Unique ID issued by UMIN | UMIN000032514 |
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Receipt number | R000037070 |
Scientific Title | Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial |
Date of disclosure of the study information | 2018/05/08 |
Last modified on | 2022/12/21 11:30:32 |
Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial
Group CBT for dementia family caregivers
Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial
Group CBT for dementia family caregivers
Japan |
Family Caregivers of Dementia
Neurology | Psychosomatic Internal Medicine | Psychiatry |
Adult |
Others
NO
To examine effectiveness of multi-component program based on cognitive behavioral therapy and positive psychology on psychological status, quality of life and caregiver burden of family caregivers of people with dementia.
Efficacy
Hospital Anxiety and Depression Scale: HADS
Japanese version of Zarit Burden Index: J-ZBI-8
EuroQoL-5Dimension-5L: EQ-5D-5L
Japanese version of Caregiving Gratification Scale
Subjective Well-Being Scale
Neuropsychiatric Inventory Questionnaire: NPI-Q
the Japanese version of the Self-Compassionate Reactions Inventory; SCRI-J
Clinical Dementia Rating(CDR) and level of independnce of people with dementia
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as a block.
YES
Central registration
2
Educational,Counseling,Training
Behavior,custom |
Multi-component group intervention based on cognitive behavioral therapy and positive psychology (6 session, every two weeks)
wait-list control
20 | years-old | <= |
Not applicable |
Male and Female
1.Family caregiver of people with dementia
2.Communicable in Japanese
3.Written informed consent
Physical, psychiatric or cognitive disorders that hampers full commitment to the program
128
1st name | Daisuke |
Middle name | |
Last name | Fujisawa |
Keio University School of Medicine
Division of Patient Safety / Department of Neuropsychiatry
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3971
dfujisawa@keio.jp
1st name | Noriko |
Middle name | |
Last name | Tamura |
Keio University School of Medicine
Department of Neuropsychiatry
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3971
tamura.n@keio.jp
Keio University
Japan Agency for Medical Research and Development
Japanese Governmental office
Sakuragaoka Memorial Hospital
National Center of Neurology and Psychiatry
Tokyo Metropolitan Matsuzawa Hospital
Ethical Committee, Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
慶應義塾大学病院(東京都)、桜ヶ丘記念病院(東京都)、国立精神・神経医療研究センター(東京都)、都立松沢病院(東京都)
2018 | Year | 05 | Month | 08 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037070
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/psyg.12919
64
In the whole sample (n = 64), no significant effect was observed on HADS. There was medium effect on role strain (p = 0.04, partial eta2 = 0.08). Positive feelings increased after the intervention but were not maintained at follow-up. In the subgroup analysis of caregivers <65 years, a statistically significant effect was observed for personal strain (p = 0.03, partial eta2 = 0.16). Like the whole sample analysis, positive feelings increased after the intervention but were not maintained at follow-up.
2022 | Year | 12 | Month | 21 | Day |
Participants
Average age: 64.9 years (SD: 12.4)
Male 28.6%, Female 71.4%
No significant difference in social background between the intervention group and the wail-list control group. The QOL was significantly higher in the intervention group.
Care recipients
Average age: 80.6 years (SD: 7.8)
Male 39.1%, Female 60.9%
Alzheimer's dementia: 76.2%
Home care: 90.6%
There was no significant difference in social and clinical background between the groups.
Participants were recruited and received informed consent at other related institutions. Sixty-four people who gave consent were randomized according to age(under 65, over 65) and caregiving status(at home or institutionalized).
The intervention group(n = 32) received six sessions(2 hours each) every 2 weeks. The wail-list control group(n=32) received a 10-week observation period and was invited to join the program after the study period.
No serious adverse event was observed.
Assessments were conducted at three-time points: baseline, 10 weeks, 14 weeks.
Primary outcome: HADS (Hospital Anxiety and Depression Scale)
Secondary outcomes:
J-ZBI-8 (The Japanese version of the Zarit Burden Index-short version)
NPI-Q (Neuropsychiatric Inventory Questionnaire)
EQ-5D-5L (EuroQoL-5Dimension-5L)
DCPFS (Dementia Caregiver Positive Feeling Scale)
SWS (Subjective Well-Being Scale)
SCRI-J (Self Compassion Reaction Inventory)
Completed
2018 | Year | 05 | Month | 08 | Day |
2018 | Year | 05 | Month | 11 | Day |
2018 | Year | 06 | Month | 01 | Day |
2021 | Year | 06 | Month | 05 | Day |
2018 | Year | 05 | Month | 08 | Day |
2022 | Year | 12 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037070
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