UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a new developed gratitude intervention program on work engagement among Japanese workers: A pretest-posttest study
Acronym	Effects of a new developed gratitude intervention program on work engagement among Japanese workers: A pretest-posttest study
Scientific Title	Effects of a new developed gratitude intervention program on work engagement among Japanese workers: A pretest-posttest study
Scientific Title:Acronym	Effects of a new developed gratitude intervention program on work engagement among Japanese workers: A pretest-posttest study
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to examine the effectiveness of a new developed gratitude intervention program on work engagement, as primary outcome, among workers, with a pretest-posttest study design. The study also aims to examine the effectiveness of this program on improving gratitude feeling, work related happiness, self-efficacy, job and life satisfaction, social capital, supervisor / coworker support, job performance, and non-specific psychological distress as secondary outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Work Engagement measured by Utrecht Work Engagement Scale (UWES-9) at pre-intervention, post-intervention (3-week after), and 9-week follow-up.
Key secondary outcomes	Gratitude feeling measured by gratitude questionnaire. Work related happiness measured by Workplace PERMA-Profiler. Self-efficacy measured by generalized efficacy scale. Job and life satisfaction, social capital, supervisor / coworkers support measured by the Brief Job Stress Questionnaire Work performance measured by WHO Health and Performance Questionnaire (HPQ) Non-specific psychological distress measured by K6.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	A program composed of workshop and sending work related gratitude e-mails three days a week (on Monday, Wednesday and Friday) for three weeks. Participants will be given a gratitude dairy which shows the accumulated gratitude after gratitude e-mails everytime. There are four aims of workshop. First, to tell the merit of feeling gratitude. Second, to be easy to feel gratitude. Third, to promote the expression of gratitude to others. Fourth, to increase autonomy toward the program. The aim of sending gratitude e-mails and giving accumulated gratitude dairy are to increase gratitude feeling.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	employees
Key exclusion criteria	None
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norito Kawakami
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Mental health
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3522
Email	norito@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yu Komase
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Psychiatric Nursing
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3522
Homepage URL
Email	kmsy-tky@umin.ac.jp

Sponsor
Institute	Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 02 Month 23 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	Main results already published
Date of protocol fixation	2018 Year 02 Month 23 Day
Date of IRB	2017 Year 11 Month 29 Day
Anticipated trial start date	2018 Year 02 Month 27 Day
Last follow-up date	2018 Year 10 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 20 Day
Last modified on	2019 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035847