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

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 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

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

Value
https://center6.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