Skip to main content
OpenTrials
Completed

NCT Number: NCT04754932

Implementation of Cognitive Stimulation Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham Center for Senior Life, Durham, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cognitive Stimulation Therapy

Other

Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.

Primary outcomes

  1. Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation

    Time frame: 2 years

  2. Change in cognitive status as measured by Saint Louis University Mental Status Examination

    Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month

    A validated 30 point office-based cognitive screen

  3. Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia

    Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month

    A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.

  4. Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)

    Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month

    A 5-point scale measuring general well-being/quality of life for older adults

  5. Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory

    Time frame: Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month

    A validated 12-domain questionnaire to assess dementia-related behavioral symptoms

  6. Adoption as measured by the percentage of non-participating centers to the total number approached.

    Time frame: 2 years

  7. Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.

    Time frame: 1 year

  8. Maintenance as measured by percentage of long-term attrition

    Time frame: 2 years

  9. Assess the barriers and facilitators to implementation of CST in community settings

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Apr 14, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.