UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036572 |
|---|---|
| Receipt number | R000041638 |
| Scientific Title | Effect of App for tailored brief behavioral therapy for workers with insomnia on insomnia-related symptoms, social disabilities, and work productivity: A single-blind randomized controlled trial |
| Date of disclosure of the study information | 2019/04/22 |
| Last modified on | 2019/04/22 11:32:16 |
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Basic information
Public title
Effect of Sleep care Application on insomnia: a randomized controlled trial
Acronym
Effect of Sleep care App on insomnia: a randomized controlled trial
Scientific Title
Effect of App for tailored brief behavioral therapy for workers with insomnia on insomnia-related symptoms, social disabilities, and work productivity: A single-blind randomized controlled trial
Scientific Title:Acronym
Effect of Sleep care App on insomnia: a randomized controlled trial
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine an effect of the fully-automated and individually tailored brief behavior therapy for insomnia (bBTi) for 2 weeks for workers with insomnia on insomnia-related symptoms, social disabilities, and worker productivity compared with manualized bBTi, self-monitoring, and wait-list control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Insomnia Severity Index
Sheehan Disability Scale
Key secondary outcomes
Dysfunctional Beliefs and Attitudes about Sleep Scale
Ford Insomnia Response to Stress Test
Work Limitation Quastionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Tailored CBTI;
Interventions/Control_2
Manualized CBTI
Interventions/Control_3
Self-monitoring
Interventions/Control_4
wait-list
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) workers who aged 20 years or older, (2) total score of Insomnia Severity Index (ISI) > 7, (3) complaining with initial, middle, and/or terminal insomnia, and (4) performing work during the day.
Key exclusion criteria
(1) having a medical history of posttraumatic stress disorder, depressive disorders, and sleep disorders without insomnia, (2) reporting suicidal ideation, (3) receiving pharmacological and/or psychological treatments, (4) sift-workers, and (5) likelihood of causing serious risk by sleep loss (e.g., traffic accident).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei University
Division name
Department of Psychological Counseling, Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3961-5276
okajima-i@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei University
Division name
Department of Psychological Counseling, Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
TEL
03-3961-5276
Homepage URL
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
NEC Solution Innovators
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Kasei University
Address
1-18-1 Kaga, Itabashi-ku, Tokyo
Tel
03-3961-5276
isa.okajima@gmail.com
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 | 04 | 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
92
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Submitting the paper to the journal.
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
| 2017 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 24 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041638
