UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038161