N/A
Completed N=133
Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
Dementia · Cognitive Impairment, Mild · Dementia, Vascular · Dementia, Mixed
Source: ClinicalTrials.gov NCT05860127 ↗
Enrolled (actual)
133
Serious AEs
11.3%
Results posted
Mar 2026
Primary outcomePrimary: Cognitive Impairment — 19; 19 Score on a scale — p=<0.05
Summary
Cognitive Stimulation Therapy (CST) is an evidence-based non-pharmacological group therapy shown to benefit people with mild to moderate dementia. Despite increasing availability of CST worldwide, access remains limited in the United States. This pilot pragmatic trial will embed CST referral into the standard care protocol of health care settings that serve people living with dementia in the state of Connecticut, and evaluate online delivery of CST known as virtual CST (V-CST), and assess the acceptability of V-CST to people living with dementia.
The study design is a two-armed randomized embedded pragmatic clinical trial (ePCT). The trial aims to determine if cognitive decline is experienced less commonly among V-CST participants than control group members based on three widely used measures of cognition, the Montreal Cognitive Assessment (MoCA), St. Louis University Memory Screen (SLUMS), and Mini Mental State Exam (MMSE).
The study population will be persons with mild to moderate dementia identified by clinicians in standard care. From this population, subject participants will be randomized to intervention and control groups. Patients randomly assigned to the intervention group will be referred by their clinical providers to participate in V-CST, and those who accept the referral will participate in the intervention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Impairment |
19; 19 | <0.05 sig |
| SECONDARY Percentage of Participants Who Accepted the Referral |
42; 5; 3 | — |
| SECONDARY Percentage of Participants Who Completed Cognitive Stimulation Therapy |
16; 9; 7 | — |
| SECONDARY Percentage of Participants Who Did Not Complete CST |
9; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Mild Cognitive Impairment or Mild to Moderate Dementia
- MoCA score of 10 to 26 OR SLUMS score of 10 to 26 OR MMSE score between 13 and 24 recorded as present < 24 months before the record review
- English-speaking
- Visit scheduled to include cognitive screening 6 to 12 months after record review.
Exclusion Criteria
- Auditory or visual impairment, combative behaviors, or other clinician-assessed condition that would interfere with group treatment
- No access to online meeting platform
- Patient has specified to HCS not to engage patient in research or to use patient data in research
- Patient has previously participated in V-CST
- Physician determines a caregiver is needed to support V-CST participation, but no caregiver available to assist with technology.
Data sourced from ClinicalTrials.gov (NCT05860127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.