UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052911 |
|---|---|
| Receipt number | R000060371 |
| Scientific Title | Brief cognitive behavioral therapy for insomnia provided by healthcare workers: A protocol of a multi-center randomized controlled trial |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/02/21 09:23:44 |
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Basic information
Public title
Efficacy of Reasonable Access to Brief Behavioral Insomnia Treatment
Acronym
RABBIT Study
Scientific Title
Brief cognitive behavioral therapy for insomnia provided by healthcare workers: A protocol of a multi-center randomized controlled trial
Scientific Title:Acronym
Effectiveness of Brief Cognitive Behavioral Therapy for Insomnia
Region
| Japan |
Condition
Condition
chronic insomnia
Classification by specialty
| Neurology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of brief cognitive-behavioral therapy provided by healthcare workers in chronic insomniacs in a multicenter, randomized, parallel-group study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ISI(8 weeks post-intervention)
Key secondary outcomes
ISI(12 weeks post-intervention)
EQ-5D-5L/PAQ9/GAD7/ST/WACO/TST/SE(8 weeks and 12 weeks post-intervention)
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
Intervention is a brief cognitive behavioral therapy with 2-week intervals, a total of 3 interviews, each lasting about 15 minutes. The main technique is the sleep scheduling method. Sleep assessment sheets, educational sheets, and sleep record sheets are utilized.
Interventions/Control_2
The control group will receive the usual treatment for insomnia by a physician. A simple pamphlet is used for lifestyle guidance.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Meets the diagnostic criteria for chronic insomnia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
2.Score of 8 or more on the Insomnia Severity Index (ISI).
3.Is being treated with sleeping medication or is not taking sleeping medication at his/her request.
4.Other psychotropic medications have been stable for the past 3 months and are not expected to change until 12 weeks after the start of the study (note: sleeping medications can be reduced or discontinued).
Key exclusion criteria
1.The primary illness or complication is a physical illness and the patient is in severe physical distress such as pain, dyspnea, etc.
2.Patients with psychiatric disorders other than depression and anxiety such as schizophrenia, bipolar disorder, dementia, substance dependence, personality disorder, eating disorder, and intellectual developmental disorder (if diagnosed as moderate or higher). 2) Patients with depression and anxiety and with severe symptoms such as suicidal ideation.
3.The patient is engaged in shift work involving night shifts (shift workers).
4.Has serious problems in his/her life (e.g., harassment) that prevent him/her from devoting himself/herself to treatment.
5.Has difficulty reading and writing Japanese.
6.Other problems that make it difficult for the attending physician to participate in this study.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Makie |
| Middle name | |
| Last name | Nagai |
Organization
University of Toyama
Division name
Department of Public Health, Faculty of Medicine
Zip code
930-0194
Address
SUGITANI 2630, Toyama, Toyama-shi, Japan
TEL
080-8850-0489
m-nagai@amall.co.jp
Public contact
Name of contact person
| 1st name | Makie |
| Middle name | |
| Last name | Nagai |
Organization
University of Toyama
Division name
Department of Public Health, Faculty of Medicine
Zip code
930-0194
Address
SUGITANI 2630, Toyama, Toyama-shi, Japan
TEL
080-8850-0489
Homepage URL
m-nagai@amall.co.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Makie Nagai
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2024 | Year | 01 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060371
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