Unique ID issued by UMIN | UMIN000044581 |
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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 |
A Single-Arm Study of an Internet Based Self-Help Cognitive Behavioral Therapy Program for Insomnia
A Single-Arm Trial of Internet Based Cognitive Behavioral Therapy for Insomnia
A Single-Arm Study of an Internet Based Self-Help Cognitive Behavioral Therapy Program for Insomnia
A Single-Arm Trial of Internet Based Cognitive Behavioral Therapy for Insomnia
Japan |
Insomnia
Psychiatry | Not applicable |
Others
NO
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.
Safety
Confirmatory
Explanatory
Phase IV
Insomnia Severity Index
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment | Behavior,custom |
Internet-based self-help Cognitive Behavioral Therapy program
18 | years-old | <= |
70 | years-old | >= |
Male and Female
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.
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.
30
1st name | Eiji |
Middle name | |
Last name | Shimizu |
Chiba University Graduate School of Medicine
Department of Cognitive Behavioral Physiology, Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
260-8670
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
043-226-2027
neurophys1@ml.chiba-u.jp
1st name | Daisuke |
Middle name | |
Last name | Sato |
Chiba University Graduate School of Medicine
Department of Cognitive Behavioral Physiology
260-8670
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8670, Japan
043-226-2027
daisuke-sato@umin-ac.jp
Chiba University Graduate School of Medicine, Department of Cognitive Behavioral Physiology Research Center for Child Mental Development, Cognitive Behavioral Center of Chiba University Hospital
None
Other
Akita University School of Medicine/Department of Neuropsychiatry Section of Neuro and Locomotor Science
Chiba university hospital clinical research center
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
043-222-7171
chibacrc@mac.com
YES
2667
Independent Ethics Committee, Akita University Graduate School of Medicine and Faculty of Medicine
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)
2021 | Year | 06 | Month | 17 | Day |
Unpublished
9
Completed
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 04 | Month | 19 | Day |
2021 | Year | 06 | Month | 30 | Day |
2023 | Year | 07 | Month | 31 | Day |
2024 | Year | 01 | Month | 31 | Day |
2024 | Year | 02 | Month | 28 | Day |
2024 | Year | 03 | Month | 31 | Day |
2021 | Year | 06 | Month | 17 | Day |
2024 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049907
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