UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051631 |
|---|---|
| Receipt number | R000058861 |
| Scientific Title | Effects of digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2023/07/18 10:13:48 |
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Basic information
Public title
Effects of digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Acronym
Effects of digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title
Effects of digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Scientific Title:Acronym
Effects of digital health interventions for primary prevention on mental health outcomes among workers: systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Mental health
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of non-pharmacological intervention aiming at primary prevention using digital health technologies for mental health conditions, positive mental health, and other work-related outcomes among workers, based on a synthesis of randomized controlled trial studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Mental health conditions (eg., depression, anxiety, psychological distress)
2) Positive mental health (eg., work engagement, mental well-being)
3) Work-related outcomes (eg., sick leave days, work performance)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Studies including any type of employees/workers as "population"
2) Studies applying any type of non-pharmacological interventions aiming at primary prevention using digital health technologies (eg., exercises, diet, lifestyle, psychological intervention such as cognitive behavioral therapy) as "intervention"
3) Studies applying any type of control conditions as "comparison"
4) Studies assessing effectiveness using specific outcomes including mental health conditions, positive mental health, and work-related outcomes as "outcomes"
5) Studies using randomized controlled trial design
6) Studies published after 2010
Key exclusion criteria
1) Studies targeting participants who have any specific disorder.
2) Studies including participants who are not employees/ workers.
3) Studies applying any type of interventions aiming at secondary or tertiary prevention.
4) Studies aiming to evaluate treatment effects of interventions on specific disorders or symptoms
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9621
kouima@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 Digital Mental Health
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9621
Homepage URL
kouima@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2023 | Year | 07 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This systematic review and meta-analysis examines the effects of non-pharmacological interventions aiming at primary prevention using digital health technologies for mental health conditions, positive mental health, and other work-related outcomes among workers, based on a synthesis of randomized controlled trial studies.
The participants, exposures, comparisons, and outcomes of the studies in this systematic review and meta-analysis are defined as follows: (P) employees/workers, (I) any non-pharmacological interventions aiming at primary prevention using digital health technologies (e.g., exercises, diet, lifestyle, psychological intervention such as cognitive behavioral therapy), (C) any control conditions, (O) mental health conditions, positive mental health, and work-related outcomes.
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058861
