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OpenTrials
Completed

NCT Number: NCT04442594

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice, Nice, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual reality session

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.

Primary outcomes

  1. Depression and anxiety assessment

    Time frame: change of Hamilton score between inclusion and 6 weeks (before and after therapy)

    assessment with Hamilton scale

Secondary outcomes

  1. psychotropic drugs consumption

    Time frame: change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)

    assessment of psychotropic drugs consumption

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: REMINISCENCES

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 22, 2020
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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