UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An attempt to incorporate Strategic Sharing into the SST (Social skills training)program conducted in psychiatric daycare section
Title of the study (Brief title)	An attempt to incorporate Strategic Sharing into the SST
Region	Japan

Condition
Condition	Mental illness
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Emiko Asada
Organization	Kyoto University Hospital
Division name	Day Care Unit
Address	54 Shogoin-Kawaharacho,Sakyo-ku, Kyoto
TEL	075-751-3393
Email	asadaemk@kuhpo.kyoto-u.ac.jp

Public contact
Name of contact person	Emiko Asada
Organization	Kyoto University Hospital
Division name	Day Care Unit
Address	54 Shogoin-Kawaharacho,Sakyo-ku, Kyoto
TEL	075-751-3393
Homepage URL
Email	asadaemk@kuhpo.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Kyoto University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都大学医学部附属病院(京都府）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2018 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033959