UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058697 |
|---|---|
| Receipt number | R000067057 |
| Scientific Title | Factors Associated with the Chronicity of Insomnia in Community-Dwelling Patients with Mental Illness |
| Date of disclosure of the study information | 2025/08/06 |
| Last modified on | 2025/07/31 20:01:10 |
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Basic information
Public title
Factors Associated with the Chronicity of Insomnia in Community-Dwelling Patients with Mental Illness
Acronym
Factors Associated with the Chronicity of Insomnia in Community-Dwelling Patients with Mental Illness
Scientific Title
Factors Associated with the Chronicity of Insomnia in Community-Dwelling Patients with Mental Illness
Scientific Title:Acronym
Factors Associated with the Chronicity of Insomnia in Community-Dwelling Patients with Mental Illness
Region
| Japan |
Condition
Condition
Schizophrenia, Major Depressive Disorder, Bipolar Disorder
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reciprocal relationship between day-to-day cognitive and emotional hyperarousal and insomnia in community-dwelling individuals with mental illness.
Basic objectives2
Others
Basic objectives -Others
To qualitatively clarify the experience of insomnia in daily life, and to examine the reciprocal relationship between cognitive-emotional hyperarousal and insomnia, while considering differences in individual backgrounds.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-sleep mood state, assessed by Brief, Momentary mood Checklist, Japanese Version (BMC-J)
Actigraphy-derived sleep parameters
Key secondary outcomes
Qualitative data regarding the experience of insomnia, obtained from interviews.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Community-dwelling adults aged 20 years or older and under 65 years, with a diagnosis of schizophrenia, major depressive disorder, or bipolar disorder.
2. Individuals who are capable of communication, able to understand the explanation of the study, make an informed decision to participate, and provide written consent.
Key exclusion criteria
1. Individuals who are judged by the facility administrator of the collaborating institution to have insufficient capacity for communication, understanding, or consent due to their psychiatric symptoms or cognitive status.
2. Individuals who are judged by the facility administrator of the collaborating institution to be at risk of their condition worsening as a result of participating in the study.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Umebayashi |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition
Zip code
065-0013
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
TEL
011-741-1051
2024h101@student.tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Umebayashi |
Organization
Tenshi College
Division name
Graduate School of Nursing and Nutrition
Zip code
065-0013
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
TEL
011-741-1051
Homepage URL
2024h101@student.tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Tenshi College
Address
3-1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo
Tel
011-741-1051
soumu@tenshi.ac.jp
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
| 2025 | Year | 08 | Month | 06 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study Design
A one-week, longitudinal, observational study conducted in a daily life setting.
2. Primary Outcome Measures
Daily pre-sleep emotional states (Assessed by: Questionnaire)
Daily sleep patterns (Assessed by: Sleep diary and actigraphy)
3. Sub-study
An interview regarding the experience of insomnia will be conducted with 12 participants who have a score of 6 or higher on the Athens Insomnia Scale (AIS).
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067057
