UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046729 |
|---|---|
| Receipt number | R000053313 |
| Scientific Title | Effect of Internet-based behavioral activation program on increasing work engagement among workers: before-and-after trial. |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2022/12/20 12:20:58 |
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Basic information
Public title
Effect of Internet-based behavioral activation program on increasing work engagement among workers: before-and-after trial.
Acronym
Effect of Internet-based behavioral activation program on increasing work engagement among workers: before-and-after trial.
Scientific Title
Effect of Internet-based behavioral activation program on increasing work engagement among workers: before-and-after trial.
Scientific Title:Acronym
Effect of Internet-based behavioral activation program on increasing work engagement among workers: before-and-after trial.
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Internet-based behavioral activation program on increasing work engagement among workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work engagement (UWES)
Key secondary outcomes
Psychological distress (K6)
Worker's well-being (TOMH well-being 24 scale)
Work performance (HPQ)
Behavioral activation (BADS-SF)
Sick leave days
Implementation outcomes (iOSDMH)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Internet-based behavioral activation program
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Having psychological distress (K6 score >=5)
Key exclusion criteria
1) self-employed
Target sample size
100
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
0358413521
norito@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
0358413612
Homepage URL
kouima-tky@umin.ac.jp
Sponsor or person
Institute
Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Fujitsu Japan Limited
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
Office for Human Research Studies (OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
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
| 2022 | Year | 01 | Month | 25 | 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
| 2022 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053313
