UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of the effectiveness of cognitive behavioral therapy for improving sleep EEG measured with the simple electroencephalograph in the workplace
Acronym	Effectiveness of cognitive behavioral therapy for improving sleep electroencephalogram in the workplace
Scientific Title	Randomized controlled trial of the effectiveness of cognitive behavioral therapy for improving sleep EEG measured with the simple electroencephalograph in the workplace
Scientific Title:Acronym	Effectiveness of cognitive behavioral therapy for improving sleep electroencephalogram in the workplace
Region	Japan

Condition
Condition	Insomnia
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of I-CBT for sleep electroencephalogram improvement
Basic objectives2	Others
Basic objectives -Others	To examine the correlation between changes in sleep EEG and various questionnaires
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Each measurement value of portable 1-channel electroencephalograph (sleep scope)
Key secondary outcomes	ISI(insomnia severity index) ESS(Epworth sleepiness scale) UWES(Utrecht Work Engagement Scale) WFun(Work Functioning Impairment Scale) K6

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Cognitive Behavioral Therapy program for insomnia
Interventions/Control_2	waiting
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	18 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Employees who met all of the following 1) to 4) in the 2019 stress diagnosis and obtained consent for the purpose of this study 1) Questions about sleep Employees who choose almost 'always' or 'frequently' in response to the question not sleep well 2) Questions regarding business engagement Employees who chose 'No' or 'Slightly different' for I feel full of energy when I work. 3) Employees who chose 'No' or 'Slightly different' in the 'Melancholy' question (2) Among the employees in (1), employees with sleep scopes, low delta power, and low sleep efficiency
Key exclusion criteria	subjects who are determined to be highly stressed by the stress check
Target sample size	30

Research contact person
Name of lead principal investigator	1st name tatsuhiko Middle name Last name hara
Organization	Komatsu
Division name	Health promotion center Osaka Health Care Office
Zip code	573-1011
Address	3-1-1, ueno, Hirakata-city, osaka, 573-1011, Japan
TEL	080-4347-2047
Email	tatsuhiko_th_hara@global.komatsu

Public contact
Name of contact person	1st name Kiyomi Middle name Last name Nakamura
Organization	Komatsu
Division name	Health promotion center Osaka Health Care Office
Zip code	573-1011
Address	3-1-1, ueno, Hirakata-city, osaka, 573-1011, Japan
TEL	080-4347-2047
Homepage URL
Email	kiyomi_nakamura@global.komatsu

Sponsor
Institute	komatsu
Institute
Department

Funding Source
Organization	komatsu
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	komatsu
Address	3-1-1, ueno, Hirakata-city, osaka, 573-1011, Japan
Tel	080-4347-2047
Email	tatsuhiko_th_hara@global.komatsu

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	2019 Year 10 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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 18 Day
Date of IRB	2019 Year 09 Month 18 Day
Anticipated trial start date	2019 Year 09 Month 18 Day
Last follow-up date	2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 07 Day
Last modified on	2019 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043571