UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Crisis management, Anti-stigma and Mental-health-literacy Program for University Students (CAMPUS): a controlled before-after study
Title of the study (Brief title)	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	Hirokazu Tachikawa
Organization	University of Tsukuba
Division name	Department of Psychiatry, Faculty of Medicine
Address	Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba
TEL	029-853-3343
Email	tachikawa@md.tsukuba.ac.jp

Public contact
Name of contact person	Asumi Takahashi
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences Majors of Medical Sciences
Address	Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba
TEL	029-853-3343
Homepage URL
Email	s1730441@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 04 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031845