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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044204
Receipt No. R000050474
Scientific Title Development of an interventional approach using video-gaming for Hikikomori and Futoko patients
Date of disclosure of the study information 2021/05/13
Last modified on 2021/05/13

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Basic information
Public title Development of an interventional approach using video-gaming for Hikikomori and Futoko patients
Acronym Development of an interventional approach using video-gaming for Hikikomori and Futoko patients
Scientific Title Development of an interventional approach using video-gaming for Hikikomori and Futoko patients
Scientific Title:Acronym Development of an interventional approach using video-gaming for Hikikomori and Futoko patients
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
Email 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
Email s1630453@u.tsukuba.ac.jp

Sponsor
Institute Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 19 Day
Date of IRB
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
2021 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050474

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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