UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049349 |
|---|---|
| Receipt number | R000056203 |
| Scientific Title | Impact of the COVID-19 Pandemic on Psychiatric Health Care Workers |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2024/03/23 12:55:11 |
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Basic information
Public title
Impact of the COVID-19 Pandemic on Psychiatric Health Care Workers
Acronym
Impact of the COVID-19 Pandemic on Psychiatric Health Care Workers
Scientific Title
Impact of the COVID-19 Pandemic on Psychiatric Health Care Workers
Scientific Title:Acronym
Impact of the COVID-19 Pandemic on Psychiatric Health Care Workers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are:
1. To determine the individual and societal impact of a coronavirus pandemic on a broad sample of psychiatry workers. 2. To identify impact patterns and profiles with respect to sociodemographic and occupational characteristics.
3. To examine the professional and personal impact on psychiatric providers and its association with pre-COVID-19 stressors and current mental health difficulties, secondary traumatic stress, burnout, resilience, emotional satisfaction, and social support.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between the impact of the COVID-19 pandemic and mental health problems (anxiety, depression, PTSD symptoms) experienced by individual respondents
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years-old and older
Key exclusion criteria
N/A
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Misari |
| Middle name | |
| Last name | Oe |
Organization
Kurume University
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
Asahi-machi 67, Kurume
TEL
0942317564
oe_misari@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Misari |
| Middle name | |
| Last name | Oe |
Organization
Kurume University
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
Asahi-machi 67, Kurume
TEL
0942317564
Homepage URL
oe_misari@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume 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
Kurume University
Address
Asahi-machi 67, Kurume
Tel
0942317564
oe_misari@kurume-u.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
| 2022 | Year | 12 | Month | 01 | 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
1000
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056203
