Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060994) titled 'Immediate mood improvement in cognitive stimulation therapy-A pilot randomized controlled trial-' on March 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Japan Community Healthcare Organization Gunma Central Hospital,Rehabilitation,Takanari Akiba
Condition:
Condition - Dementia
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 01 Day
Anticipated trial start date - 2026 Year 03 Month 30 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069726
Disclaimer: Curated by HT Syndication.