UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061669 |
|---|---|
| Receipt number | R000070562 |
| Scientific Title | Evaluating the effects of compassion and mindfulness meditation on family caregivers of people with dementia (single-arm pilot study) |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/23 14:04:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluating the effects of compassion and mindfulness meditation on family caregivers of people with dementia (single-arm pilot study)
Acronym
CBI for family caregivers of PWD
Scientific Title
Evaluating the effects of compassion and mindfulness meditation on family caregivers of people with dementia (single-arm pilot study)
Scientific Title:Acronym
Single-arm study of CBI for family caregivers of PWD
Region
| Japan |
Condition
Condition
Family caregivers of patients with dementia
Classification by specialty
| Psychiatry | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of an internet-based compassion and mindfulness meditation program for adult family caregivers of people with dementia, specifically examining improvements in well-being (primary outcome: QoL), emotional regulation (primary outcomes: Four Immeasurables, self-compassion, and mindfulness), and reductions in psychological distress (secondary outcomes: caregiver burden and depression).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total score of the C-DEMQOL [Time Frame: pre, week 3, week 6, week 9, post, 3-month follow-up, and 6-month follow-up]
Key secondary outcomes
1) The total score of the ZBI [Time Frame: pre, week 3, week 6, week 9, post, 3-month follow-up, and 6-month follow-up]
2) The total score of the SOFI-J [Time Frame: pre, week 3, week 6, week 9, post, 3-month follow-up, and 6-month follow-up]
3) The total score of the SOFI-C [Time Frame: pre, week 3, week 6, week 9, post, 3-month follow-up, and 6-month follow-up]
4) The total score of the SCS [Time Frame: pre, post, 3-month follow-up, and 6-month follow-up]
5) The total score of the FFMQ [Time Frame: pre, post, 3-month follow-up, and 6-month follow-up]
6) The total score of the QIDS-SR [Time Frame: pre, week 3, week 6, week 9, post, 3-month follow-up, and 6-month follow-up]
7) The total score of the DASC-21 [Time Frame: pre, post]
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
| Other |
Interventions/Control_1
A 12-week loving-kindness meditation and mindfulness program (weekly 90-minute group sessions and daily homework)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1). Adults aged 18 to 75 years at the time of informed consent
2). Native Japanese speaker
3). Have a family member (including in-laws and aunts and uncles) who has been diagnosed with dementia, and spend more time than anyone else in the family caring for that person
4). The care recipient has been assessed as requiring support or long-term care
5). The care recipient has a DASC-21 score of 31 or higher as measured by the DASC-21
6). Able to use the internet, participate continuously in the 12-week sessions, and complete homework
Key exclusion criteria
A) Experienced instruction in meditation from an expert
B) Suicidal ideation is present (assessed by clinical interview)
C) Symptoms of schizophrenia, bipolar disorder, or alcohol/drug dependence are present
D) Severe physical disorders or cognitive disorders
E) Receiving medication or other psychotherapy for a mental illness
F) The care recipient resides in a specialized facility, such as a special nursing home for the elderly (excluding day care services)
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Science
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
080-1361-9039
caslstudies@gmail.com
Public contact
Name of contact person
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Sciences
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
080-1361-9039
Homepage URL
caslstudies@gmail.com
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kwansei Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University
Address
2-1, Gakuen, Sanda, Hyogo, Japan, 669-1337
Tel
079-565-9052
med-ethic@kwansei.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 23 | Day |
Last modified on
| 2026 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070562
