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UMIN-CTR Clinical Trial |
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Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000006210 |
Receipt No. | R000007341 |
Scientific Title | Stress management and primary prevention of depression among workers |
Date of disclosure of the study information | 2011/09/05 |
Last modified on | 2015/02/22 |
Basic information | ||
Public title | Stress management and primary prevention of depression among workers | |
Acronym | Stress management and primary prevention of depression among workers | |
Scientific Title | Stress management and primary prevention of depression among workers | |
Scientific Title:Acronym | Stress management and primary prevention of depression among workers | |
Region |
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Condition | |||
Condition | Subthreshold depression, depressive episode
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Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of the study is to examine the effectiveness of an internet cognitive-behavioral program for reducing depression and preventing depressive episode, as primary outcomes, among workers with subthreshold depression, in comparison with treatment-as-usual (TAU) (which is minimal contact through in-house Employers Assistance Program (EAP)). The purpose of the study is to examine its effectiveness for increasing work productivity, reducing sick leave, and increasing work engagement, as secondary outcomes.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1) Depression severity as measured by Beck Depression Inventory-II (BDI2) at 3 and 6 months post-randomization
2) Duration before the onset of major/minor depressive episode measured by the web-based self-rated CIDI after randomization until 6 month follow-up |
Key secondary outcomes | 1) Severity of depression measured by K6
2) Work performance measured by WHO Health and Performance Questionnaire (HPQ) 3) Sick leave days in the past 3 months 4) Work Engagement measured by Utrecht Work Engagement Scale (UWES-9) 5) 24-item Dysfunctional Attitude Scale (DAS-24-J) 6) Knowledge and self-efficacy on stress management |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | A weekly, 6-session internet learning program which provides psychoeducation of stress management based on cognitive-behavioral technique
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Interventions/Control_2 | Treatment as usual through the in-house Employees Assistance Program
Monthly e-mail contact to provide non-CBT stress management tips |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Age 20-60 at study entry
2) Men and women 3) Currently employed full-time by the business company 4) K6 scores greater than or equal to 5 at screening (while a sub-analysis will be done for all subjects including those with K6 scores of 0-4, as well 5) Can access the Internet via a PC at home or at workplace |
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Key exclusion criteria | 1) Non-regular or part-time employees
2) Sick leave for 15 or more days for a physical or mental condition in the past 3 months 3) Current treatment for a mental health problem from a mental health professional 4) Major depressive episode in the past month, as ascertained by web-based CIDI 5) Lifetime history of bipolar disorder, as ascertained by CIDI |
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Target sample size | 262 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, University of Tokyo | ||||||
Division name | Mental Health | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | +81-3-5841-3521 | ||||||
norito@m.u-tokyo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Graduate School of Medicine, University of Tokyo | ||||||
Division name | Mental Health | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | +81-3-5841-3364 | ||||||
Homepage URL | |||||||
icbt@m.u-tokyo.ac.jp |
Sponsor | |
Institute | Department of Mental Health, Graduate School of Medicine, University of Tokyo |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Scientific Research (KAKENHI) |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | The iCBT program showed a significant intervention effect on BDI-II (t=-1.99, p<0.05) with small effect sizes (Cohen's d: -0.16, 95% Confidence Interval: -0.32 to 0.00, at six-month follow-up).
Publication: Imamura K, Kawakami N, Furukawa TA, Matsuyama Y, Shimazu A, Umanodan R, Kawakami S, Kasai K. Effects of an Internet-based cognitive behavioral therapy (iCBT) program in Manga format on improving subthreshold depressive symptoms among healthy workers: a randomized controlled trial. PLoS One. 2014 May 20;9(5):e97167. doi: 10.1371/journal.pone.0097167 |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | At the 12-month follow-up (beyond this protocol), the intervention group had a significantly lower incidence of major depressive episode at the 12-month follow-up than the control group (Log-rank chi2=7.04, p<0.01).
Publication: Imamura K, Kawakami N, Furukawa TA, Matsuyama Y, Shimazu A, Umanodan R, Kawakami S, Kasai K. Does Internet-based cognitive behavioral therapy (iCBT) prevent major depressive episode for workers? A 12-month follow-up of a randomized controlled trial. Psychol Med. 2015 Jan 7:1-11. [Epub ahead of print] |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007341 |