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Recruitment status Completed
Unique ID issued by UMIN UMIN000015172
Receipt No. R000017642
Scientific Title The effect of cognitive behavioral therapy for comorbid insomnia: a meta-analysis
Date of disclosure of the study information 2014/09/17
Last modified on 2016/10/19

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Basic information
Public title The effect of cognitive behavioral therapy for comorbid insomnia: a meta-analysis
Acronym A meta-analysis of CBT-I for comorbid insomnia
Scientific Title The effect of cognitive behavioral therapy for comorbid insomnia: a meta-analysis
Scientific Title:Acronym A meta-analysis of CBT-I for comorbid insomnia
Region
Japan

Condition
Condition comorbid insomnia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate a meta-analysis of cognitive behavioral therapy for comorbid insomnia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes sleep diary
self-rating scale for insomnia severity
Key secondary outcomes main disease-related scales
objective sleep parameters

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria randomized controlled trial for patients with comorbid insomnia
Key exclusion criteria non-randomized controlled trial
statistical data required on meta-analysis (e.g., mean and SD) does not described in manuscript.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isa Okajima
Organization Neuropsychiatric Research Institute
Division name Japan Somnology Center
Zip code
Address 1-24-10 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL 03-3374-9112
Email okajima@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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Society for the promotion of sciense
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 17 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
2014 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 17 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information A meta-analysis on the RCT of CBT-I for comorbid insomnia

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017642


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