Cognitive Stimulation Therapy for Residents With Dementia in Nursing Homes

NCT06978972 | Completed

• 1 other identifier: IRB#: 2562
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this experimental study was to evaluate whether cognitive stimulation therapy (CST) improved cognitive functioning and engagement levels in individuals with mild-to-moderate dementia residing in long-term care facilities. The study aimed to: 1) investigate the preliminary effect of CST on cognition and engagement in individuals with mild-to-moderate dementia, and 2) assess the feasibility of implementing CST in LTC facilities in the Cincinnati metropolitan area. The main question the study answered was: Does CST improve cognitive functioning and increase engagement levels in individuals with mild-to-moderate dementia living in long-term care facilities? Researchers conducted CST (structured, themed, grouped sessions with activites related to their childhood, sounds, word and number games, current affairs, being creative, word association, physical games, quizzes, and orientation) sessions to see if there was a significant increase in cognition and engagement after the 7 weeks of activites. Participants received CST for 45 to 60 minutes twice weekly for 7 weeks, led by two doctor of occupational therapy students under the supervision of a licensed occupational therapist in the state of Indiana. Participants completed assessments before and after the 7-weeks to measure changes in cognitive function and engagement, along with participating in a screening assessment before the start of the study.

Conditions

Dementia in Nursing Home

Keywords

Skilled nursing facilities; occupational engagement; cognitive functioning; Cognitive stimulation therapy; dementia; Group intervention; long-term care; geriatrics

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Assessment (MoCA)

  The MoCA assesses multiple areas of cognition such as attention, orientation, delayed recall, working memory, executive functioning, visuospatial, and language. The MoCA will take approximately 10 minutes to administer. MoCA scores range from 0 to 30, with higher scores indicating better cognitive functioning. Scores between 10 and 25 typically reflect mild to moderate cognitive impairment, and a score within this range is required for study inclusion. Therefore, only participants scoring between 10 and 25 at baseline will be enrolled, and we will assess whether their cognitive functioning improves from this initial range over the seven weeks.

  From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).

• The Observational Measurement of Engagement - OME Modified

  The OME is a measurement tool used for individuals with dementia to document direct observations regarding their level of engagement during an activity. The OME assesses an individual's response to the stimuli during an activity by taking note of their attention and attitude using a rating scale. The OME also assesses the individual's cognitive and fine motor difficulty during the task, as well as, the duration and frequency of interactions in the task to determine overall engagement. The OME will take between 3 and 15 minutes to administer. Three minutes if the participant is disengaged with the stimulus and 15 minutes if the participant is engaged the entire time. The OME Modified scoring system includes variable ranges depending on the domain assessed. For attitude and attention, scores range from 1 to 7, with higher scores indicating better outcomes. For activity, scores range from 0 to 3, where a score of 3 represents a greater time the participant was manifesting the activites.

  From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions (week of August 18th).

Study Arms (1)

Cognitive stimulation therapy group

EXPERIMENTAL

The CST group will participate in a screening measure where they will perform the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) to assess for cognitive impairment. The participants will then participate in the Montreal Cognitive Assessment (MoCA) and the Observational Measurement of Engagement (OME) prior to and after the 7-week CST program. The group will receive CST, which is an evidence-based, cognitively stimulating therapeutic group intervention, two times per week for 7 weeks for 45 minutes. The general structure of each session will follow the CST Manual called "Making a Difference 1" and each participant will participate in an introduction, theme song, current affairs activity, the main activity (theme-based activities), and closure each session.

Other: Cognitive Stimulation Therapy

Interventions

Cognitive Stimulation Therapy OTHER

CST is an evidence-based, cognitively stimulating therapeutic group intervention for individuals with mild-to-moderate dementia. Individuals participate in CST 2 times per week for 7 weeks. The CST sessions are administered by a variety of professionals who become certified through the St. Louis School of Medicine. The general structure of each session will follow the CST Manual called "Making a Difference 1". Each session will be based on a theme and will include an introduction, theme song, current affairs activity, the main activity (physical games, sounds, food, being creative, word and number games, team quizzes, orientation, current affairs, ect.), suggested activities for home, and closure. These sessions are highly structured and will follow the introduction, theme song, current affairs activity, the main activity, suggested activities for home, and closure organization strictly. The participants will spend 45 minutes in each session.

Cognitive stimulation therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Adults aged 18 years or older who reside in a long-term care facility
• Adequate English proficiency, vision, hearing, and speech to participate in groups
• English proficiency
• participation in recreational or social activities for at least 45 minutes per week
• diagnosis of mild-to-moderate dementia based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria, confirmed by medical records, or a mid-range score (18-55) on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

You may not qualify if:

• Prior CST treatment
• non-English speaking
• Communication barriers (aphasia)
• Diagnosis of severe dementia
• History of a learning disability or traumatic brain injury
• Participation in a concurrent clinical trial
• Receiving hospice care
• ADAS-Cog score in the no-impairment range (0-17) or high range (56-70).

Sponsors & Collaborators

• Northern Kentucky University: lead
• Ridgewood Health Campus: collaborator

Study Sites (1)

Ridgewood Health Campus

Lawrenceburg, Indiana, 47025, United States

Location

Related Links

• St. Louis School of Medicine: Cognitive Stimulation Therapy (CST) and Individual Cognitive Stimulation Therapy (iCST)

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Occupational Therapy Student

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 18, 2025
• Study Start: May 14, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Unending (Beginning after the publication of our study, with no end date).
• Access Criteria: Future doctor of occupational therapy students at Northern Kentucky University who are interested in further developing research in this domain will be able to access IPD and supporting information. They can access all supporting information via our password-protected flash drive, where we are storing all of the data and study information.

Locations

US (1)