UMIN-CTR Clinical Trial

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

dementia, mild cognitive impairment

Classification by specialty

Neurology

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nippon Medical School

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本医科大学武蔵小杉病院（神奈川県） / Nippon Medical School Musashi Kosugi Hospital (Kanagawa)

Date of disclosure of the study information

2015

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

07

Month

15

Day

Last modified on

2016

Year

05

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021201