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 | 2025/09/19 10:14:53 |
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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, safety, and efficacy of the assertive case management intervention developed by the ACTION-J study for patients admitted to psychiatric hospitals following a suicide attempt.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change from baseline in the total score of the Columbia Suicide Severity Rating Scale (C-SSRS) at the 6-month follow-up.
Key secondary outcomes
1.Incidence of key events, including all-cause mortality, suicide, first recurrent suicide attempt, and self-harm. These will be reported as proportions and person-year rates.
2.Frequency of suicide attempts and self-harm.
3.Continuity of psychiatric care.
4.Change from baseline in C-SSRS scores at each follow-up point.
5.Change from baseline in BDI-II scores.
6.Change from baseline in GAF Scale scores.
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(psychoeducation program and scheduled assertive case management follow-up)
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) Aged 18 years or older.
2) Diagnosed with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) Axis I psychiatric disorder based on clinical evaluation.
3) Confirmed suicidal intent at the time of the index suicide attempt, as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).
4) Enrollment in the study within one month of the index suicide attempt.
5) Ability to understand the study procedures and provide written informed consent.
6) Ability to understand and communicate in Japanese.
7) Ability to participate in scheduled intervention sessions (psychoeducation and assertive case management) during hospitalization.
8) Ability to attend scheduled follow-up visits at participating facilities for evaluations and assertive case management sessions.
9) No prior participation in the current study.
Key exclusion criteria
1) Absence of a DSM-IV Axis I psychiatric diagnosis.
2) Have a history of previous exposure to an assertive case management intervention program of ACTION-J study or the current study.
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
Open public recruiting
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 | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065154
