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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name