UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055205 |
|---|---|
| Receipt number | R000063084 |
| Scientific Title | Factors influencing the effectiveness of a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/12/08 09:33:44 |
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Basic information
Public title
Factors influencing the effectiveness of a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia
Acronym
Investigation of factors influencing the effectiveness of group multi-component program for caregivers of people with dementia
Scientific Title
Factors influencing the effectiveness of a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia
Scientific Title:Acronym
Factors influencing the effectiveness of a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the characteristics of caregivers that will be benefit from a group multi-componet program based on cognitive behavioral therapy and positive psychology for family caregivers of people with dementia.
Basic objectives2
Others
Basic objectives -Others
Targeting participants in a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia, this study aims to identify the characteristics that will benefit from the program, taking into account factors such as the psychosocial background of family caregivers, the clinical and social background of dementia patients, and the intensity of the program.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chang in depression and anxiety (HADS: Hospital Anxiety Depression Scale) of family caregivers before and after intervention
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Family caregivers of dementia who have previously attended a group multi-component program based on cognitive behavioral therapy and positive psychology for caregivers of people with dementia and agreed to provide data.
Key exclusion criteria
Those who have requested to stop providing information by opting out
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | Takasaki |
| Last name | Tamura |
Organization
Keio University School of Medicine
Division name
Medical Education Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
080-7704-2098
cbt.kaigo.2018@gmail.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | Takasaki |
| Last name | Tamura |
Organization
Keio University School of Medicine
Division name
Medical Education Center
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
080-7704-2098
Homepage URL
cbt.kaigo.2018@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The UNIVERS FOUNDATION
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
| 2024 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/psyg.12919
Number of participants that the trial has enrolled
64
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
Main results already published
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analysis will be conducted using the psychosocial backgrounds, number of class attendances, etc. of participants in a group multi-component program based on cognitive behavioural therapy and positive psychology for family caregivers of people with dementia.
Management information
Registered date
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063084
