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

NCT05860127 | Completed Results

• 2 other identifiers: Pro000547485U54AG063546-04
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Cognitive Impairment

  Cognitive Impairment was assessed using one of the following cognitive assessment tools: Montreal Cognitive Assessment (MoCA), Saint Louis University Mental Status (SLUMS) exam, or the Mini-Mental State Examination (MMSE). A 'crosswalk' was used to convert all cognitive assessment measures to a MoCA score. MoCA scores range from 0-30, with 26+ generally considered normal, while scores below that suggest cognitive issues: 18-25 is often mild impairment, 10-17 is moderate, and under 10 is severe impairment. All participants started with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment.

  12 months

Secondary Outcomes (3)

• Percentage of Participants Who Accepted the Referral

  1 month

• Percentage of Participants Who Completed Cognitive Stimulation Therapy

  7 weeks

• Percentage of Participants Who Did Not Complete CST

  7 weeks

Other Outcomes (1)

• Percentage of Participants With a Decrease and With no Increase in Psychotropic Medications

  12 months

Study Arms (2)

Referral for Cognitive Stimulation Therapy

ACTIVE COMPARATOR

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

Behavioral: Referral for Cognitive Stimulation Therapy

Standard of Care

PLACEBO COMPARATOR

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

Other: No change to Standard of Care

Interventions

Referral for Cognitive Stimulation Therapy BEHAVIORAL

Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement

Referral for Cognitive Stimulation Therapy

No change to Standard of Care OTHER

Participants will not receive referral from a physician. They will continue with standard of care at their site.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• Yale University: collaborator
• UConn Health: collaborator
• National Institute on Aging (NIA): collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (2)

UConn Center on Aging

Farmington, Connecticut, 06030, United States

Location

Yale Memory Clinic

New Haven, Connecticut, 06536, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Dementia, Vascular; Mixed Dementias; Lewy Body Disease; Lymphoma, Follicular

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Limitations and Caveats

A shortcoming was a high rate of missing follow-up cognitive assessment data.

Results Point of Contact

• Title: Dr. Michael Lepore
• Organization: University of Massachusetts Amherst

mjlepore@umass.edu

4135455093

Study Officials

• Michael Lepore, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: May 16, 2023
• Study Start: April 10, 2023
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)