Trials / Completed
CompletedNCT05860127
Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- University of Massachusetts, Amherst · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Dementia
- Cognitive Impairment, Mild
- Dementia, Vascular
- Dementia, Mixed
- Dementia With Lewy Bodies
- Dementia Frontal
- Dementia Moderate
- Dementia of Alzheimer Type
- Dementia, Mild
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Referral for Cognitive Stimulation Therapy | Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement |
| OTHER | No change to Standard of Care | Participants will not receive referral from a physician. They will continue with standard of care at their site. |
Timeline
- Start date
- 2023-04-10
- Primary completion
- 2025-06-12
- Completion
- 2025-06-12
- First posted
- 2023-05-16
- Last updated
- 2026-03-23
- Results posted
- 2026-03-23
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05860127. Inclusion in this directory is not an endorsement.