UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012239 |
|---|---|
| Receipt number | 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 09:49:23 |
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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
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
skoike-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013570
| 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 |
