UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049373 |
|---|---|
| Receipt number | R000056228 |
| Scientific Title | Effect of Psychological Support Program to Protect the Morals of Suicide Prevention Supporters |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/07/11 13:56:21 |
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Basic information
Public title
Effect of Psychological Support Program to Protect the Morals of Suicide Prevention Supporters
Acronym
Effect of Psychological Support Program to Protect the Morals of Suicide Prevention Supporters
Scientific Title
Effect of Psychological Support Program to Protect the Morals of Suicide Prevention Supporters
Scientific Title:Acronym
Effect of Psychological Support Program to Protect the Morals of Suicide Prevention Supporters
Region
| Japan |
Condition
Condition
Moral Injury
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effect of a psychological support program for suicide prevention supporters to learn cognitive modification and coping behaviors to maintain morals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of Rushton Moral Resilience Scale
Maslach Burnout Inventory Scale
Key secondary outcomes
the Kessler Psychological Distress Scale
Resilience Scale(RS-14)
Sense of Coherence Scale(SOC-13 scale)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention Group
1. training
(90 minutes lecture, 90 minutes role play)
2. 3-month waiting period
Interventions/Control_2
Control Group
1. 3-month waiting period
2. training
(90 minutes lecture, 90 minutes role play)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Suicide Prevention Supporters
(Psychiatric healthcare workers, Telephone volunteers, Community health and welfare professionals
Key exclusion criteria
None
Target sample size
100
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 | Masana |
| Middle name | |
| Last name | Ujihara |
Organization
Shukutoku University
Division name
College of Nursing and Nutrition
Zip code
2608703
Address
673 Nitona-cho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051881
Homepage URL
https://tsukuba-medical.netlify.app/
masana.ujihara@soc.shukutoku.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
