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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-02-01

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer Disease Mood Disorders Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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personalized video

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

Group Type EXPERIMENTAL

virtual reality session

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

virtual reality session

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No