UMIN-CTR Clinical Trial

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
Email	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
Email	kmsy-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048566