UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058948 |
|---|---|
| Receipt number | R000067415 |
| Scientific Title | Text-message intervention for distress at work: Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/08/31 23:46:41 |
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Basic information
Public title
Research of a text-message intervention for distress at work
Acronym
An intervention for distress at work
Scientific Title
Text-message intervention for distress at work: Randomized Controlled Trial
Scientific Title:Acronym
Text-message intervention for distress at work: RCT
Region
| Japan |
Condition
Condition
Distress in work
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although text-based interventions for stress reduction are often based on cognitive behavioral therapy, there is a lack of evidence on the effectiveness of high-frequency delivery. Accordingly, the purpose of this study is to investigate the impact of a daily, five-minute text message intervention, designed to be read quickly, on the mental well-being of employees.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measure is the K6 mental health checklist.
Key secondary outcomes
Secondary outcome measures include the Patient Health Questionnaire-9 (PHQ-9), the WHO-5 Well-being Index, the Generalized Anxiety Disorder-7 (GAD-7), and the Perceived Stress Scale-4 (PSS-4).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Text messages providing intervention techniques based on stress literacy, positive psychology, and cognitive behavioral therapy.
Interventions/Control_2
Sham/Placebo message
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Local government employees in Kagoshima Prefecture, between 18 and 65 years old, with no planned transfer, leave of absence, or change in employment status during the current study.
Key exclusion criteria
Exclusion criteria include: women with a high risk of suicide, those who are pregnant, may become pregnant, or are within 28 days postpartum, and individuals for whom continued study participation is difficult due to psychosis or other severe mental disorders. However, individuals with conditions such as depression are not excluded if they have high motivation and a clear need, are consistently receiving medical treatment, and have the permission of their primary physician. Other individuals deemed unsuitable by the researchers are also excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakamura |
Organization
Kagoshima University
Division name
Department of Psychiatry, Graduate School of Medical and Dental Sciences
Zip code
8908520
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
TEL
099-275-5707
nakamu36@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Kagoshima University Hospital
Division name
Division of Clinical Psychology
Zip code
890-8520
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
TEL
099-275-5707
Homepage URL
k2782199@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Non.
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
Sakuragaoka Campus Clinical Research Ethics Committee, Kagoshima University
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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
| 2025 | Year | 09 | Month | 30 | 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
| 2025 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067415
