REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders (REMINISCENCES)

REMINISCENCES : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders

Presentation & Pre-screening of the control group / reminiscence group Patient/resident pre-screening team meeting for the study Explanation and proposal of the study to patients and their families Signature of resident/patient and family consents Audit of inclusion and non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor) with the patient or resident.

Creation of video contents Creation of personalized video contents Clinical scales review Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general practitioner, geriatrician)

• Pre-test phase with the patient for the use of the VR headset
• Randomisation
• Session procedure As previously mentioned, the virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.

Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).

The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.

The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) with a different virtual environment every 3 weeks.

During the session, note will be taken on the subject's speech. The session will also be filmed and/or recorded with a prior signed agreement by the patient or his representative.

- Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug prescriptions

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Alzheimer Disease; Virtual Reality
• Intervention / Treatment: Procedure: virtual reality session

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier GUERIN, PU-PH; Phone Number: 0492038773; Email: guerin.o@chu-nice.fr
• Study Contact Backup: Name: Anne-Julie VAILLANT-CISZEWICZ, PhD; Phone Number: 0492038773; Email: vaillantciszewicz.a@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice
  • Nice, France
    • EPHAD Ancilla
  • Nice, France
    • EPHAD Clos de Cimiez
  • Nice, France
    • Hopital privé Gériatrique Les Sources

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 65 or older
• Accompanied in day care or in the geriatric structure of the CHU of Nice (EHPAD-USLD)
• Mild to moderate cognitive impairment
• Diagnostic criteria for Alzheimer's disease, NINCDS-ADRDA probably,
• Positive score on at least one of the following rating scales :
• NPI-ES depression/dysphoria and anxiety items + GDS 15 Patients
• IA caregiver = 2 on one of 2 dimensions + IA patient = 2 on one of 2 dimensions

Exclusion Criteria:

• Diagnosed psychiatric pathology
• Disabling sensory disorders such as DMLA
• Significant hearing loss
• Subjects with risk of photosensitive epilepsy or dizziness. Subjects with Lewy body dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: personalized video; Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).	Procedure: virtual reality session; The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
ACTIVE_COMPARATOR: generic vidéo; The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)	Procedure: virtual reality session; The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression and anxiety assessment	assessment with Hamilton scale	change of Hamilton score between inclusion and 6 weeks (before and after therapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychotropic drugs consumption	assessment of psychotropic drugs consumption	change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Olivier guerin.o@chu-nice.fr, PU-PH, Nice University Hospital, Gerontology Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2020
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (ACTUAL): June 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Mood Disorders
• Other Study ID Numbers: 20-PP-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No