UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027727 |
|---|---|
| Receipt number | R000031380 |
| Scientific Title | A superiority open-label parallel group randomized controlled trial for investigating the efficacy of a biomedical video lecture compared to a video lecture with recommended messages for reducing feasible knowledge toward people with mental health problems |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2023/06/17 12:42:35 |
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Basic information
Public title
A superiority open-label parallel group randomized controlled trial for investigating the efficacy of a biomedical video lecture compared to a video lecture with recommended messages for reducing feasible knowledge toward people with mental health problems
Acronym
A randomized controlled trial for investigating the efficacy of a biomedical video lecture for reducing feasible knowledge toward people with mental health problems
Scientific Title
A superiority open-label parallel group randomized controlled trial for investigating the efficacy of a biomedical video lecture compared to a video lecture with recommended messages for reducing feasible knowledge toward people with mental health problems
Scientific Title:Acronym
A randomized controlled trial for investigating the efficacy of a biomedical video lecture for reducing feasible knowledge toward people with mental health problems
Region
| Japan |
Condition
Condition
General population
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A biomedical video lecture (BMD) would improve more feasible knowledge of stigma toward people with mental health problems compared to a video lecture with recommended messages (RMD) including recovery-oriented, social inclusion/human rights, and high prevalence (Clement et al. EPS 2010).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in feasible knowledge of stigma toward people with mental health problems measured using the Mental Illness and Disorder Understanding Scale(MIDUS) from the baseline to the post intervention
Key secondary outcomes
Change in behavioural intention measured using the Reported and Intended Behaviour Scale (RIBS-J) and help seeking intention toward themselves and people with mental health problems measured using help seeking intention questionnaires (Rusch et al. Psychiatr Serv 2011) from the baseline to the post intervention, and the 1-month and 12-month follow-ups. Change in the MIDUS score from the baseline to the 1-month and 12-month follow-ups was also compared.
We also intend to define 25% or more decrease of RIBS-J score (1SD change from Koike et al. EPS 2016) from the baseline to each follow-up as the increase of stigma, and compare the number of those who have increase of stigma between the groups.
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A 10-min biomedical video lecture (BMD)
Interventions/Control_2
A 10-min video lecture with recommended messages (RMD)
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who were recruited by website recruitment boards.
Key exclusion criteria
Those who are unable to read and write in Japanese equivalent to the graduation of junior high school in Japan.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Koike |
Organization
The University of Tokyo
Division name
Graduate School of Arts and Sciences
Zip code
1538902
Address
3-8-1 Komaba, Meguro-ku, Tokyo
TEL
0354544327
skoike-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Koike |
Organization
The University of Tokyo
Division name
Graduate School of Arts and Sciences
Zip code
1538902
Address
3-8-1 Komaba, Meguro-ku, Tokyo
TEL
0354544327
Homepage URL
skoike-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Department of Arts and Sciences, The University of Tokyo
Address
3-8-1 Komaba, Meguro-ku, Tokyo
Tel
+81-3-5465-7617
ken9.c@gs.mail.u-tokyo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031380
| Research Plan | |
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| 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 |
