UMIN-CTR Clinical Trial

Basic information
Public title	Development of an interventional composed approach with animation and dialogue for Hikikomori patients
Acronym	Development of an interventional composed approach with animation and dialogue for Hikikomori patients
Scientific Title	Development of an interventional composed approach with animation and dialogue for Hikikomori patients
Scientific Title:Acronym	Development of an interventional composed approach with animation and dialogue for Hikikomori 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 a combined approach using fictional narratives and dialogue on improving the profile of mood states, ,empathy of Hikikomori 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 and a constructed dialogue based on narrative therapy and 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 animation versus text reading of fictional narratives,secondarily. Further we want to know the relative efficacy of watching ,reading fictional narratives and dialogue on the selected outcomes.
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	Single blind -participants are blinded
Control	Active
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	Narrative club program A A group receiving animation movie watching session and dialogue session . Firstly an animated movie in which characters go though hardships and discover themselves able to overcome them will be used. The movie duration will be around 140 minutes. Structured dialogue The structured dialogue implemented in this research will be a method based on 1) Powell s therapeutic discussion 2) Bandura social learning theory 1971 ( observational learning and vicarious experience ) 3) Narrative therapy ( White and Epston, 1990) 4) Cinema therapy ( Gary Solomon). Taking advantage of the emotional transportation toward the characters of the story we will conduct a structured dialogue to enhance empathy , self efficacy and motivation for treatment of the patients using dialogue techniques . The animation movie and the dialogue program will be around 120 minutes per week, once a week. The duration of the program is about 3 weeks. Psychological assessment tests will be distributed immediately before the programs starts(before the first session) and just after the end of the third session. Workshop sheets will be distributed and collected after each session of the program. Homework sheets will be distributed after each session of the program ( not collected).
Interventions/Control_2	Narrative club program B A group receiving fictional narratives reading session and dialogue session . Firstly an extract of a fictional narrative novel in which characters go though hardships and discover themselves able to overcome them will be used. Structured dialogue The structured dialogue implemented in this research will be a method based on 1) Powell s therapeutic discussion 2) Bandura social learning theory 1971 ( observational learning and vicarious experience ) 3) Narrative therapy ( White and Epston, 1990) 4) Cinema therapy ( Gary Solomon). Taking advantage of the emotional transportation toward the characters of the story we will conduct a structured dialogue to enhance empathy , self efficacy and motivation for treatment of the patients using dialogue techniques . The fictional narrative reading session and the dialogue program will be around 120 minutes per week, once a week. The duration of the program is about 3 weeks. Psychological assessment tests will be distributed immediately before the programs starts(before the first session) and just after the end of the third session. Workshop sheets will be distributed and collected after each session of the program. Homework sheets will be distributed after each session of the program ( not collected).
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	18 years-old <
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Stable mental condition 2) Patients who received the permission by the attending physician 3) patients diagnosed with social withdrawal by a psychiatrist 4) Patients who had persisted social withdrawal symptoms for over 6 months 5) Patients 18 years of age or older (regardless of their gender)
Key exclusion criteria	1) patients who have problems attend a multi-session program due to serious illness 2) patients who permission by their attending physician cant not be confirmed 3) Patients who may show difficulties attending the program due to acute psychosis and other mental disorders
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tamaki Saito
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code
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 Middle name Last name Francesco Panto
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences, Major in Clinical Sciences
Zip code
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
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IRB Contact (For public release)
Organization
Address
Tel
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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	2018 Year 10 Month 24 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	Suspended
Date of protocol fixation	2018 Year 10 Month 17 Day
Date of IRB	2018 Year 12 Month 01 Day
Anticipated trial start date	2019 Year 01 Month 15 Day
Last follow-up date	2019 Year 01 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	2018 Year 10 Month 24 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=R000039457