UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044681 |
|---|---|
| Receipt number | R000051028 |
| Scientific Title | A study of procrastination in patients with circadian rhythm sleep-wake disorders and its association with comorbid psychiatric disorders |
| Date of disclosure of the study information | 2021/06/29 |
| Last modified on | 2025/07/08 11:56:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of procrastination in patients with circadian rhythm sleep-wake disorders and its association with comorbid psychiatric disorders
Acronym
A study of procrastination in circadian rhythm sleep-wake disorders
Scientific Title
A study of procrastination in patients with circadian rhythm sleep-wake disorders and its association with comorbid psychiatric disorders
Scientific Title:Acronym
A study of procrastination in circadian rhythm sleep-wake disorders
Region
| Japan |
Condition
Condition
circadian rhythm sleep-wake disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether procrastination is more prominent in patients with CRSWDs than healthy subjects and whether its extent is associated with the comorbidity of psychiatric disorders including developmental disorders or depression
Basic objectives2
Others
Basic objectives -Others
Behavioral characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the score of the General Procrastination Scale between CRSWD and healthy subjects
Key secondary outcomes
The associations between the score of the General Procrastination Scale and the presence of psychiatric disorders and their extents, and those with relevant measures including BDI, MEQ, ESS, sleep diary and actigraphic parameters
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with DSWPD or N24SWD according to ICSD-3 who visited Fujita Health University Hospital, Department of Psychiatry. Those who have comorbid mood disorders or developmental disorders, who have any ongoing treatments, and who are in remission are allowed.
2) Healthy subjects who match in age
*As healthy subjects, the data from another study (Research on the statistical structure of rest-activity in patients with circadian rhythm sleep-wake disorder) will be used retrospectively.
Key exclusion criteria
In case the researchers judge as inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | NAKAO |
| Middle name | |
| Last name | IWATA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
Homepage URL
tsuyoshi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Fujita He alth University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
Tel
0562-93-2865
r-irb@fujita-hu.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
| 2021 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/07420528.2025.2456563
Number of participants that the trial has enrolled
30
Results
The general procrastination scale (GPS) was not statistically different between patients with circadian rhythm sleep-wake disorders with phase delay and healthy controls. GPS was significantly higher with lower Morningness-Eveningness Questionnaire in the healthy group, whereas the opposite tendency was observed in the patient group. Higher autism spectrum quotient, Adult ADHD Self-Report Scale, and Beck Depression Inventory tended to be associated with higher GPS in the patient group.
Results date posted
| 2022 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 24 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | 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
Measurements include GPS, BDI, MEQ, ESS, (MINI, ASRS, AQ-J for patients only) sleep diary and actigraphy (1-2 week) are implemented at any one point.
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051028
