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

NCT07825909 | Completed

• 1 other identifier: IUSVE-EC-2023-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cognitive Impairment

Keywords

Reminiscence Therapy; Virtual Reality; Older Adults; Cognitive Impairment; Non-Pharmacological Intervention; Health-Related Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Study Arms (3)

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.

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.

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.

Interventions

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.

Also known as: RT+VR

VR-Assisted Reminiscence Therapy (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.

Also known as: RT

Traditional Reminiscence Therapy (RT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Universitario Salesiano Venezia-Mestre (IUS): lead

Study Sites (2)

Centro Diurno Casetta Michelino

Padova, Padova/Veneto, 35133, Italy

Location

Centro Diurno FAI Padova

Padova, Padova/Veneto, 35141, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• DAVIDE MARIA MARCHIORO, PhD

  IUS - ISTITUTO UNIVERSITARIO SALESIANO VENEZIA-MESTRE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were conducted by psychologists who were not involved in intervention delivery and were blinded to participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Psychology Area and Principal Investigator

Model Details: Participants were assigned to one of three parallel study arms: VR-assisted reminiscence therapy, traditional reminiscence therapy, or usual care.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: April 7, 2024
• Primary Completion: July 22, 2024
• Study Completion: December 21, 2024
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available following publication of the study results. No predetermined end date is specified.
• Access Criteria: Data may be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include the purpose of the proposed analysis and will be evaluated in accordance with ethical, privacy, and data-protection requirements.

Locations

IT (2)