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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036003
Receipt No. R000041011
Scientific Title Creating health for elderly people making full use of regional characteristics
Date of disclosure of the study information 2019/02/25
Last modified on 2019/02/25

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Basic information
Public title Creating health for elderly people making full use of regional characteristics
Acronym Cognitive Behavioral Stress Management for the Elderly
Scientific Title Creating health for elderly people making full use of regional characteristics
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirokazu Furukawa
Organization Naruto University of Education
Division name Graduate School of Education
Zip code
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
1st name
Middle name
Last name Hirokazu Furukawa
Organization Naruto University of Education
Division name Graduate School of Education
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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