UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026650 |
|---|---|
| Receipt number | R000030604 |
| Scientific Title | Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace. |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2017/03/22 17:13:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace.
Acronym
Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace.
Scientific Title
Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace.
Scientific Title:Acronym
Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace.
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a sleep education program that utilizes collective cognitive behavioral therapy in the workplace and to verify the physical and mental health effects of workers by utilizing mobile activity amount meter with communication function .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISI,AIS,PHQ-9,SF-8,health check data,Mobile activity data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep health education
Interventions/Control_2
Document education
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
employee
Key exclusion criteria
nothing
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Nakada |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
Address
Shiga University of Medical Science Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL
077-548-2111
ynakada0329@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukari Nakada |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
Address
Shiga University of Medical Science Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL
077-548-2111
Homepage URL
ynakada0329@gmail.com
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
| 2017 | Year | 03 | Month | 22 | 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
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | 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
| 2017 | Year | 03 | Month | 22 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030604
