DementiaNCT06180694
Reminiscence Therapy in Individuals With Dementia
A study testing Reminiscence therapy in people with Dementia, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Reminiscence therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Reminiscence therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence therapyOther
Reminiscence therapies will be applied to individuals with dementia in 45-minute sessions once a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Reminiscence group | Experimental | Reminiscence therapies will be applied to individuals with dementia Receives: Other: Reminiscence therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cognitive Status on the Standardized Mini Mental Test (SMMT) at 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)
Measured: Baseline and week 8
Change from Baseline in Anxiety Symptoms on Geriatric Anxiety Scale (GAS)
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)
Measured: Baseline and week 8
Change from Baseline in Depressive Symptoms on Geriatric Depression Scale Short Form (GDS-SF)
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)
Measured: Baseline and week 8
Change from Baseline in Patient's Dependency on Basic Self-Care Behaviors on Katz's Activities of Daily Living Index (KADLI)
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)
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start19 Aug 2024
- Primary completion20 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Merve çayır yılmaz, asst. prof., Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180694
- Sponsor's protocol ID
- amasyau-mçy-001
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminiscence Therapy Applied to Individuals With Dementia
- ClinicalTrials.gov ID
- NCT06180694
- Acronym / sponsor ID
- amasyau-mçy-001
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reminiscence group | Experimental | Other: Reminiscence therapyReminiscence therapies will be applied to individuals with dementia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminiscence therapyReminiscence therapies will be applied to individuals with dementia in 45-minute sessions once a week for 8 weeks. | Other | Reminiscence group |
Primary outcome
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)
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)
Change from Baseline in Depressive Symptoms on Geriatric Depression Scale Short Form (GDS-SF)
Time frame: Baseline and week 8
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve çayır yılmaz, asst. prof. principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence therapy in people with Dementia, run by Amasya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Cognitive Status on the Standardized Mini Mental Test (SMMT) at Week 8 (time frame: Baseline and week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.