UMIN-CTR Clinical Trial

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
Last 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
1st 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