UMIN-CTR Clinical Trial

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

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	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

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	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
Email	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
Email	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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007341

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