Anxiety DisordersEMOACQ-1NCT05988840
Acquisition and Analysis of Relationships Between Longitudinal Emotional Signals Produced by an Artificial Intelligence Algorithm and Self-questionnaires Used in the Psychiatric Follow-up of Patients With Mood and/or Anxiety Disorders: a Real-Environment Study.
An observational study of Anxiety Disorders and Major Depressive Disorder, run by Emobot.
Trial summary
The worldwide prevalence of anxiety and depression increased massively during the pandemic, with a 25% rise in the number of patients suffering from psychological distress. Psychiatrists, and even more so general practitioners, need measurement tools that enable them to remotely monitor their patients' psychological… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Major Depressive Disorder
- What is being tested?
- Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2023to 17 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The first cohort of 20 participants will be provided with the 20 measuring embedded device, we will be able to collect specific data at targeted times and for specific activities. The second cohort formed with the remaining participants will receive the software on their personal computer, enabling us to capture more general data and analyze behavior patterns in less controlled contexts.
Who may be able to join
- Persons over the age of 18 who volunteer to take part in research
- Must have access to a computer with an Internet connection,
- Written comprehension of French.
Who cannot join
- N/A
Trial locations and contacts
No sites are listed yet.
About this study
The worldwide prevalence of anxiety and depression increased massively during the pandemic, with a 25% rise in the number of patients suffering from psychological distress. Psychiatrists, and even more so general practitioners, need measurement tools that enable them to remotely monitor their patients' psychological state of health, and to be automatically alerted in the event of a break in behavior.
In this study, the investigators propose to collect clinical data along with longitudinal measurement of patients' emotions. Emobot proposes to analyze the evolution of mood disorders over time by passively studying people's emotional behavior. The aim of EMOACQ-1 is to acquire knowledge and produce a quantitative link between emotional expression and mood disorders, ultimately facilitating the understanding and management of these disorders.
Read more
Through this study, could be developed a technological solution to support healthcare professionals and patients in psychiatry, a field known as the "poor relation of medicine" and lacking in resources. Such a solution would enable better understanding, disorders remote \& continuous monitoring and, ultimately, better treatment of these disorders.
The investigators will process the data by carrying out a number of analyses, including descriptive, comparative and correlation studies of the data from the self-questionnaire results and the emotional signals captured by the devices.
Finally, the aim will be to predict questionnaire scores from the emotional signals produced.
- Conditions
- Anxiety Disorders, Major Depressive Disorder
- Being tested
- Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.Other
Using the tool developed by Emobot, EMOACQ-1 is a study that passively and non-interventionaly collects data by capturing patients' facial expressions throughout the day, and then measures the correlation between emotional signals and the results of measurement questionnaires used in psychiatry.
| Study group | Role | What they receive |
|---|---|---|
| The hardware group (on-board camera) | A physical device equipped with a camera and embedding the acquisition/monitoring software. Positioned in the living space, it will be possible to capture the facial expressions of the person in ecology, for example when watching a TV program or reading. Receives: Other: Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires. | |
| The software-only group (running on a PC or tablet and using the available webcam) | Software running on a computer, connected to the computer's camera (webcam). If the person is teleworking on a PC, it is expected that images will be captured during videoconferencing-type interactions. Receives: Other: Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated measurements Correlations between emotional signals and studied disorders standardized tests.
Repeated measurements Correlations between emotional signals and studied disorders standardized tests.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start17 Oct 2023 (estimated)
- Primary completion17 Aug 2024 (estimated)
- Study completion17 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emobot
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988840
- Sponsor's protocol ID
- 2023-A01589-36
- Acronym
- EMOACQ-1
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Analysis of Relationships Between Longitudinal Emotional Signals Produced by an Artificial Intelligence Algorithm and Self-questionnaires Used in the Psychiatric Follow-up of Patients With Mood and/or Anxiety Disorders: a Real-Environment Study.
- ClinicalTrials.gov ID
- NCT05988840
- Acronym / sponsor ID
- EMOACQ-1 / 2023-A01589-36
- Conditions
- Anxiety Disorders, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EmobotIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (estimated)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 17 Oct 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
The worldwide prevalence of anxiety and depression increased massively during the pandemic, with a 25% rise in the number of patients suffering from psychological distress. Psychiatrists, and even more so general practitioners, need measurement tools that enable them to remotely monitor their patients' psychological state of health, and to be automatically alerted in the event of a break in behavior.
In this study, the investigators propose to collect clinical data along with longitudinal measurement of patients' emotions. Emobot proposes to analyze the evolution of mood disorders over time by passively studying people's emotional behavior. The aim of EMOACQ-1 is to acquire knowledge and produce a quantitative link between emotional expression and mood disorders, ultimately facilitating the understanding and management of these disorders.
Through this study, could be developed a technological solution to support healthcare professionals and patients in psychiatry, a field known as the "poor relation of medicine" and lacking in resources. Such a solution would enable better understanding, disorders remote \& continuous monitoring and, ultimately, better treatment of these disorders.
The investigators will process the data by carrying out a number of analyses, including descriptive, comparative and correlation studies of the data from the self-questionnaire results and the emotional signals captured by the devices.
Finally, the aim will be to predict questionnaire scores from the emotional signals produced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The hardware group (on-board camera) | – | Other: Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.A physical device equipped with a camera and embedding the acquisition/monitoring software. Positioned in the living space, it will be possible to capture the facial expressions of the person in ecology, for example when watching a TV program or reading. |
| The software-only group (running on a PC or tablet and using the available webcam) | – | Other: Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.Software running on a computer, connected to the computer's camera (webcam). If the person is teleworking on a PC, it is expected that images will be captured during videoconferencing-type interactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The first cohort of 20 participants will be provided with the 20 measuring embedded device, we will be able to collect specific data at targeted times and for specific activities. The second cohort formed with the remaining participants will receive the software on their personal computer, enabling us to capture more general data and analyze behavior patterns in less controlled contexts.
Key inclusion criteria (3 listed)
- Persons over the age of 18 who volunteer to take part in research
- Must have access to a computer with an Internet connection,
- Written comprehension of French.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Acquisition and analysis of relationships between Longitudinal Emotional Signals produced by a software and Self-questionnaires.Using the tool developed by Emobot, EMOACQ-1 is a study that passively and non-interventionaly collects data by capturing patients' facial expressions throughout the day, and then measures the correlation between emotional signals and the results of measurement questionnaires used in psychiatry. | Other | The hardware group (on-board camera), The software-only group (running on a PC or tablet and using the available webcam) |
Primary outcome
Repeated measurements Correlations between emotional signals and studied disorders standardized tests.
Time frame: 10 months
Repeated measurements Correlations between emotional signals and studied disorders standardized tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- D. Agarwal et al. From Multimodal to Unimodal Attention in Transformers using Knowledge Distillation. Nov 2021, Virtual, United States.Link provided by the sponsor.
- Mamadou Dia et al. A Novel Stochastic Transformer-based Approach for Post-Traumatic Stress Disorder Detection using Audio Recording of Clinical Interviews, CBMS, June 2023.Link provided by the sponsor.
- J. Gratch et al. The Distress Analysis Interview Corpus of Human and Computer Interviews.Link provided by the sponsor.
- X. Kong et al. Automatic Identification of Depression Using Facial Images with Deep Convolutional Neural Network.Link provided by the sponsor.
- Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Major Depressive Disorder, run by Emobot.
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 1 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Tanel Petelot (+33 51 44 26 67 ext. +33, tanel.petelot@emobot.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated measurements Correlations between emotional signals and studied disorders standardized tests. (time frame: 10 months). 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 15 Aug 2023.