenteeism (personal record)
Turnover (personal record)
Salary (monthly, personal record)
Bonus (yearly, personal record)
(Job stressors [BJSQ])
(Workplace social support [BJSQ])
Items in the health checkup: height, weight, waist circumference, blood pressure, serum lipids, blood sugar
Biomarkers (cortisol from nails)
Process evaluation: program completion rate (recorded data)
Usefulness evaluation: acceptability, appropriateness, feasibility, satisfaction of the program

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

5

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Other

Interventions/Control_1

Psychoeducation for workers
Workers in the worksites allocated to this intervention group will be asked to use a smartphone or tablet application that provides psychoeducation on job crafting for 6 months. The contents of the application include 1) learning job crafting concepts, 2) creating a job crafting plan, and 3) reflecting on the job crafting plan.

Interventions/Control_2

Psychoeducation for supervisors
Supervisors at the worksites allocated to this arm will be asked to learn a supervisor-training program based on the rationale of psychological safety for 6 months. This program will be provided via video content and text messages to facilitate measures to enhance psychological safety in the workplace.

Interventions/Control_3

Work environment improvement
Workers engaged in the worksites in this intervention group will participate in the Participatory Work Environment Improvement Program (PWIP) for 7-12 months to improve the psychosocial factors of the workplace. The PWIP will be implemented according to the results of the PWIP feasibility assessment. Workers will use smartphones or the web to identify the favorable conditions and conditions that need improvement in the workplace, participate in group work, and actually contribute to the improvement. The PWIP consists of three sessions: 1) kick-off work (first time), 2) follow-up (1-3 months later), and 3) result announcement/report (6-12 months later). From the start of the PWIP to the follow-up period, facilitators of PWIP outside the workplace will contact the person in charge at the workplace to provide suggestions for the PWIP and assess the progress. The facilitators will conduct a briefing session immediately after the allocation, provide suggestions at the beginning and in the middle, and summarize the results of the program.

Interventions/Control_4

Physical activity promotion
Workers engaged in the worksites in this intervention group will be asked to install and use a smartphone application to improve their physical activity for 6 months. The application will be available after 3 months. The contents of the application include 1) the prediction of users' levels of depression and anxiety the next day; 2) feedback and suggestions to improve physical activity based on the results of the prediction; and 3) the categorization of users by occupational conditions, preference, and physical activity patterns.

Interventions/Control_5

Active control
Workers engaged in worksites in this group will be asked to download and read a booklet that provides basic information about stress for 6 months. No assistance other than the booklet will be provided.

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria for the worksites:
1) conducting the National Stress Check Program
2) analyzing the results of the National Stress Check Program in sufficiently large groups for work environment improvement
3) employing 5-299 workers subject to the National Stress Check Program
4) with at least one supervisor working with at least one subordinate.

Inclusion criteria for the workers:
1) aged >=18 years
2) can answer the questionnaires written in Japanese
3) have access to the Internet and the intervention programs offered online
4) have a smartphone available in private
5) work at a workplace (or workplaces) where at least one supervisor and one subordinate work together.

Key exclusion criteria

Exclusion criteria for the workers:
1) are absent from the workplace because of health problems in the 12 months before the baseline

Target sample size

18220

Name of lead principal investigator

1st name	Akizumi
Middle name
Last name	Tsutsumi

Organization

Kitasato University School of Medicine

Division name

Department of Public Health

Zip code

252-0374

Address

1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan

TEL

+81-42-778-9352

Email

akizumi@kitasato-u.ac.jp

Name of contact person

1st name	Kazuhiro
Middle name
Last name	Watanabe

Organization

Kitasato University School of Medicine

Division name

Department of Public Health

Zip code

252-0374

Address

1-15-1 Kitazato, Minami-ku, Sagamihara 252-0374, Japan

TEL

+81-42-778-9352

Homepage URL

https://sites.google.com/altpaper.net/m-orion

Email

kzwatan@kitasato-u.ac.jp

Institute

Kitasato University

Institute

Department

Personal name

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

Co-sponsor

1) Graduate School of Medicine, The University of Tokyo
2) National Institute of Occupational Safety and Health, Japan
3) University of Occupational and Environmental Health, Japan
4) IID Co. Ltd.

Name of secondary funder(s)

Organization

Kitasato University Medical Ethics Organization (KMEO)

Address

1-15-1 Kitazato, Minami-ku, Sagamihara 252-0373, Japan

Tel

+81-42-778-8273

Email

rinri@med.kitasato-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

04

Month

01

Day

Date of IRB

2022

Year

09

Month

26

Day

Anticipated trial start date

2023

Year

09

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

2026

Year

10

Month

01

Day

Date trial data considered complete

2031

Year

03

Month

31

Day

Date analysis concluded

2031

Year

03

Month

31

Day

Other related information

Registered date

2023

Year

04

Month

28

Day

Last modified on

2023

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058066