UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013401 |
|---|---|
| Receipt number | R000015348 |
| Scientific Title | Efficacy of an internet-based cognitive behavioral therapy for insomnia: a randomized controlled trial |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2023/02/15 16:12:01 |
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Basic information
Public title
Efficacy of an internet-based cognitive behavioral therapy for insomnia: a randomized controlled trial
Acronym
Internet-based treatment for insomnia
Scientific Title
Efficacy of an internet-based cognitive behavioral therapy for insomnia: a randomized controlled trial
Scientific Title:Acronym
Internet-based treatment for insomnia
Region
| Japan |
Condition
Condition
Chronic insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of internet-based cognitive behavior therapy for chronic insomnia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
sleep diary
Insomnia Severity Index
Key secondary outcomes
Beck Depression Inventory
Spence-Essau Anxiety Scale
Ford Insomnia Response to Stress Test
Sheehan Disability Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy
1. sleep diary
2. sleep hygiene
3. sleep scheduling
4. progressive muscle relaxation
Interventions/Control_2
Control
1. sleep diary
2. sleep hygiene
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Meeting the criteria of chronic insomnia according to the second edition of the International Classification of sleep disorders
2. a score of 8 or greater for insomnia as measured by the ISI.
Key exclusion criteria
1. insomnia due to medical or psychiatric disorders or pharmaceutical causes and 2. the existence of other sleep disorders
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Inoue |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3351-6141
inoue@somnology.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okajima Isa |
Organization
Neuropsychiatric Research Institute
Division name
Japan Somnology Center
Zip code
Address
1-24-10 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-3374-9112
Homepage URL
okajima@somnology.com
Sponsor or person
Institute
Neuropsychiatric Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Jikei university school of medicine; Akita University; Hiroshima University, National Center of Neurology and Psychiatry, Tokyo Women's Medical University, Gifu Mates Sleep Center, Wellness Boyodai Hospital
Name of secondary funder(s)
Japan Society for the Promotion of Science
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
東京慈恵会医科大学（東京都），広島大学（広島県），秋田大学（秋田県），国立精神・神経医療研究センター（東京都），東京女子医科大学（東京都），岐阜メイツ睡眠障害治療センター（岐阜県），ウェルネス望洋台医院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015348
