UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023008 |
|---|---|
| Receipt number | R000026522 |
| Scientific Title | Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2017/01/05 13:54:42 |
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Basic information
Public title
Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial
Acronym
UTSeL study
Scientific Title
Effects of a web-based self-care intervention program on improving depressive symptoms and return to work self-efficacy for sick leave employees: a randomized controlled trial
Scientific Title:Acronym
UTSeL study
Region
| Japan |
Condition
Condition
Mild and moderate depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of a web-based self-care program on improving depressive symptoms and return to work self-efficacy for sick leave employees with depression compared to those with care as usual. The other purpose of this study is to examine its effectiveness on improving general self-efficacy, changing of locus of control and coping and improving dysfunctional attitude as secondary outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity and symptoms of depression measured by BDI-2 and QIDS-J and return to work self-efficacy (RTW-SE) measured by RTW-SE scale one month after the randomization
Key secondary outcomes
1) General self-efficacy (General self-efficacy scale)
2) Locus of control (Locus of control scale)
3) Coping (Brief Scales for Coping Profile)
4) Dysfunctional attitude (Dysfunctional attitude scale)
5) Life orientation (Life orientation test)
6) 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 not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A web-based self learning program which provides process of return to work, case study, skills to maintain life rhythm, psychoeducation of stress management based on cognitive behavioral therapy and one's own career
Interventions/Control_2
Care as usual
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) Sick leave workers with depression
4) can access the internet via a PC, a smart phone or a tablet
Key exclusion criteria
1) Patient with severe depression
2) Patient who quit one's job
3) Patient who has more than two times of sick leave episodes
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Shimazu |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Mental Health
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5841-3612
ashimazu@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichi Sakan |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Mental Health
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-80-3000-1321
Homepage URL
shunny0614@gmail.com
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 07 | Month | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | 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
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026522
