UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034618 |
|---|---|
| Receipt number | R000039457 |
| Scientific Title | Development of an interventional composed approach with animation and dialogue for Hikikomori patients |
| Date of disclosure of the study information | 2018/10/24 |
| Last modified on | 2021/05/13 17:15:52 |
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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
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
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039457
