Clinical trial NCT04442594: REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Official title: REMINISCENCES : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Mood Disorders
Virtual Reality
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Depression and anxiety assessment
timeFrame: change of Hamilton score between inclusion and 6 weeks (before and after therapy)
Secondary outcomes:
measure: psychotropic drugs consumption
timeFrame: change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
city: Nice
country: France
facility: EPHAD Ancilla
city: Nice
country: France
facility: EPHAD Clos de Cimiez
city: Nice
country: France
facility: Hopital privé Gériatrique Les Sources
Study officials:
affiliation: Nice University Hospital, Gerontology Department
name: Olivier guerin.o@chu-nice.fr, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: