UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022297 |
|---|---|
| Receipt number | R000025691 |
| Scientific Title | Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan. |
| Date of disclosure of the study information | 2016/05/12 |
| Last modified on | 2021/09/08 11:10:57 |
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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
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
muramasa@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025691
