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NCT Number: NCT05860127

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.

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Key information

Conditions

Dementia Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment, Mild Dementia Frontal Dementia Moderate Dementia With Lewy Bodies Dementia of Alzheimer Type Dementia, Mild Dementia, Mixed Dementia, Vascular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Mixed Dementias Movement Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Center on Aging, Farmington, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referral for Cognitive Stimulation Therapy

Behavioral

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

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.

Primary outcomes

  1. Cognitive Impairment

    Time frame: 12 months

    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.

Secondary outcomes

  1. Percentage of Participants Who Accepted the Referral

    Time frame: 1 month

    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 from their physician over the 1-month referral period process. This outcome will be assessed at the end of the referral process. The referral process is defined by the physician offering the referral to participants, the acceptance of the referral then leads to the physician sending the referral to the CBO to follow up.

  2. Percentage of Participants Who Completed Cognitive Stimulation Therapy

    Time frame: 7 weeks

    Participant completion will be measured as the percentage of enrolled participants who attend V-CST as a completer. A participant is considered a V-CST completer if they attend at least 8 or more of V-CST sessions. This outcome will be assessed at the end of the final V-CST session. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST.

  3. Percentage of Participants Who Did Not Complete CST

    Time frame: 7 weeks

    V-CST treatment will be favorably received by participants. Of the 50 participants randomized to the intervention, 42 participants were referred for V-CST, with 16 participants agreeing to participate and enrolled in V-CST. 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.

Other outcomes

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

    Time frame: 12 months

    For each participant, we determined whether there was a decrease in psychotropic medications and no increase in psychotropic medications (i.e., favorable psychotropic medication outcomes), and then calculated the proportion of participants with favorable psychotropic medication outcomes across arms

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Collaborators

  • National Institute on Aging (NIA)
  • UConn Health
  • University of Maryland, Baltimore
  • Yale University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 16, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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