UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042546 |
|---|---|
| Receipt number | R000048566 |
| Scientific Title | Effects of a gratitude intervention program on work engagement among Japanese workers: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2022/05/29 16:35:53 |
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Basic information
Public title
Effects of a gratitude intervention program on work engagement among Japanese workers: a cluster randomized controlled trial
Acronym
Effects of a gratitude intervention program among workers
Scientific Title
Effects of a gratitude intervention program on work engagement among Japanese workers: a cluster randomized controlled trial
Scientific Title:Acronym
Effects of a gratitude intervention program among workers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to test the following two hypotheses.
1) The gratitude intervention would improve work engagement, as the primary outcome, in workers assigned to the intervention group, compared with those in the control group.
2)The gratitude intervention would improve the level of gratitude at work, personal resources (self-efficacy and sense of coherence), job resources (support from supervisors and coworkers), well-being (eudaimonic well-being at work and psychological distress), and work performance ( as secondary outcomes) in workers assigned to the intervention group, compared with those in the control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work engagement will be measured by the Utrecht Work Engagement Scale.
(It will be measured before randomization as baseline, 1, 3 and 6 months follow-up after baseline)
Key secondary outcomes
1) Gratitude at work measured by the gratitude at work scale
2) Self-efficacy measured by the self-efficacy scale
3) Sense of coherence measured by the sense of coherence scale.
4) Supervisor and coworker support measured by the Brief Job Stress Questionnaire (BJSQ)
5) Eudaimonic well-being at work measured by the 24-item University of Tokyo Occupational Mental Health well-being scale (TOMH well-being 24)
6) Psychological distress will be measured by the K6
7) Work performance will be assessed by the WHO Health and Work Performance Questionnaire (WHO- HPQ).
All outcomes will be measured before randomization as baseline, 1, 3 and 6 months follow-up after baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The gratitude intervention is a four-week program implemented on an organization basis. It consists of three elements: psychoeducation, gratitude lists: making written lists of several things for which one is grateful regularly, and behavioral gratitude expression: expressing gratitude to others. Psychoeducation is delivered for a week in week 1. Then, gratitude lists and behavioral gratitude expressions are conducted three weeks in week 2 to week 4. Gratitude lists are programs that correspond to increasing personal resources, and behavioral gratitude expressions are programs that correspond to increasing job resources. Psychological education aims to provide an overview of the program and help participants implementation of these activities.
In this study, we regard a group of departments, sections, or teams working together in a company as an organization.
Interventions/Control_2
Participants belonging to the organizations allocated to the control group do not receive any intervention programs until they complete the 6-month follow-up survey. After that, those enrolled in the control group will receive the same intervention program as the intervention group.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are more than twenty years old
2) Those who belong to the organizations (temporary workers employed by other companies and work at the same organization will be included in the study.)
3) Those who work at the same organization three days a week or more
4) Those who with Internet access from smartphones, tablets or computers
Key exclusion criteria
None
Target sample size
1274
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Komase |
Organization
The University of Tokyo
Division name
Department of Mental Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
TEL
08012526415
kmsy-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Komase |
Organization
The University of Tokyo
Division name
Department of Mental Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
TEL
08012526415
Homepage URL
kmsy-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for JSPS Fellows
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Faculty of Medicine Bldg. 2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
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
| 2020 | Year | 11 | Month | 25 | 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
1187
Results
There was no effect on the primary outcome of work engagement, but there was a significant result on the secondary outcome of psychological distress.
Results date posted
| 2021 | Year | 11 | Month | 26 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048566
