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

NCT04442594 | Completed

• 1 other identifier: 20-PP-11
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Alzheimer Disease; Mood Disorders; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Depression and anxiety assessment

  assessment with Hamilton scale

  change of Hamilton score between inclusion and 6 weeks (before and after therapy)

Secondary Outcomes (1)

• psychotropic drugs consumption

  change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)

Study Arms (2)

personalized video

EXPERIMENTAL

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

generic vidéo

ACTIVE COMPARATOR

The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)

Procedure: virtual reality session

Interventions

virtual reality session PROCEDURE

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.

generic vidéo; personalized video

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

CHU de Nice

Nice, 06000, France

Location

EPHAD Ancilla

Nice, France

Location

EPHAD Clos de Cimiez

Nice, France

Location

Hopital privé Gériatrique Les Sources

Nice, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Mood Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Olivier guerin.o@chu-nice.fr, PU-PH

  Nice University Hospital, Gerontology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The virtual reality sessions will take place twice a week during 6 weeks. Each subject will have two different virtual environment. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: December 2, 2020
• Primary Completion: March 1, 2022
• Study Completion: February 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)