UMIN-CTR Clinical Trial

Basic information
Public title	Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.
Acronym	Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.
Scientific Title	Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.
Scientific Title:Acronym	Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.
Region	Japan

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

Objectives
Narrative objectives1	To examine feasibility and safety of Cognitive Behavioral Therapy for people with mild cognitive impairment and mild dementia, and the family-caregiver in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	For patients (Pre-assessment-2 to 0 week, Post-assessment 10 to 21 weeks, and after 6 months) 1. Hospital Anxiety and Depression Scale: The sub-scale "anxiety" only (HADS-A) 2. Geriatric Depression Scale (GDS-15) For family-caregiver (Pre-assessment-2 to 0 week, Post-assessment 10 to 21 weeks, and after 6 months) 1. Patient Health Questionnaire-9 (PHQ-9) 2. Zarit caregiver Burden Interview-short version (J-ZBI_8)
Key secondary outcomes	For patient (Pre-assessment-2 to 0 week, Post-assessment 10 to 21 weeks, and after 6 months) 1. Mini International Neuropsychiatric Interview (MINI) 2. Mini Mental State Examination (MMSE) 3. Client Satisfaction Questionnaire (CSQ-8J) 4. Neuropsychiatric Inventory Brief Form (NPI-Q) 5. The ratio of dropout and adverse events 6. Quality of Life-Alzheimer's disease scale 7. Patient Health Questionnaire-9 8. Zarit caregiver Burden Interview-short version 9. The modified Conflict Tactics Scale (mCTS) 10. Hospital Anxiety and Depression Scale (HADS-A) 11. ADL-BI For family-caregiver (Pre-assessment-2 to 0 week, Post-assessment 10 to 21 weeks, and after 6 months) 1. Mini International Neuropsychiatric Interview 2. Neuropsychiatric Inventory Brief Form (NPI-Q) 3. Ratio of dropout and adverse events 4. Hospital Anxiety and Depression Scale (HADS-A) 5. K6 6. Short Form 8 (SF8) 7. The modified Conflict Tactics Scale 8. ADL Barthel Index 9. Free description of participating the program

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	Behavior,custom
Interventions/Control_1	Cognitive Behavioral Therapy 1 for people with MCI or mild dementia. Eight sessions, once a week or biweekly. Intervention duration from 8 to 16 weeks. 30 to 40 minute session Cognitive Behavioral Therapy 2 for family caregivers with relatives with MCI or mild dementia. Eight sessions, once a week or biweekly. Intervention duration from 8 to 16 weeks. 60 to 90 minute session.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	CBT for patients 1. Patients diagnosed as mild dementia or mild cognitive impairment, and over 20 points of MMSE. 2. Patients who live within visiting distance of the hospital. 3. Patients who can spend 15 minutes a day to do the homework assignment. 4. Patients can participate more than two-thirds of the intervention. 5. Native Japanese speaker. CBT for family-caregiver (START; STrAtegies for RelaTives) 1. Now caring for their relatives with MCI or mild dementia and spending time together over 3 days per a week and over 10 hours per a week. 2. Over 20 years old men and women. 3. Experiencing care burden and complaining physical or mental symptoms. 4. Participants can participate more than two-thirds of the intervention. 5. Participants who can spend 30 minutes a day to do the homework assignment. 6. Native Japanese speaker.
Key exclusion criteria	CBT for patient 1. Less than 19 points of HDS-R and MMSE. 2. Patients who cannot continue the intervention due to concurrent psychiatric disorders (ex. schizophrenia, bipolar disorder, alcohol / drug related disorder, A cluster personality disorder, etc.) 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 CBT sessions. 5. Physical disease that may interfere psychological treatment. 6. Patients who have already received CBT or currently receive it. 7. Patients who are judged by the principal investigator due to other reasons, such as difficulty in understanding the procedure of the study or intervention protocol due to illiteracy or intellectual problem, and etc. CBT for family-caregiver 1. With a history of any physical diseases that may interfere psychological treatment and any psychiatric disorders, such as . schizophrenia, bipolar disorder, alcohol / drug related disorder, A cluster personality disorder, etc. 2. People who are given one month to live due to any severe physical diseases. 3. Expected difficult cases, due to having a full schedule, lack motivation, illiteracy, or severe cognitive disorder. 4. People who having a structured psychological therapy (except for supportive therapy). 5. People who are judged by the principal investigator due to other reasons, such as in pregnancy, difficulty in understanding the procedure of the study or intervention protocol due to illiteracy or intellectual problem, and etc.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masami Middle name Last name Kashimura
Organization	Nippon Medical School
Division name	Department of Medical Psychology
Zip code	1800023
Address	Kyonan-cho 1-7-1, Musashino-shi, Tokyo, Japan.
TEL	0422-34-3403
Email	muramasa@nms.ac.jp

Public contact
Name of contact person	1st name Masami Middle name Last name Kashimura
Organization	Nippon Medical School
Division name	Department of Medical Psychology
Zip code	1800023
Address	Kyonan-cho 1-7-1, Musashino-shi, Tokyo, Japan.
TEL	0422-34-3403
Homepage URL
Email	muramasa@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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	Japan

Other related organizations
Co-sponsor	Musashi-Kosugi Hospital Dementia Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Hospital Ethical Committee
Address	Sendagi 1-1-5, Bunkyo-ku, Tokyo
Tel	0338222131
Email	inq-ccr@nms.ac.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	日本医科大学付属病院（東京都）、武蔵小杉病院認知症センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 12 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	Terminated
Date of protocol fixation	2016 Year 05 Month 01 Day
Date of IRB	2020 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 12 Day
Last modified on	2021 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025691