Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058421) titled 'A Randomized Controlled Trial of a Psychosocial Support Program Using a Recreation-Based Approach with Music and Comedy for People with Mild Cognitive Impairment or Dementia and Their Carers' on July 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Mild Cognitive Impairment, Dementia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A randomized controlled trial will be conducted to evaluate the effectiveness of a psychosocial support program for individuals with mild cognitive impairment or dementia Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 1: Participants in the intervention program will consist of pairs of individuals with dementia and their family caregivers. 2: The program is a psychosocial support program composed of a hybrid team of professionals and non-professionals, delivered as a multi-component intervention consisting of six sessions: three music sessions and three comedy (manzai) sessions. 3: Each session will be held once every two weeks, lasting 120 minutes per session, for a total of six sessions over a 12-week period. 4: The program is based on reminiscence therapy, stress management theory, and a recreation-based approach that incorporates the elicitation of laughter. 5: Of the 120 minutes, a 40-minute separate session will be included. During this time, the individual with dementia will continue with the main joint session activities, while the family caregiver will participate in a group session where they (a) observe the individual's behavior during the session, (b) reflect and share their impressions, and (c) engage in discussion with care professionals to explore better caregiving approaches for persons with MCI or dementia. The session will also include peer interaction where caregivers can exchange concerns and support each other. The text used for this part is the caregiver support guide. Interventions/Control_2 - *Educational materials selected from the following sources will be adapted to align with the intervention sessions and distributed every two weeks at each intervention site: Introductory Textbook for People with Dementia and Their Family Caregivers and For Family Members Supporting a Person with Dementia both distributed at the Memory Clinic of the National Center for Geriatrics and Gerontology as well as handouts used in the control group of the Petit Salon psychosocial educational support program for individuals with mild cognitive impairment or dementia and their family caregivers.

*A total of six handouts will be distributed. For the first and sixth distributions, a follow-up phone call will be made a few days after the materials are handed out to confirm whether the recipients have read them. For the second through fifth distributions, at the time of handout delivery, participants will be asked to share their impressions of the previous material, and their responses will be used to assess whether the content was read, based on the level of consistency.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - [Individuals with MCI or Dementia] Eligible participants are those aged 65-90, living at home, with a clinical diagnosis of MCI or mild to moderate dementia (MMSE >= 15), and who consent to participate (either directly or via a legal representative). They must meet at least one of the following:

- Outpatient at the National Center for Geriatrics and Gerontology (NCGG) - Completed caregiver education or "Petit Salon" at NCGG - Applied via NCGG website or posters - Applied via Kyoto City public notice - Applied via Ritsumeikan University website - Receiving support from dementia coordinators or care managers in Kyoto Prefecture - Applied via Kusatsu City public notice - Receiving support from coordinators or care managers in Kusatsu City

[Families] - Aged 20-90, family caregiver of a person meeting the above criteria, able to attend all sessions with the individual, and has consented to join - Main caregiver providing daily support, regardless of co-residence Key exclusion criteria - [Individuals with MCI or Dementia]

*MMSE score of 14 or lower

*Individuals with severe aphasia

*Individuals with severe visual and auditory impairments

*Individuals with severe neurodegenerative diseases or psychiatric disorders who are deemed by their primary physician to be unsuitable for participation

*Individuals with progressive illnesses (e.g., cancer) for whom long-term survival is unlikely

*Individuals unable to understand the purpose of the study

*Individuals who cannot provide informed consent or whose legal representative cannot provide proxy consent

*Individuals currently residing in care facilities

*Individuals currently participating in any of the following programs at the National Center for Geriatrics and Gerontology: (A) Cognitive and Physical Vitalization Rehabilitation Program (B) Art Appreciation and Self-Expression Program

[Family Caregivers] - Exclusion Criteria

*Individuals working as medical or long-term care professionals

*Individuals with severe aphasia

*Individuals with severe visual and auditory impairments

*Individuals with severe neurodegenerative diseases or psychiatric disorders who are deemed by their primary physician to be unsuitable for participation

*Individuals with progressive illnesses (e.g., cancer) for whom long-term survival is unlikely

*Individuals unable to understand the purpose of the study

*Individuals currently participating in any of the following programs at the National Center for Geriatrics and Gerontology: (A) Cognitive and Physical Vitalization Rehabilitation Program (B) Art Appreciation and Self-Expression Program Target Size - 200

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2022 Year 08 Month 15 Day Date of IRB - 2022 Year 12 Month 13 Day Anticipated trial start date - 2023 Year 01 Month 10 Day Last follow-up date - 2025 Year 10 Month 11 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066784

Disclaimer: Curated by HT Syndication.