Use of Virtual Reality as a Tool for Cognitive Remediation in Elderly Depressed Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity Hospital, Brest
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Patients suffering from epilepsy;
Patients suffering from inner ear disorders;
Patients with balance disorders or postural instability;
Patients with swallowing disorders requiring mixed feeding;
Trial design
Design model
Single group
Treatments tested in this trial
Virtual reality
DevicePatients 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: use of virtual realityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The acceptability of Virtual Reality
Virtual Reality acceptability will be assessed using the French version of the Acceptability E-scale questionnaire at the end of session 12. A success/failure criterion will be defined by setting the cut-off point at 24 out of 30. The questionnaire will also be completed at the end of sessions 1 and 6, to provide usable information should a patient withdraw from the protocol prematurely for any reason other than refusal to continue the study. A patient who decides to stop the virtual reality sessions before the 12th session will be considered as a failure.
Time frame
at the end of session 12, on average in Week 6Secondary outcomes
1
TERV tolerance
TERV (Virtual Reality Exposure Therapy) tolerance, which will be assessed by looking for symptoms of cybermalaise using the UQO Cybermalaise Questionnaire at the end of each session. This questionnaire includes 16 symptoms that may be experienced during the virtual reality sessions, similar to motion sickness. At the end of the sessions, the patient is asked to rate them in terms of intensity (not at all, a little, moderately, severely).
Time frame
at the end of the sessions, on average in Week 62
The impact of TERV on depressive symptomatology
The impact of TERV on depressive symptomatology, which will be assessed using the Geriatric Depression Scale (GDS) at inclusion and at the end of the 12th session. This scale comprises 30 yes/no questions on depressive symptomatology. A score of 10 to 19 corresponds to moderate depression, and 20 to 30 to severe depression.
Time frame
at inclusion and at the end of the 12 sessions, on average in Week 63
The impact of TERV on quality of life
The impact of TERV on quality of life, which will be assessed using the Elderly Adapted Quality of Life Scale (EQVPA) at inclusion and at the end of the 12th session. This scale comprises 5 questions, each rated from 0 to 3. The score is between 0 and 15.
Time frame
at inclusion and at the end of the 12 sessions, on average in Week 64
The impact of TERV on executive disorders
The impact of TERV on executive disorders, which will be measured by a neuropsychological evaluation including: Stroop Victoria tst. The assessment will be carried out at inclusion and at the end of the 12th session. These tests target the executive functions of interest in this research, as depression favours the emergence of dysexecutive disorders and the loss of functional abilities in daily life.
Time frame
at inclusion and at the end of the 12 sessions, on average at Week 6Sponsors and contacts
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Source ClinicalTrials.gov
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