UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Creating health for elderly people making full use of regional characteristics
Title of the study (Brief title)	Cognitive Behavioral Stress Management for the Elderly
Region	Japan

Condition
Condition	Psychological distress
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Develop Shogi-assisted cognitive behavioral therapy (S-CBT) program for the elderly and to examine its effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Japanese version of the K6
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	S-CBT was carried out in a group format consisting six about 90-min sessions.
Interventions/Control_2	Waiting list control group were instructed to visit the same place after 6 weeks again to undertake an assessment, who received the same S-CBT program afterwards.
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	60 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	(1)aged over 60 (2) had talented in shogi (3)to provide written informed consent
Key exclusion criteria	Medical morbidity that was not expected to fulfil the test battery of self-rated questionnaires
Target sample size	40

Research contact person
Name of lead principal investigator	Hirokazu Furukawa
Organization	Naruto University of Education
Division name	Graduate School of Education
Address	748, Nakashima, Takashima, Naruto-cho, Naruto-shi, Tokushima-ken, 772-8502 Japan
TEL	0886876317
Email	f-hiro@umin.ac.jp

Public contact
Name of contact person	Hirokazu Furukawa
Organization	Naruto University of Education
Division name	Graduate School of Education
Address	748, Nakashima, Takashima, Naruto-cho, Naruto-shi, Tokushima-ken, 772-8502 Japan
TEL	0886876317
Homepage URL
Email	f-hiro@umin.ac.jp

Sponsor
Institute	Naruto University of Education
Institute
Department

Funding Source
Organization	Grant for Health and Science from the Japan Shogi Association
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

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 09 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	2019 Year 02 Month 25 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041011