UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033272 |
|---|---|
| Receipt number | R000037211 |
| Scientific Title | A pilot randomized controlled trial of videoconference-based or in-person cognitive behavioral therapy for family caregivers of people with dementia. |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2018/07/04 13:30:18 |
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Basic information
Public title
A pilot randomized controlled trial of videoconference-based or in-person cognitive behavioral therapy for family caregivers of people with dementia.
Acronym
A pilot RCT of CBT for family caregivers of people with dementia.
Scientific Title
A pilot randomized controlled trial of videoconference-based or in-person cognitive behavioral therapy for family caregivers of people with dementia.
Scientific Title:Acronym
A pilot RCT of CBT for family caregivers of people with dementia.
Region
| Japan |
Condition
Condition
Family caregiving of people with Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to examine the effectiveness for behavioral and psychological of symptoms with dementia (BPSD) when family caregivers of people with dementia receive cognitive behavioral therapy (CBT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuropsychiatric Index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy
Interventions/Control_2
treatment as usual
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)Patient with a diagnosis of dementia or mild cognitive impairment (MCI) in DSM-5, and having behavior and psychological symptoms of dementia.
2)Patient with dementia is living together with at least one family caregiver.
Key exclusion criteria
1)Participants with severe dementia, psychosis, bipolar disorders and substance abuse or dependence.
2)Participants with current high risk of suicide.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Graduate School of Medicine Chiba University,Chiba University Hospital
Division name
Research Center for Child Mental Development,Department of Cognitive Behavioral physiology,Cognitive behaviora Therapy Center
Zip code
Address
1-8-1 Inohana,Chuouku,Chiba,Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kagawa |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Cognitive Behavioral physiology
Zip code
Address
1-8-1 Inohana,Chuouku,Chiba,Japan
TEL
043-226-2027
Homepage URL
ahwa4436@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Sodegaura Satsukidai Hospital
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
| 2018 | Year | 07 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 05 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037211
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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