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Completed

NCT Number: NCT07825909

Virtual Reality-Assisted Reminiscence Therapy in Older Adults With Cognitive Impairment

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Diurno Casetta Michelino, Padova, Padova/Veneto, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Virtual Reality-Assisted Reminiscence Therapy

Behavioral

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.

Other names: RT+VR

Traditional Reminiscence Therapy

Behavioral

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.

Other names: RT

Primary outcomes

  1. Change in Global Cognitive Functioning Assessed With the MMSE-2

    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, Second Edition (MMSE-2). Total scores were adjusted for age and/or educational level according to the correction procedures specified in the test manual. Higher scores indicate better global cognitive functioning. Change from baseline to post-intervention was compared across the three study groups.

  2. Change in Depressive Symptoms Assessed With the Geriatric Depression Scale

    Time frame: Baseline and post-intervention, after completion of the 12-session intervention period (approximately 6 weeks)

    Depressive symptoms were assessed using the Geriatric Depression Scale (GDS). Higher scores indicate greater depressive symptom severity. Change from baseline to post-intervention was compared across the three study groups.

  3. Change in Neuropsychiatric Symptoms Assessed With the Neuropsychiatric Inventory

    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). Symptom severity was evaluated using frequency-by-severity scores (frequency × severity) for the assessed neuropsychiatric domains. NPI-derived symptom composite scores were also examined. Higher scores indicate greater neuropsychiatric symptom burden. Change from baseline to post-intervention was compared across the three study groups.

  4. Change in Health-Related Quality of Life Assessed With the 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) across its health domains. For most domains, higher scores indicate better perceived health or functioning. Role Physical and Role Emotional were scored as limitation measures in this study, with higher scores indicating greater limitations. Change from baseline to post-intervention was compared across the three study groups.

Sponsors and collaborators

Lead sponsor

Istituto Universitario Salesiano Venezia-Mestre (IUS)

Other

Registry information

Official study title

L'Impatto Della Realtà Virtuale Nella Terapia Della Reminiscenza: Al di là Del Tempo, un Ponte Tra Passato e Presente Nel Paziente Anziano

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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