UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060994 |
|---|---|
| Receipt number | R000069726 |
| Scientific Title | Immediate mood improvement in cognitive stimulation therapy -A pilot randomized controlled trial- |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/16 17:51:47 |
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Basic information
Public title
Immediate mood improvement in cognitive stimulation therapy-A pilot randomized controlled trial-
Acronym
Immediate mood improvement in CST-A pilot RCT trial-
Scientific Title
Immediate mood improvement in cognitive stimulation therapy -A pilot randomized controlled trial-
Scientific Title:Acronym
Immediate mood improvement in CST -A pilot RCT trial-
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the feasibility of implementing an intervention using Cognitive Stimulation Therapy (CST) in hospitalized patients with dementia, with the aim of improving mood and alleviating depressive symptoms; to verify its initial effects; and to confirm the feasibility of conducting a full-scale randomized controlled trial (RCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-dimensional Mood Scale
Key secondary outcomes
Profile of Mood State 2(Depression-Dejection),Face Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to standard treatment, one hour of cognitive activation therapy is administered.
Interventions/Control_2
Only standard treatment will be performed.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing rehabilitation
2) Individuals diagnosed with Alzheimer's, Lewy body, vascular, frontotemporal dementia, or dementia of unknown type
3) Age 65 or older
4) Male or female
5) Native Japanese speakers
6) MMSE-J score under 10, indicating mild to moderate dementia
7) Individuals who have provided informed consent
8) Individuals capable of understanding the assessment
9) Individuals possessing sufficient language ability to undergo neuropsychological testing
10) Individuals possessing sufficient communication skills and comprehension to adapt to the group setting
Key exclusion criteria
1) Individuals with visual or hearing impairments severe enough to interfere with daily life
2) Individuals with severe aphasia
3) Individuals with impaired alertness
4) Individuals suffering from physical or mental illnesses severe enough to make participation difficult
5) Individuals in a state of agitation severe enough to make participation in CS difficult
6) Individuals suffering from mental illness
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Akiba |
Organization
Japan Community Healthcare Organization Gunma Central Hospital
Division name
Rehabilitation
Zip code
371-0025
Address
1-7-13, Kouncho, Maebashi Shi, Gumma, Japan
TEL
027-221-8165
akibatakanari@gmail.com
Public contact
Name of contact person
| 1st name | Takanari |
| Middle name | |
| Last name | Akiba |
Organization
Japan Community Healthcare Organization Gunma Central Hospital
Division name
Rehabilitation
Zip code
371-0025
Address
1-7-13, Kouncho, Maebashi Shi, Gumma, Japan
TEL
027-221-8165
Homepage URL
akibatakanari@gmail.com
Sponsor or person
Institute
Japan Community Healthcare Organization Gunma Central Hospital,Rehabilitation,Takanari Akiba
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Gunma Central Hospital,Nagano University of Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Healthcare Organization Gunma Central Hospital
Address
1-7-13, Kouncho, Maebashi Shi, Gumma, Japan
Tel
027-221-8165
akibatakanari@gmail.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 20 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069726
