UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006210 |
|---|---|
| Receipt number | 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 12:51:15 |
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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
| Japan |
Condition
Condition
Subthreshold depression, depressive episode
Classification by specialty
| Psychiatry | Adult |
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.
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
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
| Behavior,custom |
Interventions/Control_1
A weekly, 6-session internet learning program which provides psychoeducation of stress management based on cognitive-behavioral technique
Interventions/Control_2
Treatment as usual through the in-house Employees Assistance Program
Monthly e-mail contact to provide non-CBT stress management tips
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) 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
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
Target sample size
262
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norito Kawakami |
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
| 1st name | |
| Middle name | |
| Last name | Kotaro Imamura |
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 or person
Institute
Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
| 2011 | Year | 09 | Month | 05 | Day |
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
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
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
| 2011 | Year | 08 | Month | 22 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007341
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| Registered date | File name |
| Research case data | |
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