DementiaNCT07073443
Evaluation of the Effect of Memory-based Reminiscence Therapy
A study testing Experimental: Memory Therapy Group in people with Dementia and Memory, Short-Term, run by Kahramanmaraş İstiklal University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study is to examine the effects of memory-based recall therapy applied to elderly adults diagnosed with Stage 0, 1, and 2 dementia on their mental state, psychological flexibility, and cognitive flexibility. The original flow plan created in the study is not found in the literature. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Memory, Short-Term
- What is being tested?
- Experimental: Memory Therapy Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Receiving outpatient treatment for dementia from the relevant departments of hospitals
- At the time of the interviews, the doctor must have diagnosed mild dementia. (Stages 0, 1, and 2)
- No problems with understanding or speaking Turkish
- Being literate
- Being in the 65 and older age group
- No other psychiatric or neurological disorders
Who cannot join
- Not having been diagnosed with dementia during the study
- Having other chronic cognitive and psychiatric illnesses
- Being in an advanced stage of dementia
- Those who withdrew from the study during the interview or refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Istiklal Universty
Kahramanmaraş
About this study
Official title: Evaluation of the Effect of Memory-based Reminiscence Therapy on Cognitive Status, Psychological Flexibility and Cognitive Flexibility in Older People With Dementia
The main objective of this study is to examine the effects of memory-based recall therapy applied to elderly adults diagnosed with Stage 0, 1, and 2 dementia on their mental state, psychological flexibility, and cognitive flexibility.
The original flow plan created in the study is not found in the literature. Therefore, presenting the effects of memory-based recall on cognition in the literature may demonstrate that the contents of classical recall therapy can also be effectively restructured with cognitive effects. From this perspective, the aim is to make recommendations for "advanced psychiatric nursing practices."
Read more
Research Hypotheses:
H0: Memory-based recall therapy has no effect on mental state, psychological flexibility, and cognitive flexibility in individuals with early-stage dementia.
H1: Memory-based Recall Therapy has an effect on mental state, psychological flexibility, and cognitive flexibility in individuals with early-stage dementia.
Read the detailed description
Memory therapy is very important for elderly people with declining cognitive functions, as it can stimulate various senses such as touch, taste, and smell. Materials that facilitate recall can be used in therapy. Physical objects that the elderly can look at and touch provide the patient with additional sources of information, draw their attention to the topics being discussed, and refocus them. In addition, Memory Therapy is a good method for recalling memories and movements that are not readily available or otherwise inaccessible.
The study will be conducted with elderly individuals who have applied to community health centers based in Kahramanmaraş or to the neurology and psychiatry departments of tertiary hospitals. The sample size of 573 was determined based on data obtained from outpatient clinics and community health units (diagnosis sites). At least 114 participants must be reached. Data collection will utilize the Demographic Information Form, Standardized Mini Mental Test (SMMT), Psychological Flexibility Scale, and Cognitive Flexibility Scale. The data will be collected by the researcher in two stages, pre-test and post-test, from all elderly individuals through face-to-face interviews. The elderly in the intervention group will undergo 10 sessions of Memory Therapy, twice a week for five weeks. The sessions will be planned to last an average of 45 minutes. During the 10 sessions of Memory-Based Recall Therapy applied to the intervention group, memory-enhancing phenomena will be used, and verbal reminders will be provided during repeated narratives.
- Conditions
- Dementia, Memory, Short-Term
- Being tested
- Experimental: Memory Therapy Group
- Keywords
- Memory therapy, memory, cognitive state, psychological flexibility, cognitive flexibility
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Memory Therapy GroupBehavioural
Evaluation of the Effect of Memory-Based Recall Therapy on the Cognitive Status, Psychological Flexibility, and Cognitive Flexibility of Elderly Individuals Diagnosed with Dementia
| Study group | Role | What they receive |
|---|---|---|
| Memory Therapy Group | Experimental | The intervention group of elderly individuals underwent 10 sessions of Memory Therapy, with two sessions per week over a period of five weeks. The sessions were planned to last an average of 45 minutes. During the 10 sessions, Memory-Based Reminiscence Therapy was applied to the intervention group using reminiscence phenomena and verbal reminders were provided in repetitive narratives. Receives: Behavioral: Experimental: Memory Therapy Group |
| Control group | No intervention | No intervention was made for individuals in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
The original Mini Mental Test developed by Folstein et al. (1975) and the standardized version created by Molloy and Standish (1997) are easy to administer and provide information about the degree of cognitive impairment. The lowest possible score on the scale is "0," and the highest possible score is "30." Based on the scores obtained, 0-12 points indicate "severe" cognitive impairment, 13-22 points indicate "moderate" cognitive impairment, 23-24 points indicate 'mild' cognitive impairment, and 25-30 points indicate "no cognitive impairment."
Measured: 0 weeks
Standardized Mini Mental Test
The original Mini Mental Test developed by Folstein et al. (1975) and the standardized version created by Molloy and Standish (1997) are easy to administer and provide information about the degree of cognitive impairment. The lowest possible score on the scale is "0," and the highest possible score is "30." Based on the scores obtained, 0-12 points indicate "severe" cognitive impairment, 13-22 points indicate "moderate" cognitive impairment, 23-24 points indicate 'mild' cognitive impairment, and 25-30 points indicate "no cognitive impairment."
Measured: 5 weeks
Psychological Flexibility Scale
The scale developed by Francis et al. in 2016 was translated into Turkish by Karakuş and Akbay (2020) and underwent validity and reliability testing. The scale consists of 28 items and is a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The Cronbach's alpha value for the total scale in the Turkish validity and reliability study was 0.79, 0.84 for the values and values-based behavior subscale, 0.60 for the "being in the moment" subscale, 0.72 for the 'acceptance' subscale, 0.73 for the "contextual self" subscale, and 0.59 for the "separation" subscale.
Measured: 0 weeks
Psychological Flexibility Scale
The scale developed by Francis et al. in 2016 was translated into Turkish by Karakuş and Akbay (2020) and underwent validity and reliability testing. The scale consists of 28 items and is a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The Cronbach's alpha value for the total scale in the Turkish validity and reliability study was 0.79, 0.84 for the values and values-based behavior subscale, 0.60 for the "being in the moment" subscale, 0.72 for the 'acceptance' subscale, 0.73 for the "contextual self" subscale, and 0.59 for the "separation" subscale.
Measured: 5 weeks
Cognitive Flexibility Inventory
Cognitive Flexibility Inventory (CFI) The Cognitive Flexibility Inventory (CFI) is a short self-report scale developed to measure cognitive flexibility, which is necessary for individuals to adapt to changing environmental stimuli and replace maladaptive thoughts with more balanced and adaptive ones. The scale yields three distinct types of scores: a total cognitive flexibility score, an "alternatives" subscale score, and a "control" subscale score. Higher scores indicate greater cognitive flexibility. The Cronbach's alpha coefficient for the entire scale was found to be .90.
Measured: 0 weeks
Cognitive Flexibility Inventory
Cognitive Flexibility Inventory (CFI) The Cognitive Flexibility Inventory (CFI) is a short self-report scale developed to measure cognitive flexibility, which is necessary for individuals to adapt to changing environmental stimuli and replace maladaptive thoughts with more balanced and adaptive ones. The scale yields three distinct types of scores: a total cognitive flexibility score, an "alternatives" subscale score, and a "control" subscale score. Higher scores indicate greater cognitive flexibility. The Cronbach's alpha coefficient for the entire scale was found to be .90.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start15 Jun 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaraş İstiklal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Harmanci, Kahramanmaraş İstiklal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073443
- Sponsor's protocol ID
- IstiklalU-Harmanci-002
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Memory-based Reminiscence Therapy on Cognitive Status, Psychological Flexibility and Cognitive Flexibility in Older People With Dementia
- ClinicalTrials.gov ID
- NCT07073443
- Acronym / sponsor ID
- IstiklalU-Harmanci-002
- Conditions
- Dementia, Memory, Short-Term
- Keywords
- Memory therapy, memory, cognitive state, psychological flexibility, cognitive flexibility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kahramanmaraş İstiklal UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 18 Jul 2025 (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.
The main objective of this study is to examine the effects of memory-based recall therapy applied to elderly adults diagnosed with Stage 0, 1, and 2 dementia on their mental state, psychological flexibility, and cognitive flexibility.
The original flow plan created in the study is not found in the literature. Therefore, presenting the effects of memory-based recall on cognition in the literature may demonstrate that the contents of classical recall therapy can also be effectively restructured with cognitive effects. From this perspective, the aim is to make recommendations for "advanced psychiatric nursing practices."
Research Hypotheses:
H0: Memory-based recall therapy has no effect on mental state, psychological flexibility, and cognitive flexibility in individuals with early-stage dementia.
H1: Memory-based Recall Therapy has an effect on mental state, psychological flexibility, and cognitive flexibility in individuals with early-stage dementia.
Detailed description
Memory therapy is very important for elderly people with declining cognitive functions, as it can stimulate various senses such as touch, taste, and smell. Materials that facilitate recall can be used in therapy. Physical objects that the elderly can look at and touch provide the patient with additional sources of information, draw their attention to the topics being discussed, and refocus them. In addition, Memory Therapy is a good method for recalling memories and movements that are not readily available or otherwise inaccessible.
The study will be conducted with elderly individuals who have applied to community health centers based in Kahramanmaraş or to the neurology and psychiatry departments of tertiary hospitals. The sample size of 573 was determined based on data obtained from outpatient clinics and community health units (diagnosis sites). At least 114 participants must be reached. Data collection will utilize the Demographic Information Form, Standardized Mini Mental Test (SMMT), Psychological Flexibility Scale, and Cognitive Flexibility Scale. The data will be collected by the researcher in two stages, pre-test and post-test, from all elderly individuals through face-to-face interviews. The elderly in the intervention group will undergo 10 sessions of Memory Therapy, twice a week for five weeks. The sessions will be planned to last an average of 45 minutes. During the 10 sessions of Memory-Based Recall Therapy applied to the intervention group, memory-enhancing phenomena will be used, and verbal reminders will be provided during repeated narratives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory Therapy Group | Experimental | Behavioral: Experimental: Memory Therapy GroupThe intervention group of elderly individuals underwent 10 sessions of Memory Therapy, with two sessions per week over a period of five weeks. The sessions were planned to last an average of 45 minutes. During the 10 sessions, Memory-Based Reminiscence Therapy was applied to the intervention group using reminiscence phenomena and verbal reminders were provided in repetitive narratives. |
| Control group | No intervention | –No intervention was made for individuals in this group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Receiving outpatient treatment for dementia from the relevant departments of hospitals
- At the time of the interviews, the doctor must have diagnosed mild dementia. (Stages 0, 1, and 2)
- No problems with understanding or speaking Turkish
- Being literate
- Being in the 65 and older age group
Key exclusion criteria (4 listed)
- Not having been diagnosed with dementia during the study
- Having other chronic cognitive and psychiatric illnesses
- Being in an advanced stage of dementia
- Those who withdrew from the study during the interview or refused to participate in the study
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 |
|---|---|---|
| Experimental: Memory Therapy GroupEvaluation of the Effect of Memory-Based Recall Therapy on the Cognitive Status, Psychological Flexibility, and Cognitive Flexibility of Elderly Individuals Diagnosed with Dementia | Behavioural | Memory Therapy Group |
Primary outcome
Standardized Mini Mental Test
Time frame: 0 weeks
The original Mini Mental Test developed by Folstein et al. (1975) and the standardized version created by Molloy and Standish (1997) are easy to administer and provide information about the degree of cognitive impairment. The lowest possible score on the scale is "0," and the highest possible score is "30." Based on the scores obtained, 0-12 points indicate "severe" cognitive impairment, 13-22 points indicate "moderate" cognitive impairment, 23-24 points indicate 'mild' cognitive impairment, and 25-30 points indicate "no cognitive impairment."
Standardized Mini Mental Test
Time frame: 5 weeks
The original Mini Mental Test developed by Folstein et al. (1975) and the standardized version created by Molloy and Standish (1997) are easy to administer and provide information about the degree of cognitive impairment. The lowest possible score on the scale is "0," and the highest possible score is "30." Based on the scores obtained, 0-12 points indicate "severe" cognitive impairment, 13-22 points indicate "moderate" cognitive impairment, 23-24 points indicate 'mild' cognitive impairment, and 25-30 points indicate "no cognitive impairment."
Psychological Flexibility Scale
Time frame: 0 weeks
The scale developed by Francis et al. in 2016 was translated into Turkish by Karakuş and Akbay (2020) and underwent validity and reliability testing. The scale consists of 28 items and is a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The Cronbach's alpha value for the total scale in the Turkish validity and reliability study was 0.79, 0.84 for the values and values-based behavior subscale, 0.60 for the "being in the moment" subscale, 0.72 for the 'acceptance' subscale, 0.73 for the "contextual self" subscale, and 0.59 for the "separation" subscale.
Psychological Flexibility Scale
Time frame: 5 weeks
The scale developed by Francis et al. in 2016 was translated into Turkish by Karakuş and Akbay (2020) and underwent validity and reliability testing. The scale consists of 28 items and is a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The Cronbach's alpha value for the total scale in the Turkish validity and reliability study was 0.79, 0.84 for the values and values-based behavior subscale, 0.60 for the "being in the moment" subscale, 0.72 for the 'acceptance' subscale, 0.73 for the "contextual self" subscale, and 0.59 for the "separation" subscale.
Cognitive Flexibility Inventory
Time frame: 0 weeks
Cognitive Flexibility Inventory (CFI) The Cognitive Flexibility Inventory (CFI) is a short self-report scale developed to measure cognitive flexibility, which is necessary for individuals to adapt to changing environmental stimuli and replace maladaptive thoughts with more balanced and adaptive ones. The scale yields three distinct types of scores: a total cognitive flexibility score, an "alternatives" subscale score, and a "control" subscale score. Higher scores indicate greater cognitive flexibility. The Cronbach's alpha coefficient for the entire scale was found to be .90.
Cognitive Flexibility Inventory
Time frame: 5 weeks
Cognitive Flexibility Inventory (CFI) The Cognitive Flexibility Inventory (CFI) is a short self-report scale developed to measure cognitive flexibility, which is necessary for individuals to adapt to changing environmental stimuli and replace maladaptive thoughts with more balanced and adaptive ones. The scale yields three distinct types of scores: a total cognitive flexibility score, an "alternatives" subscale score, and a "control" subscale score. Higher scores indicate greater cognitive flexibility. The Cronbach's alpha coefficient for the entire scale was found to be .90.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Memory Therapy Group in people with Dementia and Memory, Short-Term, run by Kahramanmaraş İstiklal 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 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Standardized Mini Mental Test (time frame: 0 weeks). The study lists 6 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 18 Jul 2025.