NCT06666075

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

October 28, 2024

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Up to twelve weeks

Study Arms (2)

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.

Other: Digital and Interactive Reminiscence

Interventions

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.

Experimental Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Ángel Fernández Sevilla

Jaén, 23007, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

January 20, 2025

Primary Completion

April 14, 2025

Study Completion

April 18, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations