Clinical trial NCT06978972: Cognitive Stimulation Therapy for Residents With Dementia in Nursing Homes
Official title: Cognitive Stimulation Therapy for Residents With Dementia in Skilled Nursing Facilities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia in Nursing Home
Keywords: Skilled nursing facilities
occupational engagement
cognitive functioning
Cognitive stimulation therapy
dementia
Group intervention
long-term care
geriatrics
Lead sponsor: Northern Kentucky University
Sponsor class: OTHER
Collaborators: name: Ridgewood Health Campus
First posted: 2025-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this experimental study is to learn if cognitive stimulation therapy (CST) helps improve cognitive functioning and engagement in individuals with mild-to-moderate dementia who reside in skilled nursing facilities. It will also help introduce CST into long-term care facilities in the Northern Kentucky region and provide evidence to support reimbursement for occupational therapy (OT) services in memory care.

The main question it aims to answer is: Is there a significant difference in cognitive functioning and engagement between individuals with mild-to-moderate dementia who reside in skilled nursing facilities and receive cognitive stimulation compared to individuals receiving maintenance-level services?

Researchers will compare CST (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) to maintenance-level services (activities performed in the activities room) to see if there is a significant difference in cognition and engagement in residents who receive CST versus their regular maintenance level services.

Participants will receive either CST or maintenance-level services for 45-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 and the sites activity director, complete 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.

This study will also support the OT profession by enhancing practitioners' skills in dementia care and contributing evidence for policy and reimbursement discussions.

Detailed description: This study is a double-blind, randomized controlled trial designed to evaluate the significance of a 7-week Cognitive Stimulation Therapy (CST) program compared to continued maintenance-level care among residents of a skilled nursing facility with mild to moderate dementia. The primary aim is to assess the impact of CST on cognitive functioning and occupational engagement.

The study will be conducted at Ridgewood Health Campus and aims to enroll approximately 10 participants over an estimated period of 1-2 months. Recruitment has begin with research team members meeting site staff to present the study and prepare them to identify eligible individuals based on the inclusion criteria. Site staff will then provide a list of potential participants and access to relevant medical records, which the research team will review before reaching out to potential participants or their legal representatives via email, phone, or in person.

Interested participants or their Powers of Attorney (POAs) will receive an informational handout explaining study expectations. If the POA expresses interest in participation, an electronic version of the informed consent form, will be provided and reviewed. Research team members will be available to address questions via phone, email, Zoom, or in person. The signed consent form may be returned electronically, and a copy will be retained by the participant or their POA.

Once 10 participants are enrolled, they will be randomly assigned to either the intervention or control group using a computer-generated randomization list. Participants will first complete a one-week screening period, followed by one week of pre-testing. The CST intervention will be administered twice weekly for 45 minutes over 7 weeks, followed by a one-week post-intervention assessment period.

To ensure fidelity of the CST intervention, the Principal Investigator (PI) and Co-Investigators (Co-PIs) have completed formal training through the North American Cognitive Stimulation Therapy Training Institute. The CST practice manual will also be strictly followed. The research team will collaborate closely with on-site staff to address concerns related to participant safety, treatment environment, or study procedures. In the event of an adverse event, the research team will follow all HIPAA and facility protocols and report the incident to the PI.

Given the vulnerability of the participant population, the research team has prioritized ethical considerations. All study materials, including the participant handout and consent forms, are written in plain language and at an appropriate reading level. POAs are given adequate time and support to make informed decisions. Additionally, a licensed occupational therapist in the state of Indiana who is familiar with the participants will be present during sessions to help meet their individual needs and advocate on their behalf.

Participation is entirely voluntary, and participants may withdraw from the study at any time without penalty or loss of benefits. Participants may also decline individual sessions or activities without consequence. During evaluations, participants can skip any question they do not wish to answer. Data from assessments will be included in analysis only if at least 75% of items are completed. Likewise, if a participant attends at least 11 of the 14 scheduled CST sessions (\~75%), their data will be retained for analysis. Data from participants who attend fewer sessions or withdraw will be excluded from analysis, and this will be addressed in the final report.

CST has not been associated with harmful side effects in previous studies, suggesting minimal risk to participants. Nonetheless, the possibility of emotional discomfort or other adverse events remains. Psychological effects will be monitored, and any incident will be addressed promptly following institutional and facility procedures. A potential risk includes unintentional disclosure of identifiable information, although safeguards have been implemented to mitigate this.

Data collection will be managed using a password-protected flash drive with encryption and Google Sheets and OneDrive (Google Docs) documents. Participant names will be linked to unique ID codes necessary for tracking consent and study progress. Only coded identifiers will be used in outcome data collection. Names will be recorded solely on consent forms and a separate secure document linking names to ID codes, which will be stored for six years in accordance with data retention policies. After this period, all physical and electronic data will be securely destroyed.

Access to data is restricted to the PI and four (Collaborative Institutional Training Initiative program) CITI-certified research members. Documents are stored on a secure, shared, encrypted and password-protected flash drive. All team members' laptops are password-protected and use two-factor authentication. Devices are stored securely when not in use, and team members adhere to strict data security practices when in public settings.

All study procedures will comply with Northern Kentucky University's institutional ethical guidelines. Any protocol changes have been, and will continue to be, submitted to the Institutional Review Board (IRB) for approval. Data management follows validated protocols with comprehensive quality control measures to ensure the integrity and confidentiality of all collected data.

Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* Diagnosis of mild-to-moderate dementia according to the DSM-V as determined by a score of 10-25 on the MoCA
* Living in a long-term care facility
* Engaging in at least 45 minutes a week of recreational or social activities
* Aged 18 years or older
* Adequate English proficiency, vision, hearing, and speech to participate in groups
* Sufficient ability in communication to participate in assessments and CST sessions
* Scores in mid-range on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Exclusion Criteria:

* Prior CST treatment
* History of a learning disability or traumatic brain injury
* Participation in a concurrent clinical trial
* Receiving hospice care
* Scores in high-range on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions/maintenance level services (week of August 18th).
measure: The Observational Measurement of Engagement - OME Modified
timeFrame: From/after the completion of enrollment (middle to end of June 2025) to after the completion of the 7-week CST sessions/maintenance level services (week of August 18th).
Secondary outcomes:
Other outcomes:
Locations:
city: Lawrenceburg
country: United States
facility: Ridgewood Health Campus
state: Indiana
Study officials:
References: