UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on feasibility of Cognitive Behavioral Therapy for people with mild dementia and the caregivers in Japan
Title of the study (Brief title)	Cognitive Behavioral Therapy for people with mild dementia and the caregivers
Region	Japan

Condition
Condition	dementia, mild cognitive impairment
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine feasibility and safety of Cognitive Behavioral Therapy for people with dementia and the caregivers in Japan
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	For patients 1. Neuropsychiatric Inventory (NPI) 2. Geriatric Depression Scale (GDS15) 3. Hospital Anxiety and Depression Scale, the sub scale "Anxiety" only For caregivers 1. Beck Depression Inventory-2 (in case of older caregivers, GDS15) 2. Zarit caregiver Burden Interview-short version
Key secondary outcomes	For patients 1. K10 2. Clinical Dementia Rating 3. Mini International Neuropsychiatric Interview (MINI) 4. Hasegawa Dementia Scale-Revised 5. Mini Mental State Examination 6. Dropout ratio 7. Adverse events 8. Short Form 8 For caregivers 1. Dementia Behavior Disturbance Scale 2. Crichton Geriatric Behavioral Rating Scale 3. The scale of Valuation of Life

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Cognitive Behavioral Therapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed as dementia with CDR severity from 0.5 to 1.0 (In addition MMSE with its score greater than 20) 2. Patients who live within visiting distance of the hospital 3. Patients who can spend 30 minutes a day to do the homework assignment 4. Native Japanese speaker
Key exclusion criteria	1. Patients who have CDR severity more than 2.0 2. Patients who cannot continue the treatment due to concurrent psychiatric disorders (ex. schizophrenia, bipolar disorder alcohol /drug related disorder, A cluster personality disorder etc.)and severe self-destructive symptoms(self-injury or suicidal attempt, strong psychomotor agitation) 3. Patients who have a history of epilepsy and whose EEG has not been normalized 4. Patients who have too severe cognitive dysfunctions to do CPT sessions 5. Physical disease that may interfere psychological treatment 6. Patients who have already received cognitive behavioral treatment, or currently receive it 7. Patients who cannot come to the hospital regularly(the absence rate of treatment periods > 50%) 8. Patients who are judged by the principal investigator due to other reasons, such as difficulty in understanding the procedure of the study or treatment protocol due to illiteracy or intellectual problem, and etc.
Target sample size	30

Research contact person
Name of lead principal investigator	Masami Kashimura
Organization	Nippon Medical School
Division name	Department of Medical Psychology
Address	Kyonancho 1-7-1, Musdashino-shi, Tokyo, Japan
TEL	0422-34-3403
Email	muramasa@nms.ac.jp

Public contact
Name of contact person	Masami Kashimura
Organization	Nippon Medical School
Division name	Department of Medical Psychology
Address	Kyonancho 1-7-1, Musdashino-shi, Tokyo, Japan
TEL	0422-34-3403
Homepage URL
Email	muramasa@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grants-in-aid for Scientific Research, Ministry of Education, Culture, Sports, Science and Technology- JAPAN
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	日本医科大学武蔵小杉病院（神奈川県） / Nippon Medical School Musashi Kosugi Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 10 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	2015 Year 07 Month 15 Day
Last modified on	2016 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021201