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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT04442594

Collaborator

(none)

Enrollment

Locations

Arms

26.9

Anticipated Duration (Months)

7.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Mood Disorders Virtual Reality	Procedure: virtual reality session	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 2, 2020

Actual Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: personalized video 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 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.
Active Comparator: generic vidéo The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)	Procedure: 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.

Arm

Intervention/Treatment

Experimental: personalized video

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

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.

Active Comparator: generic vidéo

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

Procedure: virtual reality session

Outcome Measures

Primary Outcome Measures

Depression and anxiety assessment [change of Hamilton score between inclusion and 6 weeks (before and after therapy)]
assessment with Hamilton scale

Secondary Outcome Measures

psychotropic drugs consumption [change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)]
assessment of psychotropic drugs consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Nice	Nice	France	06000
2	EPHAD Ancilla	Nice	France
3	EPHAD Clos de Cimiez	Nice	France
4	Hopital privé Gériatrique Les Sources	Nice	France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Olivier guerin.o@chu-nice.fr, PU-PH, Nice University Hospital, Gerontology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04442594

Other Study ID Numbers:

20-PP-11

First Posted:

Jun 22, 2020

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Mood Disorders

Study Results

No Results Posted as of May 27, 2022