UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050474