UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053002 |
|---|---|
| Receipt number | R000060405 |
| Scientific Title | A Retrospective Survey Study on the Impact of Psychological Traits on Mental Health Changes During the COVID-19 Pandemic |
| Date of disclosure of the study information | 2023/12/05 |
| Last modified on | 2025/06/06 19:44:00 |
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Basic information
Public title
Study of the Impact of Psychological Traits on Mental Health Changes in the COVID-19 Pandemic
Acronym
The Psychological Factors in COVID-19-Related Mental Health Decline
Scientific Title
A Retrospective Survey Study on the Impact of Psychological Traits on Mental Health Changes During the COVID-19 Pandemic
Scientific Title:Acronym
A Retrospective Survey Study on the Impact of Psychological Traits on Mental Health Changes During the COVID-19 Pandemic
Region
| Japan |
Condition
Condition
Depression, Anxiety Disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to investigate the influence of personality traits and stress coping strategies on the exacerbation of depression, anxiety, and feelings of loneliness during the COVID-19 pandemic.
Basic objectives2
Others
Basic objectives -Others
The secondary objectives include comparing and examining the relevance of these factors between individuals whose mental health deteriorated and those who did not deteriorate due to the COVID-19 outbreak.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is to assess the changes in Hospital Anxiety and Depression Scale (HAD) scores and UCLA Loneliness Scale Version 3 Short Form scores during four measurement points: the 'Pre-COVID-19 period (before November 2019),' the 'First COVID-19 state of emergency (April 7 to May 25, 2020),' the 'Post-COVID-19 pandemic period (personally challenging),' and the 'Current status.' Subsequently, assessing the impact of Ten Item Personality Inventory (TIPI-J) factor scores and Brief COPE (Brief COPE) factor scores on these observed changes.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants for Online Surveys Using Crowdsourcing Service (Lancers: https://www.lancers.jp/help/terms).
2. Those Who Can Read the Description of Online Research and Provide Consent to Participate Online.
Key exclusion criteria
1.Those Who Cannot Participate in Online Surveys.
2.Those Who Cannot Read the Research Description and Cannot Agree to Participate in the Study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798544517
hisaono@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798544517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kwansei Gakuin 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
Ethics Committee for Life Science and Medical Research Involving Human Subjects
Address
Gakuen Uegahara 1 ban Sanda, Hyogo
Tel
0795659052
med-ethic@kwansei.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
| 2023 | Year | 12 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Online survey using crowdsourcing service
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060405
