UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023999 |
|---|---|
| Receipt number | 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 10:51:41 |
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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
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
t-ueno@umin.ac.jp
Sponsor or person
Institute
Neuropsychiatric Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027629
