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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036572
Receipt No. 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

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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
Email 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
Email okajima-i@tokyo-kasei.ac.jp

Sponsor
Institute Tokyo Kasei University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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