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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033521
Receipt No. R000038220
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
Date of disclosure of the study information 2018/08/01
Last modified on 2019/07/27

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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

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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