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临床试验/NCT04442594
NCT04442594已完成不适用

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

Centre Hospitalier Universitaire de Nice5 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
5
主要终点
Depression and anxiety assessment

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Depression and anxiety assessment

时间窗: change of Hamilton score between inclusion and 6 weeks (before and after therapy)

assessment with Hamilton scale

次要结局

  • psychotropic drugs consumption(change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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