Clinical trial NCT05808530: Cognitive Stimulation Therapy
Official title: The Effect of Cognitive Stimulation Therapy on Apathy, Loneliness, Anxiety and Activities of Daily Living in Elderly Individuals Diagnosed With Alzheimer's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease 10
Dementia
Apathy
Anxiety
Loneliness
Keywords: Alzheimer Disease
Dementia
Apathy
Anxiety
Loneliness
Cognitive Stimulation Therapy
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 56
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The concept of cognitive stimulation in AD is one of the most popular approaches. Cognitive Stimulation Therapy (CST) is stated to be evidence-based best practice with robust clinical trials, administered according to specific guidelines for individuals with mild to moderate dementia. In this study, it was aimed to investigate the effects of CST application on the levels of apathy, loneliness, anxiety and daily living activities in elderly individuals with Alzheimer's disease.

This research was planned in an experimental research design with a single center and pretest posttest control group. The research was planned to be carried out between January 2023 and June 202 at the Moral House of Gaziantep Metropolitan Municipality, Department of Disabled and Health Services. Introductory Information Form, Standardized Mini-Mental Test, Geriatric Anxiety Scale, Apathy Rating Scale, Loneliness Scale and Functional Disability in Dementia Scale will be used in the research. CST will be administered by a researcher trained in therapy, 2 days a week, for a total of 14 sessions of 45-50 minutes. There will be a pre-test before the application, an intermediate test right after the application, and a post-test three months later. Research data will be evaluated in SPSS 25.0 New York package program.

Detailed description: Alzheimer's Disease is an insidious onset and slowly progressive disease, characterized by the presence of cognitive, behavioral and general dysfunction. Among the neuropsychiatric and behavioral symptoms seen in Alzheimer's patients, apathy is the most common symptom. It is also followed by depression, aggression, anxiety and sleep disorders. Behavioral and psychological symptoms (BPSD) affect up to 90% of people with dementia during the illness. Therefore, it brings great difficulties to both patients and their caregivers and causes low quality of life. In addition, the inability to treat the disease completely worsens this situation. Considering the pharmacological treatment of psychological symptoms such as apathy, anxiety, depression in AD individuals, the existence of adverse side effects, increased mortality, limited drug efficacy, relatively high cost, and the inability to effectively treat some of the most distressing behaviors, it is recommended to give priority to non-pharmacological interventions.

The concept of cognitive stimulation in AD is one of the most popular approaches. It is stated that Cognitive Stimulation Therapy (CST) is the best evidence-based practice with robust clinical trials, applied according to a specific guideline for individuals with mild and moderate dementia. In addition, CST is the only intervention recommended by the UK's National Institute for Clinical Excellence (NICE) to promote cognition, independence and well-being for people with mild to moderate dementia. It has been determined that CST has many effects on individuals with Alzheimer's disease. However, there are different results in studies on the effectiveness of cognitive intervention strategies aimed at reducing cognitive functions, behavioral and psychiatric symptoms. To enable the conversion of CST into routine clinical practice, practice research to support the standardization and generalization of cognitive stimulation therapy planned for patients with AD and its impact on improving neuropsychiatric symptoms and daily living skills requires further research. In addition, the absence of a widely used standard guideline for pharmacological methods for patients with AD in our country reveals that the planned study will contribute to practice. It has been confirmed by many studies that CST applied to individuals with AD contributes to the strengthening of cognitive, psychological and social aspects, but there are few studies applied by nurses. It is noteworthy that the studies on the CST program applied by nurses in our country are limited. Therefore, the need for more clinical studies is emphasized by nurses to build and disseminate knowledge in this area, as the intervention has been little studied. In addition, the absence of a widely used standard guideline for pharmacological methods for patients with AD in our country reveals that the planned study will contribute to practice. In this study, it is aimed to investigate the effect of CST application on the levels of apathy, loneliness, anxiety and daily living activities in elderly individuals diagnosed with Alzheimer's.

This research was planned in a single center and experimental research design with pretest posttest control group. The research was planned to be carried out between January 2023 and June 202 at the Moral House affiliated to Gaziantep Metropolitan Municipality Disabled and Health Services Department. Introductory Information Form, Standardized Mini-Mental Test, Geriatric Anxiety Scale, Apathy Rating Scale, Loneliness Scale and Functional Disability in Dementia Scale will be used in the research. CST will be applied by a trained researcher in therapy, 2 days a week, in a total of 14 sessions of 45-50 minutes. There will be a pre-test before the application, an intermediate test right after the application, and a post-test three months later. Research data will be evaluated in SPSS 25.0 New York package program.

Eligibility criteria: Inclusion Criteria:

* 60 years or older,
* Having a mild Alzheimer's diagnosis and a Standardized Mini Mental Test score in the range of 18-23,
* Able to speak and understand Turkish,
* Hearing, understanding, seeing and speaking problems,
* Having no physical illness or disability to participate in group work,
* Have not participated in the CST program before, Individuals who volunteer to participate in the research will be included in the study.

Exclusion Criteria:

* Not meeting any of the research inclusion criteria,
* Have not attended at least two sessions of the CST program,
* Patients who refuse/want to leave the CST program will be excluded from the study by the investigator.

Primary outcomes:
measure: The effect of CST on the level of apathy in Alzheimer's patients
timeFrame: through study completion, an average of 1 year
measure: The effect of CST on the level of loneliness in Alzheimer's patients
timeFrame: through study completion, an average of 1 year
measure: The effect of CST on the level of anxiety in Alzheimer's patients
timeFrame: through study completion, an average of 1 year
measure: The effect of CST on the level of Activities of Daily Living in Alzheimer's patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
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