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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023999
Receipt No. R000027629
Scientific Title The randomized controlled trial on the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Date of disclosure of the study information 2016/09/12
Last modified on 2018/05/21

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Basic information
Public title The randomized controlled trial on the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Acronym Mobile-app delivered cognitive behavioral therapy for insomnia
Scientific Title The randomized controlled trial on the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Scientific Title:Acronym Mobile-app delivered cognitive behavioral therapy for insomnia
Region
Japan

Condition
Condition Insomnia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the efficacy of mobile-app delivered cognitive behavioral therapy for insomnia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Athens Insomnia Scale
Key secondary outcomes Sleep diary
Quick Inventory of Depressive Symptomatology (QIDS)
Actigraph
Epwarth sleepiness scale
psychomotor vigilance task (PVT)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Mobile-app delivered cognitive behavioral therapy (8 weeks)
1. sleep diary
2. sleep hygiene
3. sleep restriction therapy
4. stimulus control therapy
5. cognitive therapy
6. relaxation
7. actigraph
Interventions/Control_2 Control (8 weeks)
1. sleep diary
2. sleep hygiene
3. actigraph
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

Not applicable
Gender Male and Female
Key inclusion criteria Score of the Athens insomnia scale is 6 points or more
Key exclusion criteria Unable to use smartphone
circadian rhythm disorder
sleep apnea syndrome
Restless legs syndrome
hypersomnia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taro Ueno
Organization Neuropsychiatric Research Institute
Division name Seiwa Hospital
Zip code
Address Bentencho 91, Shinjuku, Tokyo
TEL +81-3-3260-9171
Email t-ueno@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Ueno
Organization Neuropsychiatric Research Institute
Division name Seiwa Hospital
Zip code
Address Bentencho 91, Shinjuku, Tokyo
TEL +81-3-3260-9171
Homepage URL
Email t-ueno@umin.ac.jp

Sponsor
Institute Neuropsychiatric Research Institute
Institute
Department

Funding Source
Organization New Energy and Industrial Technology Development Organization (NEDO)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kuwamizu Hospital
Name of secondary funder(s) Sustainable Medicine, Inc.
DeSC Healthcare, Inc.

IRB Contact (For public release)
Organization
Address
Tel
Email

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 晴和病院(東京都)、くわみず病院(熊本県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 12 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 Completed
Date of protocol fixation
2015 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 10 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027629

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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