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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012239
Receipt No. R000013570
Scientific Title 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.
Date of disclosure of the study information 2013/11/10
Last modified on 2017/02/20

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Basic information
Public title 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.
Acronym A randomized controlled trial for investigating the efficacy of internet self-learning and filmed social contact for reducing stigma in the university students.
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinsuke Koike
Organization The University of Tokyo
Division name University of Tokyo Institute for Diversity and Adaptation of Human Mind (UTIDAHM)
Zip code
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
1st name
Middle name
Last name Shinsuke Koike
Organization The University of Tokyo
Division name University of Tokyo Institute for Diversity and Adaptation of Human Mind (UTIDAHM)
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results 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 Main results already published
Date of protocol fixation
2013 Year 11 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000013570

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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