UMIN-CTR Clinical Trial

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