UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an internet-based cognitive behavioral therapy (iCBT) intervention for improving depressive symptoms and preventing depression among nurses in Japan: a protocol for a randomized controlled trial
Acronym	Effects of an internet-based cognitive behavioral therapy (iCBT) intervention for improving depressive symptoms and preventing depression among nurses in Japan: a protocol for a randomized controlled trial
Scientific Title	Effects of an internet-based cognitive behavioral therapy (iCBT) intervention for improving depressive symptoms and preventing depression among nurses in Japan: a protocol for a randomized controlled trial
Scientific Title:Acronym	Effects of an internet-based cognitive behavioral therapy (iCBT) intervention for improving depressive symptoms and preventing depression among nurses in Japan: a protocol for a randomized controlled trial
Region	Japan

Condition
Condition	Depressive symptoms
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 a new developed internet based cognitive-behavioral program on improving depressive symptoms, as primary outcomes, among nurses in Japan. The purpose of the study is to examine its effectiveness on reducing the risk of DSM-5-defined Major Depressive Episode (MDE) and on improving work engagement and work performance, as secondary outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depression severity (assessed by using Beck Depression Inventory-II [BDI-II])
Key secondary outcomes	The onset of MDE (assessed by using the web-version of the WHO-Composite International Diagnostic Interview [WHO-CIDI ver.3.0]) Psychosocial work environment (assessed by using Job Content Questionnaire [JCQ]) Work engagement (assessed by using the Utrecht Work Engagement Scale [UWES]) Performance (assessed by using the WHO Health and Productivity Questionnaire [HPQ]) Sick leave days in the past 3 months Intention to leave their organization during the last month Knowledge and self-efficacy on stress management

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	This study's iCBT program is a 6-module web-based training program that provides stress management skills based on CBT in a manga story. The iCBT program is comprised six modules, each covering a different component of CBT: psychological stress model (in module 1), self-monitoring skills (in module 2), behavioral activation skills (in module 3), cognitive restructuring skills (in module 4 and 5), relaxation skills (in module 5), and problem-solving skills (in module 6).
Interventions/Control_2	Wait list control condition
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Registered nurse 2) Currently employed full-time by the hospital. 3) Can access to the Internet via their own PC, smartphone, or tablet computer
Key exclusion criteria	1) Nurses who are going to take days off for any reasons or leave the hospital during the 6 months study period 2) Practical nurse or nursing aide 3) Non-regular, part-time, or temporary nurses 4) Be diagnosed with a major depressive disorder in the past month (using the web-version of the WHO-CIDI ver.3.0.) 5) Be diagnosed with lifetime bipolar disorder (WHO-CIDI ver.3.0.) 6) Sick leave for 15 or more days in total owing to own health problems during the past three months 7) Those who receive current treatment including psychotherapy from a mental health professional 8) Those who have strong suicidal ideation (Based on the item of Beck Depression Inventory-II (BDI-II) measured by baseline survey)
Target sample size	1050

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norito Kawakami
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Mental Health
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3364
Email	nkawakami@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuto Kuribayashi
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Psychiatric nursing
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo,Japan
TEL	03-5841-3612
Homepage URL
Email	kkuribayashi-jans@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Department of Mental Health/ Psychiatric Nursing, Graduate School of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2018 Year 08 Month 01 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	No longer recruiting
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 07 Month 09 Day
Anticipated trial start date	2018 Year 08 Month 15 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 26 Day
Last modified on	2019 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038220