UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044204 |
|---|---|
| Receipt number | R000050474 |
| Scientific Title | Mental health care for young people using videogames; a pilot study on the development of a new intervention method toward Hikikomori and Futoko |
| Date of disclosure of the study information | 2021/05/13 |
| Last modified on | 2022/04/26 16:04:32 |
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Basic information
Public title
Mental health care for young people using videogames; a pilot study on the development of a new intervention method toward Hikikomori and Futoko
Acronym
Mental health care for young people using videogames; a pilot study on the development of a new intervention method toward Hikikomori and Futoko
Scientific Title
Mental health care for young people using videogames; a pilot study on the development of a new intervention method toward Hikikomori and Futoko
Scientific Title:Acronym
Mental health care for young people using videogames; a pilot study on the development of a new intervention method toward Hikikomori and Futoko
Region
| Japan |
Condition
Condition
Social withdrawal , Hikikomori ,school refusal
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to evaluate the effectiveness of an approach using fictional narratives, developed ad hoc ,on improving the empathy and the profile of mood states of Hikikomori and Futoko patients , as a primary endpoint. We set as secondary endpoint an improving in general mental health, relaxation and self esteem .We want to evaluate the overall efficacy on mental health and sociality of an exploratory program based on the use of fictional narratives based on the concept of cinema therapy . Due to the exploratory nature of the trial and the lack of previous researches we decided to set a variety of different outcomes .
We will explore if there is any difference on the dependent variables based on the use of animated video-game(emotional persuasion )versus text reading ( cognitive presuasion )of fictional narratives,secondarily.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will evaluate if the is any statistically significant difference in any value of psychological assessment scales before and right after the ending of the interventional program. The following scales will be used for the primary outcomes:
1) transport narrative questionnaire instrument
2) Abbreviated POMS Questionnaire
3) Multidimentional Empathy Scale (MES)
Key secondary outcomes
We will evaluate if the is any statistically significant difference in any value of psychological assessment scales before and right after the ending of the interventional program. The following scales will be used for secondary outcomes:
1) Questionnaire Rosenberg Self Esteem Scale
2) Relaxation rating scale
3) GHQ The General Health questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention
A group will gain access to an online page developed for this research and will play an original video-game developed using the emotional transportation and narrative persuasion theory . In the original game used in this research the characters go though hardships and discover themselves able to overcome them . This kind of storytelling is believed to perform emotional persuasion on the spectator / player. The game duration will be around 6 hours . The participant can play the game from their own device during the research period.
Psychological assessment tests will be accessible on the research web page, immediately before the programs starts and one week after the end of the program.
Interventions/Control_2
Control
A group will gain access to an online page developed for this research and will read 5 documents based on psychological education program developed by Japanese Ministry of Health, Labour and Welfare.
Psychological assessment tests will be accessible on the research web page, immediately before the programs starts and one week after the end of the program.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients who admit to suffer or had suffer from social withdrawal or Futoko. (auto-declaration)
2) Patients 20 years of age or older (regardless of their gender)
Key exclusion criteria
1) patients who can't self declare any experience of social withdrawal or Futoko.
2) Patients under 20 years of age (regardless of their gender)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tamaki |
| Middle name | |
| Last name | Saito |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
TEL
029-853-3099
tamaki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Francesco |
| Middle name | |
| Last name | Panto |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences, Major in Clinical Sciences
Zip code
305-8577
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
TEL
029-853-3099
Homepage URL
s1630453@u.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1,Tennodai,Tsukuba City ,Ibaraki Prefecture, JAPAN
Tel
029-853-3099
s1630453@u.tsukuba.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
| 2021 | Year | 05 | Month | 13 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050474
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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