UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038224 |
|---|---|
| Receipt number | R000043571 |
| Scientific Title | Randomized controlled trial of the effectiveness of cognitive behavioral therapy for improving sleep EEG measured with the simple electroencephalograph in the workplace |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2019/10/07 14:55:08 |
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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
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
kiyomi_nakamura@global.komatsu
Sponsor or person
Institute
komatsu
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043571
