UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057009 |
|---|---|
| Receipt number | R000065154 |
| Scientific Title | Assertive case management intervention for preventing reattempt of suicide attempters at psychiatric hospitals in Japan |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/30 22:53:05 |
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Basic information
Public title
Assertive case management intervention for preventing reattempt of suicide attempters at psychiatric hospitals in Japan
Acronym
ACTION-JP study
Scientific Title
Assertive case management intervention for preventing reattempt of suicide attempters at psychiatric hospitals in Japan
Scientific Title:Acronym
ACTION-JP study
Region
| Japan |
Condition
Condition
suicide attempts
Classification by specialty
| Psychiatry | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The ACTION-JP aims to evaluate the feasibility of implementing the assertive case management intervention program developed by the ACTION-J study in psychiatric hospitals and to assess its effectiveness of preventing suicide reattempts among individuals admitted to psychiatric hospitals due to a suicide attempt in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) scores from time of registration to six months after registration.
Key secondary outcomes
1) Incidence rate (person-years) and proportion of deaths (suicides and any cause), first recurrent suicide attempts/self-injury and frequency of suicide attempts/self-injury
2) Proportion of treatment adherence
3) Difference in C-SSRS scores from baseline
4) Difference in BDI-II scores from baseline
5) Difference in GAF scores from baseline
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Assertive case management
Usual clinical practice
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
1) Individuals over 18 years old.
2) Individuals diagnosed with a psychiatric disorder classified into DSM-IV axis I.
3) Individuals who had suicidal intentions confirmed using the Columbia-Suicide Severity Rating Scale.
4) Individuals who can attend the case management interview within one month of their suicide attempt.
5) Individuals who can understand the description of the study and provide informed consent.
6) Individuals who can understand Japanese.
7) Individuals who can attend the case management interviews and the psychoeducation program during hospitalization.
8) Individuals who can visit the participating medical facilities regularly for evaluations and case management.
9) Individuals who have not participated in this study in the past.
Key exclusion criteria
1) Individuals who have a diagnosis that is not classified into DSM-IV axis I.
2) Individuals who have been received the assertive case management in the past.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawanishi |
Organization
Sapporo Medical University
Division name
Department of neuropsychiatry
Zip code
060-8543
Address
S1W16, Chuoh-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
chiaki.kawanishi@gmail.com
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Ishibashi |
Organization
Sapporo Medical University
Division name
Department of neuropsychiatry
Zip code
060-8543
Address
S1W16, Chuoh-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
ryutaroishibashi@yahoo.co.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Sapporo Medical University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Suicide Prevention
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Japanese Association for Emergency Psychiatry
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
S1W16, Chuoh-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
rinri@sapmed.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
ときわ病院（北海道）、沼津中央病院（静岡県）、桶狭間病院藤田こころケアセンター（愛知県）、三重県立こころの医療センター（三重県）、岡山県精神科医療センター（岡山県）、玉名病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | 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
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
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065154
