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Recruitment status Terminated
Unique ID issued by UMIN UMIN000018324
Receipt No. R000021201
Scientific Title Research on feasibility of Cognitive Behavioral Therapy for people with mild dementia and the caregivers in Japan
Date of disclosure of the study information 2015/07/15
Last modified on 2016/05/12

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Basic information
Public title Research on feasibility of Cognitive Behavioral Therapy for people with mild dementia and the caregivers in Japan
Acronym Cognitive Behavioral Therapy for people with mild dementia and the caregivers
Scientific Title Research on feasibility of Cognitive Behavioral Therapy for people with mild dementia and the caregivers in Japan
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Masami Kashimura
Organization Nippon Medical School
Division name Department of Medical Psychology
Zip code
Address Kyonancho 1-7-1, Musdashino-shi, Tokyo, Japan
TEL 0422-34-3403
Email muramasa@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Kashimura
Organization Nippon Medical School
Division name Department of Medical Psychology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2014 Year 10 Month 01 Day
Date of IRB
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

Other
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

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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