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

Not Applicable
Completed
Conditions
Mood Disorders
Virtual Reality
Alzheimer Disease
Interventions
Procedure: virtual reality session
Registration Number
NCT04442594
Lead Sponsor
Centre Hospitalier Universitaire de Nice
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
generic vidéovirtual reality sessionThe subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)
personalized videovirtual reality sessionEach subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).
Primary Outcome Measures
NameTimeMethod
Depression and anxiety assessmentchange of Hamilton score between inclusion and 6 weeks (before and after therapy)

assessment with Hamilton scale

Secondary Outcome Measures
NameTimeMethod
psychotropic drugs consumptionchange in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)

assessment of psychotropic drugs consumption

Trial Locations

Locations (4)

EPHAD Ancilla

🇫🇷

Nice, France

CHU de Nice

🇫🇷

Nice, France

EPHAD Clos de Cimiez

🇫🇷

Nice, France

Hopital privé Gériatrique Les Sources

🇫🇷

Nice, France

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