UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027790 |
|---|---|
| Receipt number | R000031845 |
| Scientific Title | Crisis management, Anti-stigma and Mental-health-literacy Program for University Students (CAMPUS): a controlled before-after study |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2017/12/26 14:26:15 |
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Basic information
Public title
Crisis management, Anti-stigma and Mental-health-literacy Program for University Students (CAMPUS): a controlled before-after study
Acronym
CAMPUS : a controlled before-after study
Scientific Title
Crisis management, Anti-stigma and Mental-health-literacy Program for University Students (CAMPUS): a controlled before-after study
Scientific Title:Acronym
CAMPUS : a controlled before-after study
Region
| Japan |
Condition
Condition
Suicide
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to develop the comprehensive suicide prevention educational program for a university students, which eliminate the self stigma and improve mental health literacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suicide Behaviors Questionnaire-Revised(SBQ-R)
Key secondary outcomes
(1) Quick Inventory of Depressive Symptomatology
(2) Interpersonal Needs Questionnaire Acquired Capability for Suicide Scale
(3) Global Stigma Inventory (Original)
(4) Brief COPE
(5) General Help-Seeking Questionnaire
(6) WHO-5
(7) Gatekeeper self-efficacy scale
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
University students
Key exclusion criteria
SBQ-R>=7 or QIDS-J>=11
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Tachikawa |
Organization
University of Tsukuba
Division name
Department of Psychiatry, Faculty of Medicine
Zip code
Address
Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba
TEL
029-853-3343
tachikawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asumi Takahashi |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences Majors of Medical Sciences
Zip code
Address
Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba
TEL
029-853-3343
Homepage URL
s1730441@u.tsukuba.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
Address
Tel
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
| 2017 | Year | 06 | Month | 30 | 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
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to observe psychological changes of the university students by carrying out the suicide prevention educational program and to evaluate the effect of the program.
This program includes the lecture and role-playing. The lecture is about suicide prevention, stigma and mental health literacy. The role-playing includes the training of the self-disclosure and the listening closely.
Management information
Registered date
| 2017 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031845
| 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 |
