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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia of Alzheimer Type; Cognitive Impairment, Mild; Dementia, Mild; Dementia Moderate; Dementia Frontal
• Intervention / Treatment: Behavioral: Referral for Cognitive Stimulation Therapy; Other: No change to Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Lepore, PhD; Phone Number: 410-706-3794; Email: mlepore@umaryland.edu
• Study Contact Backup: Name: Deanna Myer; Email: dmyer@umaryland.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Center on Aging
    • New Haven, Connecticut, United States, 06536
      • Yale Memory Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Referral for Cognitive Stimulation Therapy; This group will receive a referral from their physician for CST treatment	Behavioral: Referral for Cognitive Stimulation Therapy; Physician will review participant eligibility for CST treatment and offer referral based on clinical judgement
Placebo Comparator: Standard of Care; This group will receive standard of care and no CST referral.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive decline measured by an increase in Montreal Cognitive Assessment Score from baseline to follow-up	Clinically meaningful cognitive decline will be less common in intervention group than the control group. Clinically meaningful changes will be 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' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. An increase in the baseline MoCA score by 2 points or greater indicates a clinically meaningful decline in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive improvement measured by a decrease in Montreal Cognitive Assessment Score from baseline to follow-up	Clinically meaningful cognitive improvement will be more common in the intervention group than the control group. Clinically meaningful changes will be 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' will be used to convert all cognitive assessment measures to a MoCA score. All participants will start with a baseline MoCA score of 10 to 26 which indicates mild-moderate cognitive impairment. A decrease in the baseline MoCA score by 2 points or greater indicates a clinically meaningful improvement in cognitive status. Cognitive assessments will be collected at baseline and 6 months follow-up visit after baseline/enrollment. All cognitive assessments will be done by the study physicians. The cognitive assessment collected at baseline will be the cognitive assessment used to assess cognitive impairment at the 6 month follow-up.	6 months
Referral Acceptance Rate	V-CST referral will be favorably received by participants. V-CST referral will be assessed by referral acceptance rate measured by percentage of people referred for V-CST who accept the referral over the 1-month referral period process. This outcome will be assessed at the end of the referral process.	1 month
Participant attendance	V-CST treatment will be favorably received by participants. Participant attendance will be measured as the percentage of enrolled participants who attend each V-CST session. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.	7 weeks
Participant Attrition	V-CST treatment will be favorably received by participants. Participant attrition will be measured as the percentage of enrolled participants who cease attending V-CST between session 1 and session 14. V-CST sessions will be conducted over a 7-week period. This outcome will be assessed at the end of the 7th week V-CST session.	7 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: University of Maryland, Baltimore; Yale University; National Institute on Aging (NIA); UConn Health
• Investigators: Principal Investigator: Michael Lepore, PhD, University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Cognitive Dysfunction; Lewy Body Disease; Dementia, Vascular
• Other Study ID Numbers: Pro00054748; 5U54AG063546-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No