UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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