Use of Virtual Reality as a Tool for Cognitive Remediation in Elderly Depressed Patients

Official title

Use of Virtual Reality as a Cognitive Remediation Tool in the Depressed Elderly Subject

Overview

Depression, the most common mental disorder affecting the elderly, represents a major public health issue. This pathology leads to a loss of activity and autonomy in the elderly. It impairs executive skills, enabling a person to take initiatives, perform goal-oriented actions and adapt to new situations. Impaired executive functions greatly increase the risk of loss of autonomy and institutionalization, as well as the burden on caregivers. Antidepressant treatments have little or no effect on cognitive disorders. It therefore appears necessary to offer these patients specific treatment of these cognitive symptoms. The investigators are interested in cognitive remediation based on virtual reality (VR) for its ecological and modular characteristics, the innovative aspect of this technique, the appeal of virtual experiences, and their easy access to the general public. The main objective of this study is to demonstrate the acceptability of the VR technique in a population of subjects aged 70 and over, suffering from cognitive disorders and associated depression. In this study the investigators support the use of VR as a tool for cognitive remediation and ecological staging of their interactions with caregivers in the face of executive disorders found in patients suffering from depression. By improving their cognitive skills, VR brings greater autonomy and improved quality of life for patients and their caregivers. The investigators therefore plan to use a virtual environment to create scenarios that reproduce real-life situations, which appear to be more relevant than conventional cognitive remediation exercises. The investigators chose acceptability as the main criterion for this technique, as the elderly population is identified as a sensitive population in the opinion issued by ANSES in June 2021. What's more, this population is often excluded from the new digital technologies; it therefore seems interesting to look at the acceptability of virtual reality by this elderly population.

Detailed description

Every patient diagnosed with depression receives psychotropic treatment comprising one or more antidepressants, possibly combined with one or more thymoregulators (e.g. bipolar patients), one or more anxiolytics and/or a hypnotic. The elderly depressive patient is also treated with supportive psychotherapy and/or group therapy at the day hospital. The trial proposes an additional tool, virtual reality, aimed at improving the cognitive abilities, particularly executive abilities, of the elderly depressive subject, thereby helping to maintain his or her functional abilities, i.e. his or her ability to stay as autonomous as possible at home and maintain a good quality of life. In fact, cognitive disorders associated with depression do not respond to antidepressant medication, if at all. It therefore seems important to optimize the treatment of depression in the elderly subject by adding a cognitive target. The investigators's project is to offer patients the opportunity to live in a virtual kitchen, where they can carry out everyday tasks. The scenario for the VR sessions has been designed in collaboration with, the principal investigator at CHU and his team, and the members of B COM and HDG involved in the study. Particular attention is paid to the fact that this scenario is intended for an elderly patient population, so as to prevent as far as possible the occurrence of cybermalaise The patient will be asked to arrange food shopping appropriately, differentiating between perishable and non-perishable foodstuffs and non-food items, or to prepare cooking recipes. Virtual reality has the advantage of being able to offer ecological, configurable activities, targeting precise tasks that call on executive functions such as initiative, anticipation and planning, mental flexibility and inhibition. Patients will undergo 12 VR sessions at a rate of 2 sessions per week for 6 weeks.

Interventions

• Device Virtual reality
  Patients will perform 12 virtual reality sessions at a rate of 2 sessions per week for 6 weeks. The patient will be offered to properly store food groceries by differentiating perishable or non-perishable foods from non-food items, or to prepare cooking recipes.

Primary outcome measures

• The acceptability of Virtual Reality [Time frame: at the end of session 12, on average in Week 6]

Secondary outcome measures (9)

• TERV tolerance [Time frame: at the end of the sessions, on average in Week 6]
• The impact of TERV on depressive symptomatology [Time frame: at inclusion and at the end of the 12 sessions, on average in Week 6]
• The impact of TERV on quality of life [Time frame: at inclusion and at the end of the 12 sessions, on average in Week 6]
• The impact of TERV on executive disorders [Time frame: at inclusion and at the end of the 12 sessions, on average at Week 6]
• The impact of TERV on executive disorders [Time frame: At inclusion and at the end of the 12 sessions, on average at Week 6]
• The impact of TERV on executive disorders [Time frame: At inclusion and at the end of the 12 sessions, on average at Week 6]
• The impact of TERV on executive disorders [Time frame: At inclusion and at the end of the 12 sessions, on average at Week 6]
• The impact of TERV on executive disorders [Time frame: At inclusion and at the end of the 12 sessions, on average at Week 6]
• Mental workload induced by VR sessions [Time frame: at inclusion and at the end of the 12 sessions, on average at Week 6]

Eligibility criteria

Inclusion criteria

• Patients aged 70 or over;
• Patient with a characterized depressive episode as assessed by the GDS (Score > 13 at inclusion);
• Patient with a minimum MMS score of 23/30 at inclusion;
• Patient affiliated to or benefiting from a social security scheme;
• Patient having received information on the protocol and having given free, informed and written consent.

Exclusion criteria

• Patients suffering from epilepsy;
• Patients suffering from inner ear disorders;
• Patients with balance disorders or postural instability;
• Patients with swallowing disorders requiring mixed feeding;
• Patients suffering from migraines;
• Patients with major sensory deficits (visual or auditory);
• Patients suffering from eye pathologies or abnormalities, and whose condition strictly contraindicates virtual reality;
• Patients suffering from oculo-motor disorders;
• Patients with sensory-motor deficits affecting the upper limb(s) that prevent them from performing the tasks required during VR sessions;
• Patients suffering from primary neuropathic disorders or secondary to metabolic pathologies;
• Patients suffering from acute psychiatric decompensation that makes it impossible for them to cooperate with the sessions (opposition, agitation, acute delusions, hallucinations, panic attacks);
• Patients with uncontrolled cardiac pathology (angina, heart failure, rhythm disorders, conduction disorders);
• Patients with uncontrolled hypertension (SBP > 140 mmHg and DBP > 90 mmHg in patients with traited hypertension);
• Patients with implanted medical devices (pacemakers, defibrillators, etc.);
• Patients under legal protection (guardianship) or deprived of liberty.
• Patients who do not speak or read French fluently, unable to understand the principle of the study questionnaires and unable to cooperate with the tests.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• CHU Brest - Hôpital de Bohars — Bohars

Identifiers

NCT: NCT07119008 · 29BRC23.0272 - REVIVED

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗