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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034927
Receipt No. R000039814
Scientific Title Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Date of disclosure of the study information 2019/01/01
Last modified on 2019/05/20

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Basic information
Public title Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Acronym Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Scientific Title Effectiveness Study of Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Scientific Title:Acronym Internet based Cognitive Behavioral Therapy for insomnia: a three-arm randomized controlled trial
Region
Japan

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

Objectives
Narrative objectives1 To examine effectiveness of self-help ICBT without email support for non-clinical adult with insomnia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PSQI(Pittsburgh Sleep Quality Index)
Key secondary outcomes AIS(Athens Insomnia Scale)
GAD-7(Generalized Anxiety Disorder)
PHQ-9(Patient Health Questionnaire)
CES-D(Center for Epidemiologic Studies Depression Scale)
GTS(General Trust Scale)
CCI(consumer confidence index)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Internet-based Cognitive Behavioral Therapy program
Interventions/Control_2 Three Good Things
Interventions/Control_3 Waiting
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Insomnia symptom(AIS score of 10 and above, PSQI score of 6 and above)
Insomnia cause at least 3 nights a week and last for at least 3 months
Subjects with an internet environment
Subjects who can understand Japanese explanation and agree with online consent by voluntary free will
Key exclusion criteria Moderate or severe anxiety symptom(GAD7 score of 10 and above)
Moderate or severe depressive symptom(GAD7 score of 10 and above)
Alcohol dependence
Drug dependence
Suicidal ideation(PHQ9 Question 2 of 2 and above)
Cerebral organic disease such as Sleep apnea syndrome, restless legs syndrome, epilepsy, dementia, and cerebrovascular disorders
Diagnosis of severe progressive physical disorders such as cancer and heart failure, and under medical treatment
Subjects who are not permitted by primary doctor to participate in this research, for psychological symptoms medication including insomnia
Subjects who do not go to bed twenty to two o'clock(night shift worker)
Target sample size 180

Research contact person
Last name of lead principal investigator
1st name Shimizu
Middle name
Last name Eiji
Organization Chiba University Graduate School of Medicine
Division name Department of Cognitive Behavioral Physiology, Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
Zip code 260-8670
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
1st name of contact person
1st name Sutoh
Middle name
Last name Chihiro
Organization Chiba University Graduate School of Medicine
Division name Department of Cognitive Behavioral Physiology
Zip code 260-8670
Address 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
TEL 043-226-2027
Homepage URL
Email neurophys1@ml.chiba-u.jp

Sponsor
Institute Chiba University Graduate School of Medicine,
Department of Cognitive Behavioral Physiology Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
Institute
Department

Funding Source
Organization Reseach Institute of Economy, Trade and Industry (RIETI)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba university hospital clinical research center
Address 1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
Tel 043-222-7171
Email chibacrc@mac.com

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 千葉大学大学院医学研究院認知行動生理学,子どものこころの発達教育研究センター,医学部附属病院認知行動療法センター

Other administrative information
Date of disclosure of the study information
2019 Year 01 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
2018 Year 12 Month 31 Day
Date of IRB
2019 Year 02 Month 08 Day
Anticipated trial start date
2019 Year 03 Month 31 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 18 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039814

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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