Implementation of Cognitive Stimulation Therapy

Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses

This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: Cognitive Stimulation Therapy

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Durham Center for Senior Life
    • Durham, North Carolina, United States, 27703
      • Program for All Inclusive Care of the Elderly
    • Durham, North Carolina, United States, 27705
      • The Forest at Duke
    • Greensboro, North Carolina, United States, 27405
      • Program for All Inclusive Care of the Elderly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL
• has a SLUMS score greater than 10.

Exclusion Criteria:

• unable to hold a meaningful conversation,
• unable to hear well enough to participate in a small group discussion
• severe visual impairment that precludes ability to see most pictures
• unable to remain in a group setting for 45 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Site 1; CST Implementation community site	Other: Cognitive Stimulation Therapy; Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 2; CST Implementation community site	Other: Cognitive Stimulation Therapy; Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 3; CST Implementation community site	Other: Cognitive Stimulation Therapy; Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 4; CST Implementation community site	Other: Cognitive Stimulation Therapy; Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
Experimental: Community Site 5; CST Implementation community site	Other: Cognitive Stimulation Therapy; Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation		2 years
Change in cognitive status as measured by Saint Louis University Mental Status Examination	A validated 30 point office-based cognitive screen	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia	A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)	A 5-point scale measuring general well-being/quality of life for older adults	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory	A validated 12-domain questionnaire to assess dementia-related behavioral symptoms	Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month
Adoption as measured by the percentage of non-participating centers to the total number approached.		2 years
Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.		1 year
Maintenance as measured by percentage of long-term attrition		2 years
Assess the barriers and facilitators to implementation of CST in community settings	Focus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention. Implementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.	1 year

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: Pro00106751

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