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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033465
Receipt No. R000038161
Scientific Title Effects of psychoeducational intervention programs applying gamification on improving psychological distress and work engagement among workers: Four-arm randomized controlled trial
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/22

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Basic information
Public title Effects of psychoeducational intervention programs applying gamification on improving psychological distress and work engagement among workers: Four-arm randomized controlled trial
Acronym Effects of psychoeducational intervention programs applying gamification on improving psychological distress and work engagement among workers: Four-arm randomized controlled trial
Scientific Title Effects of psychoeducational intervention programs applying gamification on improving psychological distress and work engagement among workers: Four-arm randomized controlled trial
Scientific Title:Acronym Effects of psychoeducational intervention programs applying gamification on improving psychological distress and work engagement among workers: Four-arm randomized controlled trial
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect of newly developed two psychoeducational program applying gamification (i.e., cognitive behavioral therapy card game and job crafting card game) on improving psychological distress and work engagement among workers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Psychological distress (K6)
2) Work engagement (UWES)
Key secondary outcomes 1) Job crafting (Job crafting scale)
2) On the job performance (HPQ)
3) Knowledge
4) Self-efficacy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Psychoeducational intervention program applying cognitive behavioral therapy card game
Interventions/Control_2 Psychoeducational intervention program applying job crafting card game
Interventions/Control_3 Learning program about the Stress Check Program in Japan applying educational board game
Interventions/Control_4 Waitlist control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Regular employee
Key exclusion criteria 1) Sick leave for 15 or more days for a physical or mental condition in the past 3 months.
2) Current treatment for a mental health problem from a mental health professional.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Norito
Middle name
Last name Kawakami
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Mental Health
Zip code 1130033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3364
Email nkawakami@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Kotaro
Middle name
Last name Imamura
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Mental Health
Zip code 1130033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3612
Homepage URL
Email kouima-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
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
2018 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 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 07 Month 21 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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