Cognitive Stimulation Therapy for Dementia: A Two-Armed Pragmatic Trial

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

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.

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• UConn Health

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• University of Maryland, Baltimore

  collaborator OTHER

• University of Massachusetts, Amherst

  lead OTHER

Principal Investigators

• Michael Lepore, PhD · University of Massachusetts, Amherst

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-10

Primary Completion

2025-06-12

Completion

2025-06-12

Countries

• United States

Study Locations