Cognitive Stimulation Therapy for Dementia

Recruiting at 1 trial location

Overseen By Deanna Myer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Amherst

Disqualifiers: Auditory impairment, Visual impairment, Combative behaviors, others

Compensation: Varies

Number of Visits: 14

Duration: 7 weeks

133 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a non-drug therapy, so it's likely you can continue your current medications, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Cognitive Stimulation Therapy for dementia?

Research shows that Cognitive Stimulation Therapy (CST) can improve thinking skills and quality of life for people with mild to moderate dementia. However, the studies vary in quality, and more high-quality research is needed to confirm these findings. ^{1 2 3 4 5}

Is Cognitive Stimulation Therapy safe for humans?

Cognitive Stimulation Therapy (CST) is widely used and recommended for people with mild to moderate dementia, and it is considered safe as it is a non-drug, evidence-based approach to improve cognitive function and quality of life. ^{3 5 6 7 8}

How is Cognitive Stimulation Therapy different from other treatments for dementia?

Cognitive Stimulation Therapy (CST) is unique because it is a non-drug treatment that involves group activities designed to stimulate thinking and memory in people with mild to moderate dementia. Unlike medications, CST focuses on engaging different parts of the brain through social interaction and mental exercises, making it a recommended option alongside any prescribed drugs. ^{3 6 7 9 10}

Research Team

Michael Lepore, PhD

Principal Investigator

University of Massachusetts, Amherst

Eligibility Criteria

This trial is for English-speaking individuals with mild to moderate dementia, as indicated by certain cognitive test scores. They must have a scheduled visit for cognitive screening within 6-12 months and not have participated in V-CST before. Those without online access or necessary caregiver support, or who have impairments that interfere with group therapy are excluded.

Inclusion Criteria

Your test scores for memory and thinking fall within a certain range, which was recorded less than 24 months ago.

Visit scheduled to include cognitive screening 6 to 12 months after record review.

English-speaking

Exclusion Criteria

No access to online meeting platform

My doctor says I need help to participate in a study, but I don't have anyone to assist with technology.

I have chosen not to participate in research or share my data for research.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Referral

Participants receive a referral for Cognitive Stimulation Therapy (CST) from their clinical providers

1 month

Treatment

Participants undergo Virtual Cognitive Stimulation Therapy (V-CST) sessions

7 weeks

14 sessions (virtual)

Follow-up

Participants are monitored for cognitive changes using assessments like MoCA, SLUMS, and MMSE

6 months

Treatment Details

Interventions

• Cognitive Stimulation Therapy

Trial Overview The trial tests if Cognitive Stimulation Therapy (CST) delivered virtually can slow down cognitive decline in dementia patients compared to standard care. Participants will be randomly assigned to either receive a referral for virtual CST or continue with their usual treatment without changes.

Participant Groups

Group I: Referral for Cognitive Stimulation Therapy Active Control 1 Intervention

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

Group II: Standard of Care Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Massachusetts, Amherst

Lead Sponsor

Trials

83

Recruited

3,474,000+

UConn Health

Collaborator

Trials

218

Recruited

59,100+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Efficacy of cognitive stimulation therapy in patients with dementia]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive Stimulation Therapy in a Veteran Sample: A Program Evaluation Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Staff training and outreach support for Cognitive Stimulation Therapy and its implementation in practice: a cluster randomised trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Stimulation Therapy for Older Adults With Mild-to-Moderate Dementia in Italy: Effects on Cognitive Functioning, and on Emotional and Neuropsychiatric Symptoms. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive stimulation therapy for older adults with vascular dementia. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Education. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Validation of the cognitive stimulation therapy (CST) program for people with dementia in Portugal. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Can education and training improve the adoption of a psychosocial group treatment by dementia services? [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive Stimulation Program Presented Through New Technologies in a Group of People with Moderate Cognitive Impairment. [2022]