UMIN-CTR Clinical Trial

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

Social withdrawal , Hikikomori ,school refusal

Classification by specialty

Psychosomatic Internal Medicine

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Faculty of Medicine, University of Tsukuba

Institute

Department

Personal name

Organization

Faculty of Medicine, University of Tsukuba

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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