UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044016 |
|---|---|
| Receipt number | R000049982 |
| Scientific Title | A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control |
| Date of disclosure of the study information | 2021/04/22 |
| Last modified on | 2021/11/04 12:53:56 |
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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
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
neurophys1@ml.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049982
