UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045088 |
|---|---|
| Receipt number | R000051507 |
| Scientific Title | A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia |
| Date of disclosure of the study information | 2021/10/05 |
| Last modified on | 2025/02/08 09:23:50 |
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Basic information
Public title
A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Acronym
A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Scientific Title
A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Scientific Title:Acronym
A Feasibility Study of an Online Cognitive Behavioral Therapy Program for Family Caregivers of people with Dementia
Region
| Japan |
Condition
Condition
Family caregivers of people with dementia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the feasibility of implementing an online cognitive behavioral therapy program for family caregivers of people with dementia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The burden experienced by family caregivers after the end of the intervention(8 weeks)
Key secondary outcomes
1.psychological variable of the family caregivers(HADS, HRQOL, DCPFS-21)
2.Behavioral and Psychological Symptoms of
Dementia(BPSD) in patients with dementia(NPI-Q)
Feasibility assessment
1.Dropout rate
2.Incidence of adverse events
3.Satisfaction with the program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An online CBT program (50 minutes x 8 sessions) will be conducted for family caregivers.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who aged between 20 and 80 years old
2.Those who have relatives with mild cognitive impairment (MCI) or symptoms of dementia.
3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading).
4.Those who can basically attend the program once a week via video conferencing system (WebEx, Zoom, etc.).
Key exclusion criteria
1.Those who have been declared to have a life expectancy of less than one year due to physical illness.
2.Those who are scheduled to be hospitalized for mental or physical illness.
3.Those who are deemed to have difficulty in participating by the researcher due to other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
taji0808@gmail.com
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Tajima |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
taji0808@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Foundation for Total Health Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical and Translational Research Center
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
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
| 2021 | Year | 10 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051507
