UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055779 |
|---|---|
| Receipt number | R000062885 |
| Scientific Title | Observational study to find affecting factors to the follow-up interventions and effective support measures for suicide attempters |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2024/10/08 12:42:01 |
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Basic information
Public title
Observational study to find affecting factors to the follow-up interventions and effective support measures for suicide attempters
Acronym
Observational study to find affecting factors to the follow-up interventions and effective support measures for suicide attempters
Scientific Title
Observational study to find affecting factors to the follow-up interventions and effective support measures for suicide attempters
Scientific Title:Acronym
Observational study to find affecting factors to the follow-up interventions and effective support measures for suicide attempters
Region
| Japan |
Condition
Condition
Suicide attempt
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the factors affecting suicide re-attempts one year after discharge in subjects of follow-up interventions for suicide attempters, and to consider more effective support measures.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the factors affecting suicide re-attempts, and to consider more effective support measures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Patient Background: Attributes (gender, age, occupation), cohabitants, history of psychiatric consultations, history of physical medical consultations, family history, habitual drinking, medication history.
2. History of attempted suicide: Number of suicide attempts, method of attempt, alcohol use at the time of attempt, causes of the attempt, route to consultation.
3. Patient Status: status of case management, subject of case management, status of psychiatric receipt, status of physical receipt, suicidal re-contemplation, self-harm, stressful events, availability of consulting partners, consulting agencies used, coordination of psychiatric receipt, coordination of physical receipt, referral status of consulting agencies and consulting partners.
Key secondary outcomes
MINI, BPRS, Sigh-D(Structured Interview Guide for the Hamilton Depression Rating Scale), SIGMA(MADRS), Columbia-Suicide Severity Rating Scale(C-SSRS), TCI, QIDS-R, TAC-24, Positive Affect Scale, INQ-25, ACSS-20, BISSEN(Brief Inventory of Social Support Exchange Network), JART, Social Readjustment Rating Scale(SRRS), PSS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suicide attempt patients admitted to Ibaraki Prefectural Medical Center of Psychiatry who were eligible for follow-up intervention projects conducted at the center.
Key exclusion criteria
None
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Tachikawa |
Organization
University of Tsukuba
Division name
Department of Disaster and Community Psychiatry, Faculty of Medicine
Zip code
3058575
Address
Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL
029-853-3343
tachikawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Tachikawa |
Organization
University of Tsukuba
Division name
Department of Disaster and Community Psychiatry, Faculty of Medicine
Zip code
3058575
Address
Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL
029-853-3343
Homepage URL
tachikawa@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ibaraki Prefectural Medical Center of Psychiatry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2024 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
548
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
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method of recruitment: patients admitted to t Ibaraki Prefectural Medical Center of Psychiatry between 1 April 2010 and 31 March 2023, who were eligible for the follow-up intervention project conducted at the center.
Management information
Registered date
| 2024 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062885
