UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057698 |
|---|---|
| Receipt number | R000065905 |
| Scientific Title | The Effects of Spiritual Reminiscence on People with Mild Dementia: An Evaluator-Blinded, Randomized Parallel-Group Comparison Study |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2026/10/25 23:37:19 |
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Basic information
Public title
The Effects of Spiritual Reminiscence on People with Mild Dementia
Acronym
Dementia and Spiritual Reminiscence
Scientific Title
The Effects of Spiritual Reminiscence on People with Mild Dementia: An Evaluator-Blinded, Randomized Parallel-Group Comparison Study
Scientific Title:Acronym
SPIREMDEM
Region
| Japan |
Condition
Condition
mild dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reflecting on the meaning and value of life can actively restore existential well-being, including spirituality, and help regain a sense of self-affirmation and self-esteem.
In this study, we aim to investigate whether a certified psychotherapist can more effectively support individuals in recovering their existential well-being (spirituality) through spiritual reminiscence compared to simple reminiscence, which is the primary objective. We also aim to determine whether this approach helps care partners deepen their understanding of the individuals, which is the secondary objective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Functional Assessment of Chronic Illness Therapy Spiritual Well-being 12 Item Scale, version 4
Key secondary outcomes
DEMQOL, DEMQOL-Proxy
Parkinson's Disease Questionnaire-8
Geriatric Depression Scale-15-J
State-Trait Anxiety Inventory
Semi-structured interviews are conducted with care partners. A certified psychologist creates a booklet summarizing the recollections elicited through the intervention. The care partner is asked to read the booklet, and then their impressions of participating in the study and their thoughts on the booklet are elicited through semi-structured interviews.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Spiritual Reminiscence by a certified psychological therapist, 30 minutes per session, six sessions over 6 months.
Interventions/Control_2
Simple Reminiscence by a certified psychological therapist, 30 minutes per session, six sessions over 6 months.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons with mild dementia have an MMSE score of 20/30 or higher.
2. Persons with a care partner (such as a family member, regardless of whether they live together) can participate in the pre- and post-intervention tests and an interview, and accompany them to the hospital.
3. Persons at least 40 years old when obtaining consent (regardless of gender).
4. Outpatients at Kawashima Neurological Clinic who provided written consent of their own free will to participate after receiving sufficient explanation about this study.
5. Persons who do not have significant hearing loss or aphasia can communicate verbally.
Key exclusion criteria
1. Persons with advanced cancer or undergoing chemotherapy.
2. Persons who have changed the dosage of anti-cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine within one month before the pre-intervention examination.
3. Parsons whom the principal investigator deems unsuitable as research subjects.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Kawashima |
Organization
Kawashima Neurology Clinic
Division name
Department of Neurology
Zip code
251-0038
Address
5-13-17, Kugenuma-Matsugaoka, Fujisawa, Kanagawa, Japan
TEL
+81-466-551358
nkawashi@pf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kawashima |
Organization
Kawashima Neurology Clinic
Division name
Department of Neurology
Zip code
251-0038
Address
5-13-17, Kugenuma-Matsugaoka, Fujisawa, Kanagawa, Japan
TEL
+81-466-551358
Homepage URL
nkawashi@pf7.so-net.ne.jp
Sponsor or person
Institute
Kawashima Neurology Clinic
Institute
Department
Personal name
Noriko Kawashima
Funding Source
Organization
Kawashima Neurology Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NO
Name of secondary funder(s)
NO
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
+81-3-3263-4801
mirai-ec1@mirai-iryo.com
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
かわしま神経内科クリニック（神奈川県）
/Kawashima Neurology Clinic (Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2032 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A periodic report was submitted to the Ethics Committee on March 4, 2026, and continued review was approved on March 5, 2026.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065905
