UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036003 |
|---|---|
| Receipt number | 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 15:55:37 |
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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
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
f-hiro@umin.ac.jp
Sponsor or person
Institute
Naruto University of Education
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041011
