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Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.

Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan. - Cognitive Behavioral Therapy for people with mild cognitive impairment, mild dementia and the family-caregiver in Japan.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022297
Enrollment
30
Registered
2016-05-12
Start date
2016-05-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild dementia, and mild cognitive impairment

Interventions

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 Behavior

Sponsors

Nippon Medical School
Lead Sponsor
Musashi-Kosugi Hospital Dementia Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMasami Kashimura

Nippon Medical School Department of Medical Psychology

muramasa@nms.ac.jp0422-34-3403

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026