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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033272
Receipt No. R000037211
Official scientific title of the study 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

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Basic information
Official scientific title of the study A pilot randomized controlled trial of videoconference-based or in-person cognitive behavioral therapy for family caregivers of people with dementia.
Title of the study (Brief title) 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 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
Address 1-8-1 Inohana,Chuouku,Chiba,Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person Akira Kagawa
Organization Graduate School of Medicine Chiba University
Division name Department of Cognitive Behavioral physiology
Address 1-8-1 Inohana,Chuouku,Chiba,Japan
TEL 043-226-2027
Homepage URL
Email ahwa4436@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037211

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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