UMIN-CTR Clinical Trial

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 Norito Middle name Last name Kawakami
Organization	Graduate School of Medicine, University of Tokyo
Division name	Department of Mental Health
Zip code	1130033
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 Kotaro Middle name Last name Imamura
Organization	Graduate School of Medicine, University of Tokyo
Division name	Department of Mental Health
Zip code	1130033
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	Office for Human Research Studies (OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel	03-5841-0818
Email	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

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	2013 Year 10 Month 03 Day
Anticipated trial start date	2015 Year 02 Month 23 Day
Last follow-up date	2025 Year 12 Month 31 Day
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	2021 Year 12 Month 13 Day

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