Cognitive ImpairmentNCT07825909
Virtual Reality-Assisted Reminiscence Therapy in Older Adults With Cognitive Impairment
A study testing Virtual Reality-Assisted Reminiscence Therapy and Traditional Reminiscence Therapy in people with Cognitive Impairment, run by Istituto Universitario Salesiano Venezia-Mestre (IUS) at 2 sites in Italy.
Trial summary
This study evaluated whether immersive virtual reality (VR) could enhance the effects of reminiscence therapy in older adults with cognitive impairment attending day-care services. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Virtual Reality-Assisted Reminiscence Therapy and Traditional Reminiscence Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Apr 2024to 21 Dec 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
- No healthy volunteers
- Older adult
Who may be able to join
- Older adults attending one of the participating day-care centres.
- Presence of mild-to-moderate cognitive impairment, as determined by the study's cognitive screening criteria.
- Ability to participate in the study procedures and reminiscence therapy sessions.
- Provision of written informed consent by the participant and/or, where required, by a legal representative.
Who cannot join
- Severe or very severe cognitive impairment below the MMSE eligibility threshold.
- Major visual impairment incompatible with the use of immersive virtual reality or study procedures.
- Absence of informed consent from the participant and/or legal representative where required.
- Clinical or functional conditions preventing safe participation in the intervention or completion of study procedures.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Centro Diurno Casetta Michelino
Padova, Padova/Veneto, 35133
Centro Diurno FAI Padova
Padova, Padova/Veneto, 35141
About this study
Official title: L'Impatto Della Realtà Virtuale Nella Terapia Della Reminiscenza: Al di là Del Tempo, un Ponte Tra Passato e Presente Nel Paziente Anziano
This study evaluated whether immersive virtual reality (VR) could enhance the effects of reminiscence therapy in older adults with cognitive impairment attending day-care services. Participants were assigned to one of three conditions: individual reminiscence therapy supported by immersive VR (RT+VR), individual traditional reminiscence therapy without VR, or usual care. The study examined changes in cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. The aim was to determine whether adding an immersive and personalized virtual environment to reminiscence therapy could provide additional benefits compared with traditional reminiscence therapy and usual care.
Read the detailed description
This was a pragmatic, three-arm randomized interventional study conducted in two day-care centres for older adults in North-East Italy. The study investigated the effects of immersive virtual reality-assisted reminiscence therapy (RT+VR) in older adults with mild-to-moderate cognitive impairment.
Participants were randomly assigned to one of three conditions: (1) individual reminiscence therapy supported by immersive VR; (2) individual traditional reminiscence therapy without VR; or (3) usual care consisting of the routine activities provided by the day-care centres without structured reminiscence therapy or VR.
In the RT+VR condition, reminiscence therapy was supported by immersive environments presented through a head-mounted VR display. Virtual scenarios were used as contextual cues to facilitate the retrieval and narration of autobiographical memories. The traditional reminiscence therapy condition followed comparable therapeutic principles and was delivered individually without immersive technology, using conventional reminiscence materials and conversational prompts.
Outcomes were assessed at baseline and after completion of the intervention period. Assessments included measures of cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. Additional neuropsychological measures were used to assess selected cognitive functions. Outcome assessments were conducted by psychologists who were not involved in intervention delivery and were blinded to group allocation.
The study was designed to examine whether the addition of immersive VR to reminiscence therapy was associated with greater changes in psychological and cognitive outcomes than traditional reminiscence therapy and usual care.
- Conditions
- Cognitive Impairment
- Being tested
- Virtual Reality-Assisted Reminiscence Therapy, Traditional Reminiscence Therapy
- Keywords
- Reminiscence Therapy, Virtual Reality, Older Adults, Cognitive Impairment, Non-Pharmacological Intervention, Health-Related Quality of Life
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Assisted Reminiscence TherapyBehavioural
Also called RT+VR
Individual reminiscence therapy supported by immersive virtual reality was delivered in 12 sessions, twice weekly, lasting approximately 35 minutes each. Participants remained seated and experienced immersive virtual environments through a Meta Quest 3 head-mounted display. The virtual environments provided contextual and autobiographical cues to facilitate the retrieval and narration of personal memories. Scenario selection and switching were managed by an external operator to reduce cognitive and operational demands on participants. Sessions were conducted by trained psychologists.
Traditional Reminiscence TherapyBehavioural
Also called RT
Individual traditional reminiscence therapy was delivered in 12 sessions, twice weekly, lasting approximately 35 minutes each. Trained psychologists facilitated the retrieval and narration of autobiographical memories using conventional reminiscence cues, including photographs, objects, and guided discussion of personally meaningful memories. The intervention was delivered without immersive virtual reality and was matched to the VR-assisted reminiscence therapy condition in number, frequency, and approximate duration of sessions.
| Study group | Role | What they receive |
|---|---|---|
| VR-Assisted Reminiscence Therapy (RT+VR) | Experimental | Participants received individual reminiscence therapy supported by immersive virtual reality. The intervention comprised 12 individual sessions, delivered twice weekly and lasting approximately 35 minutes each. Immersive virtual environments were used as contextual and autobiographical cues to facilitate reminiscence. Participants remained seated during VR exposure, and virtual scenarios were managed by an external operator to minimize cognitive and operational demands. Receives: Behavioral: Virtual Reality-Assisted Reminiscence Therapy |
| Traditional Reminiscence Therapy (RT) | Active comparator | Participants received individual traditional reminiscence therapy without virtual reality. The intervention was dose-matched to the RT+VR condition, with 12 individual sessions delivered twice weekly and lasting approximately 35 minutes each. Reminiscence was facilitated using conventional autobiographical cues, including photographs, objects, and guided discussion of personal memories. Receives: Behavioral: Traditional Reminiscence Therapy |
| Usual Care | No intervention | Participants continued the routine activities provided by their day-care centre and did not receive structured reminiscence therapy or virtual reality as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Cognitive Functioning Assessed With the Mini-Mental State Examination (MMSE)
Global cognitive functioning was assessed using the Mini-Mental State Examination (MMSE). Total scores range from 0 to 30, with higher scores indicating better global cognitive functioning. Total scores were adjusted for age and/or educational level according to the correction procedures used in the study. Change from baseline to post-intervention was compared across the three study groups.
Measured: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks).
Change in Depressive Symptoms Assessed With the 15-Item Geriatric Depression Scale (GDS-15)
Depressive symptoms were assessed using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating greater depressive symptom severity and therefore a worse outcome. Change from baseline to post-intervention was compared across the three study groups.
Measured: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Change in Neuropsychiatric Symptoms Assessed With the Neuropsychiatric Inventory (NPI)
Neuropsychiatric symptoms were assessed using the Neuropsychiatric Inventory (NPI). For each assessed domain, frequency is multiplied by severity to obtain a domain score ranging from 0 to 12, with higher scores indicating greater neuropsychiatric symptom burden and therefore a worse outcome. Study-derived symptom composite scores were calculated as the mean of the relevant domain scores and therefore also range from 0 to 12, with higher scores indicating greater symptom burden. Change from baseline to post-intervention was compared across the three study groups.
Measured: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Change in Health-Related Quality of Life Assessed With the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). Each domain score ranges from 0 to 100. For most domains, higher scores indicate better perceived health or functioning. In this study, Role Physical and Role Emotional were retained as limitation scores, for which higher scores indicate greater limitation and therefore a worse outcome. Change from baseline to post-intervention was compared across the three study groups.
Measured: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start7 Apr 2024
- Primary completion22 Jul 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Model description
- Participants were assigned to one of three parallel study arms: VR-assisted reminiscence therapy, traditional reminiscence therapy, or usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Universitario Salesiano Venezia-Mestre (IUS)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Maria Marchioro, Istituto Universitario Salesiano Venezia-Mestre (IUS)
- Investigators
- DAVIDE MARIA MARCHIORO, PhD, Study director, IUS - ISTITUTO UNIVERSITARIO SALESIANO VENEZIA-MESTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825909
- Sponsor's protocol ID
- IUSVE-EC-2023-002
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request, subject to applicable ethical, privacy, and data-protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Impatto Della Realtà Virtuale Nella Terapia Della Reminiscenza: Al di là Del Tempo, un Ponte Tra Passato e Presente Nel Paziente Anziano
- ClinicalTrials.gov ID
- NCT07825909
- Acronym / sponsor ID
- IUSVE-EC-2023-002
- Conditions
- Cognitive Impairment
- Keywords
- Reminiscence Therapy, Virtual Reality, Older Adults, Cognitive Impairment, Non-Pharmacological Intervention, Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Universitario Salesiano Venezia-Mestre (IUS)University, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 17 Sep 2026 (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 study evaluated whether immersive virtual reality (VR) could enhance the effects of reminiscence therapy in older adults with cognitive impairment attending day-care services. Participants were assigned to one of three conditions: individual reminiscence therapy supported by immersive VR (RT+VR), individual traditional reminiscence therapy without VR, or usual care. The study examined changes in cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. The aim was to determine whether adding an immersive and personalized virtual environment to reminiscence therapy could provide additional benefits compared with traditional reminiscence therapy and usual care.
Detailed description
This was a pragmatic, three-arm randomized interventional study conducted in two day-care centres for older adults in North-East Italy. The study investigated the effects of immersive virtual reality-assisted reminiscence therapy (RT+VR) in older adults with mild-to-moderate cognitive impairment.
Participants were randomly assigned to one of three conditions: (1) individual reminiscence therapy supported by immersive VR; (2) individual traditional reminiscence therapy without VR; or (3) usual care consisting of the routine activities provided by the day-care centres without structured reminiscence therapy or VR.
In the RT+VR condition, reminiscence therapy was supported by immersive environments presented through a head-mounted VR display. Virtual scenarios were used as contextual cues to facilitate the retrieval and narration of autobiographical memories. The traditional reminiscence therapy condition followed comparable therapeutic principles and was delivered individually without immersive technology, using conventional reminiscence materials and conversational prompts.
Outcomes were assessed at baseline and after completion of the intervention period. Assessments included measures of cognitive functioning, depressive symptoms, neuropsychiatric symptoms, and health-related quality of life. Additional neuropsychological measures were used to assess selected cognitive functions. Outcome assessments were conducted by psychologists who were not involved in intervention delivery and were blinded to group allocation.
The study was designed to examine whether the addition of immersive VR to reminiscence therapy was associated with greater changes in psychological and cognitive outcomes than traditional reminiscence therapy and usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were assigned to one of three parallel study arms: VR-assisted reminiscence therapy, traditional reminiscence therapy, or usual care.
| Arm | Type | Receives |
|---|---|---|
| VR-Assisted Reminiscence Therapy (RT+VR) | Experimental | Behavioral: Virtual Reality-Assisted Reminiscence TherapyParticipants received individual reminiscence therapy supported by immersive virtual reality. The intervention comprised 12 individual sessions, delivered twice weekly and lasting approximately 35 minutes each. Immersive virtual environments were used as contextual and autobiographical cues to facilitate reminiscence. Participants remained seated during VR exposure, and virtual scenarios were managed by an external operator to minimize cognitive and operational demands. |
| Traditional Reminiscence Therapy (RT) | Active comparator | Behavioral: Traditional Reminiscence TherapyParticipants received individual traditional reminiscence therapy without virtual reality. The intervention was dose-matched to the RT+VR condition, with 12 individual sessions delivered twice weekly and lasting approximately 35 minutes each. Reminiscence was facilitated using conventional autobiographical cues, including photographs, objects, and guided discussion of personal memories. |
| Usual Care | No intervention | –Participants continued the routine activities provided by their day-care centre and did not receive structured reminiscence therapy or virtual reality as part of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Older adults attending one of the participating day-care centres.
- Presence of mild-to-moderate cognitive impairment, as determined by the study's cognitive screening criteria.
- Ability to participate in the study procedures and reminiscence therapy sessions.
- Provision of written informed consent by the participant and/or, where required, by a legal representative.
Key exclusion criteria (4 listed)
- Severe or very severe cognitive impairment below the MMSE eligibility threshold.
- Major visual impairment incompatible with the use of immersive virtual reality or study procedures.
- Absence of informed consent from the participant and/or legal representative where required.
- Clinical or functional conditions preventing safe participation in the intervention or completion of study procedures.
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 |
|---|---|---|
| Virtual Reality-Assisted Reminiscence TherapyAlso: RT+VRIndividual reminiscence therapy supported by immersive virtual reality was delivered in 12 sessions, twice weekly, lasting approximately 35 minutes each. Participants remained seated and experienced immersive virtual environments through a Meta Quest 3 head-mounted display. The virtual environments provided contextual and autobiographical cues to facilitate the retrieval and narration of personal memories. Scenario selection and switching were managed by an external operator to reduce cognitive and operational demands on participants. Sessions were conducted by trained psychologists. | Behavioural | VR-Assisted Reminiscence Therapy (RT+VR) |
| Traditional Reminiscence TherapyAlso: RTIndividual traditional reminiscence therapy was delivered in 12 sessions, twice weekly, lasting approximately 35 minutes each. Trained psychologists facilitated the retrieval and narration of autobiographical memories using conventional reminiscence cues, including photographs, objects, and guided discussion of personally meaningful memories. The intervention was delivered without immersive virtual reality and was matched to the VR-assisted reminiscence therapy condition in number, frequency, and approximate duration of sessions. | Behavioural | Traditional Reminiscence Therapy (RT) |
Primary outcome
Change in Global Cognitive Functioning Assessed With the Mini-Mental State Examination (MMSE)
Time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks).
Global cognitive functioning was assessed using the Mini-Mental State Examination (MMSE). Total scores range from 0 to 30, with higher scores indicating better global cognitive functioning. Total scores were adjusted for age and/or educational level according to the correction procedures used in the study. Change from baseline to post-intervention was compared across the three study groups.
Change in Depressive Symptoms Assessed With the 15-Item Geriatric Depression Scale (GDS-15)
Time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Depressive symptoms were assessed using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating greater depressive symptom severity and therefore a worse outcome. Change from baseline to post-intervention was compared across the three study groups.
Change in Neuropsychiatric Symptoms Assessed With the Neuropsychiatric Inventory (NPI)
Time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Neuropsychiatric symptoms were assessed using the Neuropsychiatric Inventory (NPI). For each assessed domain, frequency is multiplied by severity to obtain a domain score ranging from 0 to 12, with higher scores indicating greater neuropsychiatric symptom burden and therefore a worse outcome. Study-derived symptom composite scores were calculated as the mean of the relevant domain scores and therefore also range from 0 to 12, with higher scores indicating greater symptom burden. Change from baseline to post-intervention was compared across the three study groups.
Change in Health-Related Quality of Life Assessed With the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). Each domain score ranges from 0 to 100. For most domains, higher scores indicate better perceived health or functioning. In this study, Role Physical and Role Emotional were retained as limitation scores, for which higher scores indicate greater limitation and therefore a worse outcome. Change from baseline to post-intervention was compared across the three study groups.
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request, subject to applicable ethical, privacy, and data-protection requirements.
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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.
DAVIDE MARIA MARCHIORO, PhD study director
IUS - ISTITUTO UNIVERSITARIO SALESIANO VENEZIA-MESTRE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Assisted Reminiscence Therapy and Traditional Reminiscence Therapy in people with Cognitive Impairment, run by Istituto Universitario Salesiano Venezia-Mestre (IUS) at 2 sites in Italy.
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 4 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 in Global Cognitive Functioning Assessed With the Mini-Mental State Examination (MMSE) (time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks).). 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 24 Sep 2026.