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

Study Overview
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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

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

Conditions
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Alzheimer Disease, Mood Disorders, Virtual Reality

Intervention / Treatment
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* Procedure: virtual reality session


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: personalized video<br>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<br>* 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.<br>|
| Active Comparator: generic vidéo<br>The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) | Procedure: virtual reality session<br>* 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.<br>|

What is the study measuring?
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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) |