- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06180694
Reminiscence Therapy in Individuals With Dementia
April 14, 2025 updated by: Amasya University
Reminiscence Therapy Applied to Individuals With Dementia
This research will be carried out with the aim of determining the effect of reminiscence therapy applied to individuals with dementia on cognitive functions, anxiety, depression and activities of daily living.
The research will be conducted with a pre-test post-test single group, quasi-experimental research design.
Study Overview
Detailed Description
Dementia; It is a disease that requires intensive use of health services, has a high care burden, and has medical, social, psychological and economic burdens for the patient, family and society.
Dementia is characterized by many disorders in cognitive functions, especially memory, thought and social skills.
Progressive disorders in cognitive functions cause behavioral changes, decrease in activities of daily living, and neuropsychiatric symptoms such as anxiety and depression.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amasya, Turkey
- Merve Çayır Yılmaz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being diagnosed with mild to moderate dementia according to DSM-5 criteria (whether individuals have an official diagnosis of neurocognitive disorder according to DSM-5 criteria and their medical diagnosis will be verified from the health records at the institution),
- Getting a score between 13-23 for the educated (literate) and 10-23 for the uneducated (illiterate) on the mini mental state examination,
- Being 65 years of age or older,
- Being able to communicate,
- No vision or hearing problems,
- Consent to participate in the research.
Exclusion Criteria:
- Getting a score below 13 and above 23 for the educated (literate) and below 10 and above 23 for the uneducated (illiterate) from the mini mental state examination,
- Having an acute illness that prevents participation in intervention sessions,
- Having serious sensory and physical limitations that prevent participation,
- Having severe neuropsychiatric symptoms (agitation, psychosis, apathy, uncontrolled delirium, etc.),
- Having a traumatic life history,
- Having recently participated in a similar program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reminiscence group
Reminiscence therapies will be applied to individuals with dementia
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Reminiscence therapies will be applied to individuals with dementia in 45-minute sessions once a week for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Cognitive Status on the Standardized Mini Mental Test (SMMT) at Week 8
Time Frame: Baseline and week 8
|
SMMT, which allows assessing cognitive status, is the most frequently used and easily applied test in dementia screening.
The scale is evaluated out of 30 points in total.
For SMMT, scores of 23/24 are considered the cutoff score for dementia, but traditionally scores between 24 and 30 are considered normal.
A score below 24 indicates cognitive impairment, between 18 and 23 points is considered mild dementia, between 13 and 17 points is considered moderate dementia, and below 12 points is considered severe dementia.
Change = (Week 8 Score-Baseline Score)
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Baseline and week 8
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Change from Baseline in Anxiety Symptoms on Geriatric Anxiety Scale (GAS)
Time Frame: Baseline and week 8
|
GAS,developed for the elderly, is a 30-item scale that has somatic, cognitive and affective subscales and monitors anxiety symptoms.
The total score on the scale varies between 0-75.
A high score indicates a high level of anxiety.Change = (Week 8 Score-Baseline Score)
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Baseline and week 8
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Change from Baseline in Depressive Symptoms on Geriatric Depression Scale Short Form (GDS-SF)
Time Frame: Baseline and week 8
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GDS-SF, is a scale consisting of 15 questions that questions the emotional state of elderly individuals.
The cut-off point of the scale is 7 points and above.
Scores between 0 and 4 indicate no depressive symptoms, scores between 5 and 8 indicate mild depressive symptoms, scores between 9 and 11 indicate moderate depressive symptoms, and scores of 12 and above indicate severe depressive symptoms.
Change = (Week 8 Score-Baseline Score)
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Baseline and week 8
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Change from Baseline in Patient's Dependency on Basic Self-Care Behaviors on Katz's Activities of Daily Living Index (KADLI)
Time Frame: Baseline and week 8
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KADLI, evaluates the patient's dependence on basic self-care behaviors that are required to live and are expected to do every day.
The scale evaluates the degree of dependency in basic daily living activity parameters, including information on bathing, dressing, toileting, transfer, continence and nutrition.
Scoring of the index ranges from 0 to 6, and a patient with a score of 6 is considered independent, and a patient with a score of 0 is considered fully dependent.
Change = (Week 8 Score-Baseline Score)
|
Baseline and week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merve çayır yılmaz, asst. prof., Amasya University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 19, 2024
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
November 20, 2024
Study Registration Dates
First Submitted
December 13, 2023
First Submitted That Met QC Criteria
December 13, 2023
First Posted (Actual)
December 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2025
Last Update Submitted That Met QC Criteria
April 14, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- amasyau-mçy-001
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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