UMIN-CTR Clinical Trial

Basic information
Public title	Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Acronym	Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Scientific Title	Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Scientific Title:Acronym	Development of a CBT program for care burden on family caregivers of people with dementia and study of the feasibility and effectiveness
Region	Japan

Condition
Condition	Family caregivers of people with dementia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the CBT program delivered by visiting nurses on their home nursing visits, using before and after study targeting family caregivers of people with dementia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The burden experienced by family caregivers after the end of the intervention(12 weeks)
Key secondary outcomes	Effectiveness Evaluation 1.care burden on the family caregivers(ZBI-J) 2.psychological variable of the family caregivers(HADS HRQOL, Brief COPE, SWL) 3.Behavioral and Psychological Symptoms of Dementia(BPSD) in patients with dementia(NPI-Q) Feasibility Evaluation 1. Drop out rate 2. Adverse event rate 3. Level of satisfaction with the program(CSQ-8)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Visting nurses deliver the CBT program(30minutes,11 sessions) on their home nursing visits.
Interventions/Control_2
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Those who aged between 20 and 79, inclusive. 2.Those who spend their time with families diagnosed with dementia more than ten hours a week. 3.Those who have no communication problem in Japanese(listening, speaking, writing, or reading). 4.Those who can attend the program once a week basically.
Key exclusion criteria	1.Those who score 23 points or less of MMSE (measured when aged 60 or over). 2.Those who are diagnosed with schizophrenia, substance use disorder, or organic mental disorder. 3.Those who are given less than one year to live due to cancer or other diseases. 4.Those who are deemed to have difficulty in participating by the researcher due to other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Miyuki Middle name Last name Tajima
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL	042-341-2712
Email	mtajima@ncnp.go.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Tajima
Organization	National Center of Neurology and Psychiatry
Division name	National Center for Cognitive Behavior Therapy and Research
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
TEL	042-341-2712
Homepage URL
Email	mtajima@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	intramural research grant for neurological and psychiatric disorders of NCNP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel	042-341-2712
Email	rinri-jimu@ncnp.go.jp

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 03 Month 01 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	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 22 Day
Date of IRB	2017 Year 09 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 27 Day
Last modified on	2020 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035943