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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032514
Receipt No. 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 2018/08/24

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Basic information
Public title Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial
Acronym Group CBT for dementia family caregivers
Scientific Title Group cognitive behavioral therapy for family caregivers of people with dementia: multi-center randomized control trial
Scientific Title:Acronym Group CBT for dementia family caregivers
Region
Japan

Condition
Condition Family Caregivers of Dementia
Classification by specialty
Neurology Psychosomatic Internal Medicine Psychiatry
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hospital Anxiety and Depression Scale: HADS
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Multi-component group intervention based on cognitive behavioral therapy and positive psychology (6 session, every two weeks)
Interventions/Control_2 wait-list control
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Family caregiver of people with dementia
2.Communicable in Japanese
3.Written informed consent
Key exclusion criteria Physical, psychiatric or cognitive disorders that hampers full commitment to the program
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Fujisawa
Organization Keio University School of Medicine
Division name Division of Patient Safety / Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Email dfujisawa@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Tamura
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Homepage URL
Email tamura.n@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Sakuragaoka Memorial Hospital
National Center of Neurology and Psychiatry
Tokyo Metropolitan Matsuzawa Hospital
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 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)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 08 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
2018 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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
2018 Year 05 Month 08 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037070

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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