UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013401
Receipt No. 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 2021/03/22

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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
Email 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
Email okajima@somnology.com

Sponsor
Institute Neuropsychiatric Research Institute
Institute
Department

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
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 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
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015348

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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