UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045879 |
|---|---|
| Receipt number | R000052343 |
| Scientific Title | The effects of trauma-informed care on improving the treatment of psychiatric inpatient |
| Date of disclosure of the study information | 2021/10/31 |
| Last modified on | 2025/06/09 16:22:12 |
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Basic information
Public title
The effects of trauma-informed care on improving the treatment of psychiatric inpatients
Acronym
TIC-RESCOPE
Scientific Title
The effects of trauma-informed care on improving the treatment of psychiatric inpatient
Scientific Title:Acronym
TIC-RESCOPE
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of trauma-informed care training using video for psychiatric nurses and nursing assistants on improving the treatment of inpatients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration and frequency of use of seclusion and mechanical restraint (up to 6 months after intervention)
Key secondary outcomes
For nurses/nursing assistants (pre-intervention, and 3 months after the start of intervention,6 months after the start of intervention)
Japanese Burnout Scale
Kessler Psychological Distress Scale (K6)
Attitude Related trauma-Informed Care Scale 10 (ARTIC-10)
For inpatients
Duration and frequency of use of seclusion and mechanical restraint (up to 12 months after intervention)
Dose of antipsychotics (at admission, at discharge)
Duration of hospitalization
other:
Incident reports
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:.
Within twelve weeks, five trauma-informed care video trainings based on the principles of trauma-informed care will be provided.
Module 1) Description of Trauma-informed Care
Module 2) Description of PTSD Symptoms
Module 3) Case studies in view of trauma-informed care
Module 4) Practice of Trauma-informed care
Module 5) The decrease of seclusion and mechanical restraint base on trauma-informed care
Interventions/Control_2
Control group: TAU
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
Nurses and Nursing assistant working in psychiatric wards
Patients admitted to the target psychiatric hospital between April 2019 and March 2023.
Key exclusion criteria
Patients admitted to forensic ward
Target sample size
40000
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 | Michi |
| Middle name | |
| Last name | Miyake |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Public Mental Health Research
Zip code
1878551
Address
4-1-1, Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
rescope@ncnp.go.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Mental Health, National Center of Neurology and Psychiatry
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
神奈川県立精神医療研究センター（神奈川）,岡山県精神科医療センター（岡山）,長野県立こころの医療センター駒ヶ根（長野）,静岡県立こころの医療センター（静岡）,石川県立高松病院（石川）,草津病院(広島),未来の風せいわ病院（岩手）,曽我病院（神奈川）,鈴鹿厚生病院（三重）,松原病院（福井）,刈谷病院（愛知）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2666142X25000074?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2666142X25000074?via%3Dihub
Number of participants that the trial has enrolled
9880
Results
Using a difference-in-differences analysis, we interpreted the results to indicate that the intervention led to a statistically significant reduction in average restraint time compared with the control group at 3 months (p = 0.04), 6 months (p = 0.01), and 12 months (p = 0.02). However, no statistically significant reduction was observed in the average seclusion time.
Results date posted
| 2025 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were admitted to 10 psychiatric hospitals from April 2020 to October 2021, and from February 2022 to January 2023.
Participant flow
Data were collected through a specialized psychiatric monitoring system called RESCOPE, and hospitals that had implemented this system were invited to participate in the study. Hospitals interested in the trauma-informed care video training were allocated to the intervention group, and the rest were assigned to the control group.
Adverse events
No significant Adverse events
Outcome measures
Average seclusion/restraint time per day, calculated by dividing the total seclusion/restraint time for each episode by the total number of inpatient days.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052343
