UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060315 |
|---|---|
| Receipt number | R000068980 |
| Scientific Title | The Effects of Trauma-Informed Care Training for Psychiatric Nurses in Ukraine |
| Date of disclosure of the study information | 2026/01/11 |
| Last modified on | 2026/01/10 11:08:37 |
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Basic information
Public title
The Effects of Trauma-Informed Care Training for Psychiatric Nurses in Ukraine
Acronym
The Effects of Trauma-Informed Care Training for Psychiatric Nurses in Ukraine (TIC-Psychiatric Nurses Ukraine)
Scientific Title
The Effects of Trauma-Informed Care Training for Psychiatric Nurses in Ukraine
Scientific Title:Acronym
The Effects of Trauma-Informed Care Training for Psychiatric Nurses in Ukraine
Region
| Europe |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a developed face-to-face Trauma-Informed Care training for psychiatric nurses in Ukraine on their mental health and workplace psychological safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuous traumatic stress responses: The Continuous Traumatic Stress Response Scale (CTSR)
Depressive symptoms: Patient Health Questionnaire-9 (PHQ-9)
Workplace psychological safety: Safety Attitudes Questionnaire-Short Form (SAQ-SF)
Professional quality of life among healthcare workers: Professional Quality of Life Scale-Health Version (ProQOL-health)
Burnout: Questionnaire for Identifying Professional Burnout Syndrome
Evaluation timings: at the first survey (before the intervention), at the second survey (immediately after the intervention), and at the third survey (approximately three months after the intervention).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention consists of attending face-to-face trauma-informed care training.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Psychiatric nurses working at a specialized psychiatric healthcare institution in Ukraine who provided informed consent to participate in the study.
Key exclusion criteria
N/A
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Doi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
doi-saki611@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo, Department of Mental Health
Institute
Department
Personal name
Funding Source
Organization
Departmental operating and research funds of the Department of Mental Health, Graduate School of Medicine, The University of Tokyo; and a grant from the Japan International Cooperation Agency
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
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 01 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068980
