UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033521 |
|---|---|
| Receipt number | 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 15:32:29 |
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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
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
kkuribayashi-jans@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038220
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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