UMIN-CTR Clinical Trial

Public title

Feasibility study of Online CREW for workers' mental and physical health.

Acronym

Feasibility study of Online CREW for workers' mental and physical health.

Scientific Title

Feasibility study of Online CREW for workers' mental and physical health.

Scientific Title:Acronym

Feasibility study of Online CREW for workers' mental and physical health.

Region

Japan

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the effectiveness of the online CREW program during six months for workplace social capital, as a primary outcome, among workers, with a pretest-posttest study design.
The study also aimed to examine the effectiveness of this program for improving workplace well-being, psychological distress, Civility level, job performance, and job resources as secondary outcomes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Workplace social capital measured by the WSC scale at pre-intervention, mid-point-intervention, post-intervention, and three-month follow-up.

Key secondary outcomes

Workplace well-being (the 24-item the University of Tokyo Occupational Mental Health (TOMH) well-being scale)
Psychological distress (K6)
Civility level (The Japanese version of the CREW Civility scale)
Job performance (WHO Health and Performance Questionnaire)
Job resources (the Brief Job Stress Questionnaire)

All outcomes will be measured before intervention, mid-point-intervention, post-intervention, and three-month after intervention.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

About 15 minutes of CREW program session per session, about 12 times during about 6 months, will be implemented in the workplace. The content of the session is a dialogue in accordance with the theme of the participants. The theme is set for each workplace each time, but be sure to set a theme to think about "respect and respect to each other".
A facilitator proceeding the session is recruited from other than the employee another workplace in the same facility. 3 hours of facilitator training will be held for employees who applied for. The content of training consists of "explanation about CREW program", "basic role and principle of a facilitator" and "session practice exercise".

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Worker with telecommuting

Key exclusion criteria

worker with not telecommuting once a week or more

Target sample size

50

Name of lead principal investigator

1st name	Utako
Middle name
Last name	Sawada

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Psychiatric Nursing

Zip code

113-0033

Address

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

TEL

0358413584

Email

utauta-tky@umin.ac.jp

Name of contact person

1st name	Utako
Middle name
Last name	Sawada

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Psychiatric Nursing

Zip code

113-0033

Address

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

TEL

0358413584

Homepage URL

Email

utauta-tky@umin.ac.jp

Institute

Department of Psychiatric Nursing, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

The Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Medicine, The University of Tokyo

Address

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

Tel

0358413584

Email

utauta.tky@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本に所在する企業（詳細未定）

Date of disclosure of the study information

2021

Year

07

Month

05

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

2021

Year

06

Month

30

Day

Date of IRB

2021

Year

06

Month

30

Day

Anticipated trial start date

2021

Year

07

Month

05

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

07

Month

05

Day

Last modified on

2021

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051124