UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open-label parallel group randomized controlled trial for investigating the efficacy and persistence of internet self-learning and filmed social contact for reducing stigma in the university students.
Title of the study (Brief title)	A randomized controlled trial for investigating the efficacy of internet self-learning and filmed social contact for reducing stigma in the university students.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The video lecture which contains not only the knowledge of mental illness but also interviews for people with mental illnesses (Social Contact [SC] Group) would be superior in reducing stigma to self-instructional internet search (Internet [Int] Group).
Basic objectives2	Others
Basic objectives -Others	Both SC and Int group would be superior to control (Con) group in reducing stigma.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Future domain of Reported and Intended Behaviour Scale - Japanese language version (RIBS-J) at 12-month survey.
Key secondary outcomes	Future domain of RIBS-J at post-intervention and 1-month surveys, and the Japanese-language version of Social Distance Scale (SDSJ), the Mental Illness and Disorder Understanding Scale (MIDUS), and English National Survey at post-intervention, 1-month, and 12-month surveys.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Thirty-minute video lecture which contains not only the knowledge of mental illness but also interviews for people with mental illnesses (Social Contact [SC] Group).
Interventions/Control_2	Thirty-minute self-instructional internet search (Internet [Int] Group).
Interventions/Control_3	Thirty-minute playing games irrespective of mental health (Control [Con] Group).
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	25 years-old >=
Gender	Male and Female
Key inclusion criteria	The students recruited from the job recruitment cite at several universities and colleges in Tokyo.
Key exclusion criteria	The students who will not be university or college students one year later, the students who will not live in Japan one year later, and 3 grades or more students in the department of medicine or psychology at registration.
Target sample size	240

Research contact person
Name of lead principal investigator	Shinsuke Koike
Organization	The University of Tokyo
Division name	University of Tokyo Institute for Diversity and Adaptation of Human Mind (UTIDAHM)
Address	3-8-1, Komaba, Meguro-ku, Tokyo 153-8902, JAPAN
TEL	+81354544327
Email	skoike-tky@umin.ac.jp

Public contact
Name of contact person	Shinsuke Koike
Organization	The University of Tokyo
Division name	University of Tokyo Institute for Diversity and Adaptation of Human Mind (UTIDAHM)
Address	3-8-1, Komaba, Meguro-ku, Tokyo 153-8902, JAPAN
TEL	+81354544327
Homepage URL
Email	skoike-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Grant from the JSPS/MEXT (No. 25870143 and T26118703)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Takeda Science Foundation and Uehiro Foundation on Ethics and Education
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	東京大学（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 11 Month 09 Day
Anticipated trial start date	2013 Year 11 Month 11 Day
Last follow-up date	2015 Year 09 Month 30 Day
Date of closure to data entry	2015 Year 10 Month 10 Day
Date trial data considered complete	2015 Year 10 Month 10 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 07 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013570