UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control
Acronym	A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education
Scientific Title	A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control
Scientific Title:Acronym	A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education
Region	Japan

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

Objectives
Narrative objectives1	To test the efficacy of a non-invasive, self-medicating, email-supported, self-help intervention for adults with insomnia symptoms but not receiving medication. A randomized controlled trial will be conducted with (1) a study treatment group (Internet cognitive behavioral therapy with the addition of the "Three Good Things" exercise (TGT)) and (2) a control group (psychological education) as the self-help type intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	PSQI; Pittsburgh Sleep Quality Index
Key secondary outcomes	SOL; Sleep Onset Latency TST; Total Sleep Time SE; Sleep Efficiency AIS; Athens Insomnia Scale GAD-7; Generalized Anxiety Disorder ISI; Insomnia Severity Index PHQ-9; Patient Health Questionnaire CES-D; Center for Epidemiologic Studies Depression Scale EQ-5D-5L; EuroQOL - 5 dimensions - 5 level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Internet-based Cognitive Behavioral Therapy program Three Good Things Exercise
Interventions/Control_2	Sleep Hygiene Education
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Insomnia symptom(PSQI score of 6 and above, AIS score of 6 and above, and ISI score of 8 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	405

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Shimizu
Organization	Chiba University Graduate School of Medicine Research Center for Child Mental Development Cognitive Behavioral Center of Chiba University Hospital
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
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Sato
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
Institute
Department

Funding Source
Organization	Chiba Foundation for Health Promotion & Disease Prevention
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 22 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	405
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	2020 Year 12 Month 25 Day
Date of IRB	2021 Year 04 Month 19 Day
Anticipated trial start date	2021 Year 06 Month 25 Day
Last follow-up date	2021 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 22 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049982