UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033465 |
|---|---|
| Receipt number | 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 09:15:15 |
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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
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
kouima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038161
