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

University of Massachusetts, Amherst

Status: Active, not recruiting

Conditions: Dementia of Alzheimer Type; Dementia, Mild; Dementia Frontal; Dementia With Lewy Bodies; Dementia, Vascular; Cognitive Impairment, Mild; Dementia Moderate; Dementia; Dementia, Mixed

Treatments: Behavioral: Referral for Cognitive Stimulation Therapy; Other: No change to Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05860127

Pro00054748

5U54AG063546-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

133 participants in 2 patient groups, including a placebo group

Referral for Cognitive Stimulation Therapy

Active Comparator group

Description:

This group will receive a referral from their physician for CST treatment

Treatment:

Behavioral: Referral for Cognitive Stimulation Therapy

Standard of Care

Placebo Comparator group

Description:

This group will receive standard of care and no CST referral.

Treatment:

Other: No change to Standard of Care