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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014146
Receipt No. R000016466
Scientific Title Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on preventing major depressive episode among workers: a large scale randomized controlled trial
Date of disclosure of the study information 2014/07/31
Last modified on 2017/06/05

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Basic information
Public title Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on preventing major depressive episode among workers: a large scale randomized controlled trial
Acronym Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on preventing major depressive episode among workers: a large scale randomized controlled trial
Scientific Title Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on preventing major depressive episode among workers: a large scale randomized controlled trial
Scientific Title:Acronym Effects of an internet-based cognitive behavioral therapy (iCBT) intervention on preventing major depressive episode among workers: a large scale randomized controlled trial
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 preventing depressive episode, as primary outcome, among workers, 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 subthreshold depressive symptoms, psychological distress, 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) Duration before the onset of major depressive episode measured by the web-based self-rated CIDI after randomization until 6 and 12 month follow-up
Key secondary outcomes 1) Severity of subthresholddepression measured by BDI-II
2) Severity of depression measured by K6
3) Work performance measured by WHO Health and Performance Questionnaire (HPQ)
4) Sick leave days in the past 3 months
5) Work Engagement measured by Utrecht Work Engagement Scale (UWES-9)
6)time preference
7) QOL measured by EQ-5D
8)Original questions

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 adjustment factor in dynamic allocation.
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) 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 8272

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 nkawakami@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 +81-3-5841-3522
Homepage URL
Email icbt@m.u-tokyo.ac.jp

Sponsor
Institute Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department

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
2014 Year 07 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
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
2014 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2017 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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