Virtual RealityREVIVEDNCT07119008
Use of Virtual Reality as a Tool for Cognitive Remediation in Elderly Depressed Patients
A study testing Virtual reality in people with Virtual Reality and Depression, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Virtual Reality, Depression
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Brest - Hôpital de Bohars
Bohars, 29820
Sophie LE BORGNE, Dr, +33 2 98 01 50 27, sophie.leborgne@chu-brest.fr
Christophe LEMEY, Dr
About this study
Official title: Use of Virtual Reality as a Cognitive Remediation Tool in the Depressed Elderly Subject
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.
Read the 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.
- Conditions
- Virtual Reality, Depression
- Being tested
- Virtual reality
- Keywords
- virtual reality
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| use of virtual reality | Experimental | Not described Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of session 12, on average in Week 6
Secondary outcomes (9)
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).
Measured: at the end of the sessions, on average in Week 6
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.
Measured: at inclusion and at the end of the 12 sessions, on average in Week 6
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.
Measured: at inclusion and at the end of the 12 sessions, on average in Week 6
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.
Measured: at inclusion and at the end of the 12 sessions, on average at Week 6
The impact of TERV on executive disorders
The impact of TERV on executive disorders, which will be measured by a neuropsychological evaluation including: WAIS IV digit memory empans test (eschler Adult Intelligence Scale)
Measured: At inclusion and at the end of the 12 sessions, on average at Week 6
The impact of TERV on executive disorders
The impact of TERV on executive disorders, which will be measured by a neuropsychological evaluation including: Dubois test
Measured: At inclusion and at the end of the 12 sessions, on average at Week 6
The impact of TERV on executive disorders
The impact of TERV on executive disorders, which will be measured by a neuropsychological evaluation including: BREF (Rapid Frontal Efficiency Battery) test
Measured: At inclusion and at the end of the 12 sessions, on average at Week 6
The impact of TERV on executive disorders
The impact of TERV on executive disorders, which will be measured by a neuropsychological evaluation including: zoo test
Measured: At inclusion and at the end of the 12 sessions, on average at Week 6
Mental workload induced by VR sessions
Mental workload induced by VR sessions, which will be measured by the NASA-TLX (NASA Task Load Index) in French at the end of each session
Measured: at inclusion and at the end of the 12 sessions, on average at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical investigation of a Class I medical device. Early interventional, uncontrolled, single-center, unblinded trial.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie LE BORGNE, Dr, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119008
- Sponsor's protocol ID
- 29BRC23.0272 - REVIVED
- Acronym
- REVIVED
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality as a Cognitive Remediation Tool in the Depressed Elderly Subject
- ClinicalTrials.gov ID
- NCT07119008
- Acronym / sponsor ID
- REVIVED / 29BRC23.0272 - REVIVED
- Conditions
- Virtual Reality, Depression
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical investigation of a Class I medical device. Early interventional, uncontrolled, single-center, unblinded trial.
| Arm | Type | Receives |
|---|---|---|
| use of virtual reality | Experimental | Device: Virtual reality |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityPatients 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. | Device | use of virtual reality |
Primary outcome
The acceptability of Virtual Reality
Time frame: at the end of session 12, on average in Week 6
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie LE BORGNE, Dr principal investigator
CHU Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Virtual Reality and Depression, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie LE BORGNE, Dr (+33 2 98 01 50 27, sophie.leborgne@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of Virtual Reality (time frame: at the end of session 12, on average in Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.