UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and effectiveness verification of sleep education program utilizing group cognitive behavioral therapy in workplace.
Title of the study (Brief title)	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	Yukari Nakada
Organization	Shiga University of Medical Science
Division name	Department of Psychiatry
Address	Shiga University of Medical Science Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL	077-548-2111
Email	ynakada0329@gmail.com

Public contact
Name of contact person	Yukari Nakada
Organization	Shiga University of Medical Science
Division name	Department of Psychiatry
Address	Shiga University of Medical Science Seta Tsukinowa-cho, Otsu City, Shiga, 520-2192 JAPAN
TEL	077-548-2111
Homepage URL
Email	ynakada0329@gmail.com

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030604