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Implementation of Cognitive Stimulation Therapy

Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04754932
Enrollment
23
Registered
2021-02-15
Start date
2021-05-27
Completion date
2022-09-30
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief summary

This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.

Interventions

Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL * has a SLUMS score greater than 10.

Exclusion criteria

* unable to hold a meaningful conversation, * unable to hear well enough to participate in a small group discussion * severe visual impairment that precludes ability to see most pictures * unable to remain in a group setting for 45 minutes

Design outcomes

Primary

MeasureTime frameDescription
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation2 years
Change in cognitive status as measured by Saint Louis University Mental Status ExaminationBaseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-monthA validated 30 point office-based cognitive screen
Change in anxiety/depression as measured by Cornell Scale for Depression in DementiaBaseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-monthA validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-monthA 5-point scale measuring general well-being/quality of life for older adults
Change in behavioral symptom severity as measured by the Neuropsychiatric InventoryBaseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-monthA validated 12-domain questionnaire to assess dementia-related behavioral symptoms
Adoption as measured by the percentage of non-participating centers to the total number approached.2 years
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.1 year
Maintenance as measured by percentage of long-term attrition2 years
Assess the barriers and facilitators to implementation of CST in community settings1 yearFocus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention. Implementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026