UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043897 |
|---|---|
| Receipt number | R000050125 |
| Scientific Title | A randomized controlled trial of effect of SMART-CBT on improving depression and psychological distress among workers |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2021/10/12 09:09:31 |
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Basic information
Public title
A study of primary prevention of depression by a stress management among workers
Acronym
A study of primary prevention of depression by a stress management among workers
Scientific Title
A randomized controlled trial of effect of SMART-CBT on improving depression and psychological distress among workers
Scientific Title:Acronym
A randomized controlled trial of effect of SMART-CBT on improving depression and psychological distress among workers
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of a newly developed AI-supported cognitive behavioral therapy stress management program (SMART-CBT) on depression and psychological distress among workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms of depression (BDI-II) (3- and 6-month)
Key secondary outcomes
Psychological distress (K6) (3- and 6-month)
Fear of COVID-19 (FCV-19) (3- and 6-month)
Sick leave (3- and 6-month)
Major depressive episode (self-report MINI) (12 month, while the data will be collected at 6- and 12-month follow-ups)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
AI-supported Internet cognitive behavioral stress management program (leaning for 6 weeks; accessible during additional 4 weeks (10 weeks in total))
Interventions/Control_2
No treatment (TAU)
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Adults (20-60 years old)
(2) Full-time employees
(3) Those who have an access the Internet via PC, smartphone, or tablet.
Key exclusion criteria
(1) not on long-term sick leave or maternity/childcare leave, or temporary ray-off at the recruitment
(2) no sick leave of 15 days or more in the past 3 months
(3) not receiving treatment from mental health professionals.
(4) No major depressive episode in the past month (based on the self-report MINI)
(5) Not business owner, self-employed, freelance, or part-time.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Norito |
| Middle name | Kawakami |
| Last name | Kawakami |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413521
norito@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 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
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413521
Homepage URL
http://plaza.umin.ac.jp/heart/
norito@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
JSPS/Ministry of Education, Sports, and Culture, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kitasato University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address
Graduate School of Medicine, The University of 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
株式会社マクロミル
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 31 | 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
1296
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 12 | Day |
Last modified on
| 2021 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050125
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| Registered date | File name |
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