UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044581 |
|---|---|
| Receipt number | R000049907 |
| Scientific Title | A Single-Arm Study of an Internet Based Self-Help Cognitive Behavioral Therapy Program for Insomnia |
| Date of disclosure of the study information | 2021/06/17 |
| Last modified on | 2024/01/05 15:27:02 |
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Basic information
Public title
A Single-Arm Study of an Internet Based Self-Help Cognitive Behavioral Therapy Program for Insomnia
Acronym
A Single-Arm Trial of Internet Based Cognitive Behavioral Therapy for Insomnia
Scientific Title
A Single-Arm Study of an Internet Based Self-Help Cognitive Behavioral Therapy Program for Insomnia
Scientific Title:Acronym
A Single-Arm Trial of Internet Based Cognitive Behavioral Therapy for Insomnia
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm in a single-arm study the safety and feasibility of using the Internet Self-Help Cognitive Behavioral Therapy program in a multi-center medical center to safely reduce insomnia symptoms in patients with insomnia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Insomnia Severity Index
Key secondary outcomes
Patient Health Questionnaire-9
Generalized Anxiety Disorder-7
Athens Insomnia Scale
Sleep Onset Latency
Total Sleep Time
Wake After Sleep Onset
Number of Awakenings
Sleep Efficiency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Internet-based self-help Cognitive Behavioral Therapy program
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
It conforms to the diagnostic criteria for insomnia according to DSM-5.
Insomnia of more than mild severity. (ISI score of 8 or higher)
Aged between 18 and 70 years at the time of consent.
Have a computer environment that allows them to take the ICBT.
Have written consent from the patient or a substitute.
Key exclusion criteria
Have a clinically significant psychiatric disorder that would preclude continued participation in the study.
Has a clinically significant progressive physical illness that would preclude continued participation in the study.
Have symptoms that are suspected to be side effects of sleeping pills.
They are using unapproved drugs in Japan.
Difficulty in contacting the investigator.
The investigator judges other conditions to be inappropriate for the safe conduct of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
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
neurophys1@ml.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
daisuke-sato@umin-ac.jp
Sponsor or person
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
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akita University School of Medicine/Department of Neuropsychiatry Section of Neuro and Locomotor Science
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
YES
Study ID_1
2667
Org. issuing International ID_1
Independent Ethics Committee, Akita University Graduate School of Medicine and Faculty of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）、秋田大学医学部附属病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | 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
9
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
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049907
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