Alzheimer DiseaseNCT06666075
Digital Reminiscence Therapy for Alzheimer's in Institutionalized People
A study testing Digital and Interactive Reminiscence in people with Alzheimer Disease, run by University of Jaén at 1 site in Spain.
Trial summary
Digital reminiscence therapy (DRT) is an innovative intervention designed to enhance the psychological health of institutionalized seniors with Alzheimer's disease. This approach utilizes digital tools to facilitate the sharing of personal memories and experiences, fostering social interaction and emotional… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Digital and Interactive Reminiscence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2025to 18 Apr 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over 60 years of age.
- Confirmed diagnosis of mild or moderate Alzheimer's, where the patient still retains a certain degree of autobiographical memory.
- People institutionalized in a geriatric care center or similar.
- Level of cognitive impairment that allows understanding and basic interaction with digital tools.
- Approval and signature of informed consent by the participant or his/her legal representative, demonstrating agreement to participate in the study.
- Availability or access to devices (tablets or computers) provided by the study program or the care center.
Who cannot join
- Diagnosis of other neurological or psychiatric conditions (such as vascular dementia, Parkinson's, or psychotic disorders) that may significantly interfere with the program's results.
- Patients in advanced stages of Alzheimer's with severe limitations in remembering autobiographical events or interacting with digital devices.
- Vision, hearing, or fine motor problems that prevent the use of electronic devices in an appropriate manner, without the possibility of adaptation or assistance.
- Individuals or legal representatives who are unable or unwilling to give informed consent.
- Behaviors that may put the participant, staff, or other residents at risk when carrying out program activities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological and Mental Health of Institutionalized People Over 60 Years of Age With Alzheimer's: Effects of a Digital and Interactive Reminiscence Program.
Digital reminiscence therapy (DRT) is an innovative intervention designed to enhance the psychological health of institutionalized seniors with Alzheimer's disease. This approach utilizes digital tools to facilitate the sharing of personal memories and experiences, fostering social interaction and emotional engagement. By combining technology with therapeutic reminiscence techniques, DRT aims to stimulate cognitive function and improve mood, potentially alleviating symptoms of anxiety and depression commonly observed in this population.
Research indicates that reminiscence therapy can lead to improvements in quality of life and overall well-being for individuals with dementia. The interactive nature of digital platforms encourages participation and allows caregivers to customize content based on the individual's preferences and history. As such, DRT not only serves to strengthen the connections between seniors and their pasts but also enhances their current social interactions, promoting a sense of identity and belonging. Overall, DRT represents a promising avenue for addressing the psychological needs of older adults with Alzheimer's in institutional settings, highlighting the potential benefits of integrating technology into therapeutic practices.
- Conditions
- Alzheimer Disease
- Being tested
- Digital and Interactive Reminiscence
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital and Interactive ReminiscenceOther
The intervention for the experimental group aims to enhance the psychological well-being of institutionalized seniors with Alzheimer's through a digital and interactive reminiscence therapy program. It begins with selecting participants based on specific inclusion and exclusion criteria, followed by developing personalized digital profiles that include photographs, music, videos, and life anecdotes to evoke emotional memories. Care staff receive training in using the digital software and reminiscence techniques. The core intervention consists of digital reminiscence sessions held twice a week for eight weeks, lasting about 60 minutes each, featuring multimedia content to encourage discussion and memory sharing. Interactive activities foster active participation, with facilitators promoting emotional expression and connection among participants, creating a supportive environment that stimulates cognitive function and reduces isolation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will not participate in the physical or cognitive exercise intervention but will receive general recommendations for comprehensive health care. This includes discussions about the benefits of engaging in physical and cognitive exercise, as well as advice on managing physical and mental health. All proposed physical and mental assessments will be conducted with the control group at the beginning of the study and after 12 weeks. Additionally, during the study period, they will be monitored for any changes in physical activity levels that may occur throughout the intervention. Follow-up will also include tracking nutritional changes, sleep habits, and stress levels. |
| Experimental Group | Experimental | The intervention for the experimental group implements a digital and interactive reminiscence program, starting with a preparation phase to select participants based on predefined criteria. Personalized content is developed for each individual, creating digital profiles that include photographs, music, videos, and significant life anecdotes tailored to evoke emotional memories. Care staff receive training on using the software and reminiscence techniques to facilitate the intervention. The implementation phase includes group and individual digital reminiscence sessions held twice a week for eight weeks, lasting about 60 minutes each. These sessions present selected digital content to promote discussion and memory sharing. Interactive activities, such as games and exercises, foster active participation, while the facilitator encourages participants to share stories and emotions, creating a supportive environment. Receives: Other: Digital and Interactive Reminiscence |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Life in Alzheimer's Disease (QoL-AD)
This Scale is a 13-item tool that measures quality of life specifically in people with Alzheimer's. Each item is scored from 1 to 4, with a higher score indicating a better perception of quality of life. Areas assessed include mood, physical well-being, relationships, and environment. A high total score suggests a positive perception of quality of life, useful for assessing the impact of psychological and therapeutic interventions.
Measured: Up to twelve weeks
Mini-Mental State Examination (MMSE)
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Measured: Up to twelve weeks
Montreal Cognitive Assessment (MoCA)
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Measured: Up to twelve weeks
Trail Making Test (TMT)
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Measured: Up to twelve weeks
Isaacs test
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Measured: Up to twelve weeks
Hospital Anxiety and Depression Scale (HADS)
Assesses symptoms of anxiety (HADS-A) and depression (HADS-D) using 14 items (7 for each subscale), each scored from 0 to 3. Scores range from 0 to 21 for anxiety and for depression, where 0-7 is normal, 8-10 indicates possible symptoms, and 11 or higher suggests a clinical disorder. The HADS is ideal for identifying emotional symptoms in patients with mild to moderate cognitive impairment, complementing the MMSE for a comprehensive assessment of mental and emotional status.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Jan 2025
- Primary completion14 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666075
- Sponsor's protocol ID
- -UJAEN-
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Mental Health of Institutionalized People Over 60 Years of Age With Alzheimer's: Effects of a Digital and Interactive Reminiscence Program.
- ClinicalTrials.gov ID
- NCT06666075
- Acronym / sponsor ID
- -UJAEN-
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 30 Oct 2024 (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.
Digital reminiscence therapy (DRT) is an innovative intervention designed to enhance the psychological health of institutionalized seniors with Alzheimer's disease. This approach utilizes digital tools to facilitate the sharing of personal memories and experiences, fostering social interaction and emotional engagement. By combining technology with therapeutic reminiscence techniques, DRT aims to stimulate cognitive function and improve mood, potentially alleviating symptoms of anxiety and depression commonly observed in this population.
Research indicates that reminiscence therapy can lead to improvements in quality of life and overall well-being for individuals with dementia. The interactive nature of digital platforms encourages participation and allows caregivers to customize content based on the individual's preferences and history. As such, DRT not only serves to strengthen the connections between seniors and their pasts but also enhances their current social interactions, promoting a sense of identity and belonging. Overall, DRT represents a promising avenue for addressing the psychological needs of older adults with Alzheimer's in institutional settings, highlighting the potential benefits of integrating technology into therapeutic practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will not participate in the physical or cognitive exercise intervention but will receive general recommendations for comprehensive health care. This includes discussions about the benefits of engaging in physical and cognitive exercise, as well as advice on managing physical and mental health. All proposed physical and mental assessments will be conducted with the control group at the beginning of the study and after 12 weeks. Additionally, during the study period, they will be monitored for any changes in physical activity levels that may occur throughout the intervention. Follow-up will also include tracking nutritional changes, sleep habits, and stress levels. |
| Experimental Group | Experimental | Other: Digital and Interactive ReminiscenceThe intervention for the experimental group implements a digital and interactive reminiscence program, starting with a preparation phase to select participants based on predefined criteria. Personalized content is developed for each individual, creating digital profiles that include photographs, music, videos, and significant life anecdotes tailored to evoke emotional memories. Care staff receive training on using the software and reminiscence techniques to facilitate the intervention. The implementation phase includes group and individual digital reminiscence sessions held twice a week for eight weeks, lasting about 60 minutes each. These sessions present selected digital content to promote discussion and memory sharing. Interactive activities, such as games and exercises, foster active participation, while the facilitator encourages participants to share stories and emotions, creating a supportive environment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People over 60 years of age.
- Confirmed diagnosis of mild or moderate Alzheimer's, where the patient still retains a certain degree of autobiographical memory.
- People institutionalized in a geriatric care center or similar.
- Level of cognitive impairment that allows understanding and basic interaction with digital tools.
- Approval and signature of informed consent by the participant or his/her legal representative, demonstrating agreement to participate in the study.
Key exclusion criteria (5 listed)
- Diagnosis of other neurological or psychiatric conditions (such as vascular dementia, Parkinson's, or psychotic disorders) that may significantly interfere with the program's results.
- Patients in advanced stages of Alzheimer's with severe limitations in remembering autobiographical events or interacting with digital devices.
- Vision, hearing, or fine motor problems that prevent the use of electronic devices in an appropriate manner, without the possibility of adaptation or assistance.
- Individuals or legal representatives who are unable or unwilling to give informed consent.
- Behaviors that may put the participant, staff, or other residents at risk when carrying out program activities.
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 |
|---|---|---|
| Digital and Interactive ReminiscenceThe intervention for the experimental group aims to enhance the psychological well-being of institutionalized seniors with Alzheimer's through a digital and interactive reminiscence therapy program. It begins with selecting participants based on specific inclusion and exclusion criteria, followed by developing personalized digital profiles that include photographs, music, videos, and life anecdotes to evoke emotional memories. Care staff receive training in using the digital software and reminiscence techniques. The core intervention consists of digital reminiscence sessions held twice a week for eight weeks, lasting about 60 minutes each, featuring multimedia content to encourage discussion and memory sharing. Interactive activities foster active participation, with facilitators promoting emotional expression and connection among participants, creating a supportive environment that stimulates cognitive function and reduces isolation. | Other | Experimental Group |
Primary outcome
The Quality of Life in Alzheimer's Disease (QoL-AD)
Time frame: Up to twelve weeks
This Scale is a 13-item tool that measures quality of life specifically in people with Alzheimer's. Each item is scored from 1 to 4, with a higher score indicating a better perception of quality of life. Areas assessed include mood, physical well-being, relationships, and environment. A high total score suggests a positive perception of quality of life, useful for assessing the impact of psychological and therapeutic interventions.
Mini-Mental State Examination (MMSE)
Time frame: Up to twelve weeks
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Montreal Cognitive Assessment (MoCA)
Time frame: Up to twelve weeks
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Trail Making Test (TMT)
Time frame: Up to twelve weeks
It is used to assess executive function. It measures timed motor and visual tasks, and is divided into two tests: Part A (TMTA), which assesses speed and psychomotor attention and requires connecting consecutively numbered circles; and Part B (TMTB), which tests executive function and requires connecting alternating circles of numbers and letters. Longer completion times indicate poor performance.
Isaacs test
Time frame: Up to twelve weeks
Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.Instrument used to assess verbal fluency. Participants have 60 seconds to generate as many words as possible within a given semantic category (animals, colors, fruits, and cities). The maximum score is 40 points (with a maximum of 10 per category). The higher the score, the better the level of verbal fluency.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to twelve weeks
Assesses symptoms of anxiety (HADS-A) and depression (HADS-D) using 14 items (7 for each subscale), each scored from 0 to 3. Scores range from 0 to 21 for anxiety and for depression, where 0-7 is normal, 8-10 indicates possible symptoms, and 11 or higher suggests a clinical disorder. The HADS is ideal for identifying emotional symptoms in patients with mild to moderate cognitive impairment, complementing the MMSE for a comprehensive assessment of mental and emotional status.
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 15 Aug 2025.
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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 Digital and Interactive Reminiscence in people with Alzheimer Disease, run by University of Jaén at 1 site in Spain.
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 5 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 15 Aug 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 Spain. 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?
The Quality of Life in Alzheimer's Disease (QoL-AD) (time frame: Up to twelve 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 15 Aug 2025.