UMIN-CTR Clinical Trial

Public title

An attempt to incorporate Strategic Sharing into the SST (Social skills training)program conducted in psychiatric daycare section

Acronym

An attempt to incorporate Strategic Sharing into the SST

Scientific Title

An attempt to incorporate Strategic Sharing into the SST (Social skills training)program conducted in psychiatric daycare section

Scientific Title:Acronym

An attempt to incorporate Strategic Sharing into the SST

Region

Japan

Condition

Mental illness

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine how the communicate skills and self-awareness of patients with mental illness changes by learning the Strategic Sharing as a practical technique of SST and practicing it in the SST group.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare the change after intervention between "Strategic Sharing Group" and "normal SST group". For numerical data obtained from the questionnaire, we compare the numbers of both groups, for the language data obtained interview,
SCT (Sentence Completion Technique), and contents of the "Strategic Sharing ", using the GTA (modified version of the Gran Dead theory approach) to extract concepts and to examine the process of change.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Strategic Sharing Enforcement Group
In the SST program as part of the outpatient rehabilitation, to set up "Strategic Sharing" as a practical task among three months.

Interventions/Control_2

Normal SST Enforcement Group
The SST program is conducted as part of outpatient rehabilitation for ten weeks.

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

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

Among the adult outpatients who have been through daycare for psychiatric rehabilitation understand the purpose of this study and wish to participate in the SST program, we chose the persons meet all of the following conditions.
1. The persons over 20 and under 65 years of age (date of consent) 2. A person who speaks the language clearly 3. A person who has obtained the consent of this research participation in the document 4. A person determined to be possible to have the questionnaire inspections required in a specified date after obtaining consent 5. A person determined to be appropriate for this study by the research representative or the research co-worker .

Key exclusion criteria

From the point of view of research purposes, those who fall under any of the following conditions are excluded from this research subject.
1. Those who have not been able to participate in the Those who cannot continue to participate in the program. 2. A person who does not have sufficient consent due to a medical condition 3. A person determined to be inappropriate for this study by the research representative or the research co-worker .

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Emiko Asada

Organization

Kyoto University Hospital

Division name

Day Care Unit

Zip code

Address

54 Shogoin-Kawaharacho,Sakyo-ku, Kyoto

TEL

075-751-3393

Email

asadaemk@kuhpo.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Emiko Asada

Organization

Kyoto University Hospital

Division name

Day Care Unit

Zip code

Address

54 Shogoin-Kawaharacho,Sakyo-ku, Kyoto

TEL

075-751-3393

Homepage URL

Email

asadaemk@kuhpo.kyoto-u.ac.jp

Institute

Kyoto University Hospital

Institute

Department

Personal name

Organization

Kyoto University Hospital

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

京都大学医学部附属病院(京都府）

Date of disclosure of the study information

2017

Year

11

Month

07

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

Preinitiation

Date of protocol fixation

2018

Year

01

Month

15

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

30

Day

Last modified on

2018

Year

01

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033959