DepressionDEPRIVNCT05019183
Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression
A study testing Physical training, Virtual reality and Single-photon emission computed tomography (SPECT) in people with Depression, run by Direction Centrale du Service de Santé des Armées at 3 sites in France.
Trial summary
Depression is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Physical training, Virtual reality and Single-photon emission computed tomography (SPECT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between the ages of 18 and 65
- with a diagnosis of characterized depressive episode according to the DSM-5 criteria
- able to practice indoor rower.
Who cannot join
- Pregnant or breastfeeding women
- With major depression as part of bipolar affective disorder
- Presence of a suicidal risk
- Under Cognitive behavioral therapy or whose medication has been modified in the month preceding enrollment
- History of neurological pathology, head injury or mental retardation
- Presence of an addictive comorbidity
Show all 10Show fewer
- Presence of a major organic pathology
- Presence of a contraindication to virtual reality exposure
- Presence of a contraindication to SPECT
- Presence of a predisposition to discomfort caused by mobile environments
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Marion TROUSSELARD, MD, PhD, 178651255 ext. +33, marion.trousselard@intradef.gouv.fr
CHU La Conception
Marseille, 13005
Raphaëlle RICHIERI, MD, 491435551 ext. +33, raphaelle.richieri@ap-hm.fr
Institut Fresnel, CERIMED
Marseille, 13005
Eric GUEDJ, MD, PhD, 491385558 ext. +33, eric.guedj@ap-hm.fr
About this study
Depression is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode.
Physical activity, through better management of emotions and stress, has been proposed as a complementary therapeutic approach in depression. Studies have shown a decrease in depressive symptoms during a sports program of at least 2 weeks in addition to pharmacological treatment. Similarly, mindfulness meditation, because it reduces ruminations, could also improve the therapeutic management of depression. More recently, virtual reality (VR) exposure therapy has also been proposed in the treatment of anxiety and depression, with a benefit of multisensory stimulation induced by a virtual environment in cognitive and sensory-motor rehabilitation and emotion regulation. However, these therapeutic strategies, in addition to pharmacological treatments, have limits. There is thus a real challenge in designing innovative therapeutic programs for the treatment of depression that encourage motivated practice. A sports activity coupled with immersion in VR could combine the benefits of each of these treatments. With the emergence of new immersive technologies, VR allows the recreation of sensory experiences in an environment close to the ecological context. The use of physical activity on an indoor rower or other sensor-equipped device could thus intensify the psychological benefits of exercise and improve compliance. However, there is a lack of clinical evidence to recommend this coupled therapeutic approach in the additional treatment of depression. This approach is part of the embodied virtual medicine road map.
Read more
Furthermore, a better understanding of the biological, metabolomic, and cerebral mechanisms underlying this approach could improve its effectiveness. It would make it possible to propose and evaluate biomarkers for therapeutic and prognostic monitoring of depression. In particular, progress in the field of the "-omics" family includes new tools with great potential. This is more specifically the case of metabolomics. The analysis of metabolites present in the organism or released with natural secretions would allow to constitute a metabolomic signature evolving during the treatment. The interest in characterizing metabolomic biomarkers is an interesting avenue to meet the need to establish a biological diagnosis with quantified values, for better objectivity and follow-up. Functional imaging could also be used to highlight regional activity or connectivity anomalies and markers of response to therapy in relation to biology.
The aim of this work is to determine the clinical impact of physical exercise in VR on a depressive state, and to study in biology, metabolomics and neuroimaging the functional substrates of such a practice in order to understand the mechanisms involved and to propose ways to improve the management of depression.
- Conditions
- Depression
- Being tested
- Physical training, Virtual reality, Single-photon emission computed tomography (SPECT), Metabolomics
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
The subjects will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) with a target heart rate zone of 60%.
Virtual realityOther
The subjects will be able to move freely in virtual environments while training on the indoor rower.
Single-photon emission computed tomography (SPECT)Device
SPECT allows the measurement of cerebral perfusion, reflecting the global synaptic activity, via a 3D acquisition of 20 minutes, 15 minutes after injection of 740 MBq of radiotracers (ECD - Neurolite or HMPAo - Cerestab), with iterative reconstruction. The data will be processed at the voxel scale by the SPM12 software, with analysis of brain connectivity.
MetabolomicsBiological
This qualitative approach will aim to identify pathways that are not known (or have not been explored) to optimize the chances of detecting metabolites present depending on the group (physical activity coupled or not with VR). This method is favorable for biomarker discovery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients in the experimental arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) during which they will be able to move freely in a virtual environment. Receives: Other: Physical training; Other: Virtual reality; Device: Single-photon emission computed tomography (SPECT); Biological: Metabolomics |
| Control arm | Other | Patients in the control arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) without being exposed to a virtual environment. Receives: Other: Physical training; Device: Single-photon emission computed tomography (SPECT); Biological: Metabolomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Questionnaire Inventory of Depressive Symptomatology (QIDS-SR) depression scale score between Day 1 and Day 10
This questionnaire is built on the 9 symptoms used in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5): sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decreased/increased appetite or weight, and psychomotor slowing/agitation.
The total score ranges from 0 to 27 with higher scores meaning higher levels of depression.
Measured: From Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into 2 arms: * Experimental arm: patients will beneficiate from a training program in an immersive environment (virtual reality) * Control group: patients will beneficiate from a training program in a real (non-virtual) environment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019183
- Sponsor's protocol ID
- 2020PBMD05
- Other IDs
- 2020-A03415-34
- Acronym
- DEPRIV
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression
- ClinicalTrials.gov ID
- NCT05019183
- Acronym / sponsor ID
- DEPRIV / 2020PBMD05
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 Aug 2021 (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 is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode.
Physical activity, through better management of emotions and stress, has been proposed as a complementary therapeutic approach in depression. Studies have shown a decrease in depressive symptoms during a sports program of at least 2 weeks in addition to pharmacological treatment. Similarly, mindfulness meditation, because it reduces ruminations, could also improve the therapeutic management of depression. More recently, virtual reality (VR) exposure therapy has also been proposed in the treatment of anxiety and depression, with a benefit of multisensory stimulation induced by a virtual environment in cognitive and sensory-motor rehabilitation and emotion regulation. However, these therapeutic strategies, in addition to pharmacological treatments, have limits. There is thus a real challenge in designing innovative therapeutic programs for the treatment of depression that encourage motivated practice. A sports activity coupled with immersion in VR could combine the benefits of each of these treatments. With the emergence of new immersive technologies, VR allows the recreation of sensory experiences in an environment close to the ecological context. The use of physical activity on an indoor rower or other sensor-equipped device could thus intensify the psychological benefits of exercise and improve compliance. However, there is a lack of clinical evidence to recommend this coupled therapeutic approach in the additional treatment of depression. This approach is part of the embodied virtual medicine road map.
Furthermore, a better understanding of the biological, metabolomic, and cerebral mechanisms underlying this approach could improve its effectiveness. It would make it possible to propose and evaluate biomarkers for therapeutic and prognostic monitoring of depression. In particular, progress in the field of the "-omics" family includes new tools with great potential. This is more specifically the case of metabolomics. The analysis of metabolites present in the organism or released with natural secretions would allow to constitute a metabolomic signature evolving during the treatment. The interest in characterizing metabolomic biomarkers is an interesting avenue to meet the need to establish a biological diagnosis with quantified values, for better objectivity and follow-up. Functional imaging could also be used to highlight regional activity or connectivity anomalies and markers of response to therapy in relation to biology.
The aim of this work is to determine the clinical impact of physical exercise in VR on a depressive state, and to study in biology, metabolomics and neuroimaging the functional substrates of such a practice in order to understand the mechanisms involved and to propose ways to improve the management of depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into 2 arms: * Experimental arm: patients will beneficiate from a training program in an immersive environment (virtual reality) * Control group: patients will beneficiate from a training program in a real (non-virtual) environment
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Physical training, Other: Virtual reality, Device: Single-photon emission computed tomography (SPECT), Biological: MetabolomicsPatients in the experimental arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) during which they will be able to move freely in a virtual environment. |
| Control arm | Other | Other: Physical training, Device: Single-photon emission computed tomography (SPECT), Biological: MetabolomicsPatients in the control arm will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) without being exposed to a virtual environment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients between the ages of 18 and 65
- with a diagnosis of characterized depressive episode according to the DSM-5 criteria
- able to practice indoor rower.
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- With major depression as part of bipolar affective disorder
- Presence of a suicidal risk
- Under Cognitive behavioral therapy or whose medication has been modified in the month preceding enrollment
- History of neurological pathology, head injury or mental retardation
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 |
|---|---|---|
| Physical trainingThe subjects will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) with a target heart rate zone of 60%. | Other | Control arm, Experimental arm |
| Virtual realityThe subjects will be able to move freely in virtual environments while training on the indoor rower. | Other | Experimental arm |
| Single-photon emission computed tomography (SPECT)SPECT allows the measurement of cerebral perfusion, reflecting the global synaptic activity, via a 3D acquisition of 20 minutes, 15 minutes after injection of 740 MBq of radiotracers (ECD - Neurolite or HMPAo - Cerestab), with iterative reconstruction. The data will be processed at the voxel scale by the SPM12 software, with analysis of brain connectivity. | Device | Control arm, Experimental arm |
| MetabolomicsThis qualitative approach will aim to identify pathways that are not known (or have not been explored) to optimize the chances of detecting metabolites present depending on the group (physical activity coupled or not with VR). This method is favorable for biomarker discovery. | Biological | Control arm, Experimental arm |
Primary outcome
Change in the Questionnaire Inventory of Depressive Symptomatology (QIDS-SR) depression scale score between Day 1 and Day 10
Time frame: From Day 1 to Day 10
This questionnaire is built on the 9 symptoms used in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5): sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decreased/increased appetite or weight, and psychomotor slowing/agitation. The total score ranges from 0 to 27 with higher scores meaning higher levels of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training, Virtual reality and Single-photon emission computed tomography (SPECT) in people with Depression, run by Direction Centrale du Service de Santé des Armées at 3 sites 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion TROUSSELARD, MD, PhD (178651255 ext. +33, marion.trousselard@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Questionnaire Inventory of Depressive Symptomatology (QIDS-SR) depression scale score between Day 1 and Day 10 (time frame: From Day 1 to Day 10). 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 31 Aug 2021.