StressNCT06265909
Prospective Real World Study on Therapy Prediction Algorithm Training
An observational study of Stress and Emotional Wellbeing, run by Mobio Interactive PTE LTD at 1 site in Singapore.
Trial summary
This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional Wellbeing
- What is being tested?
- AmDTx
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2015to 31 Dec 2022
- 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 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AmDTx users at least 18 years old, of any gender, and from any geography and socioeconomic status.
Who may be able to join
- Completion of at least 28 English-language psychotherapy sessions that contained the required session payloads for algorithm inclusion, and only when the objective and two subjective measures were all completed both before and after each session.
Who cannot join
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Real World Study on Therapy Prediction Algorithm Training Using Data From the Mobio Mental Health Platform AmDTx
This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content.
Read the detailed description
From 2,786 unique individuals engaging between March 2015 and December 2022 in English language psychotherapy sessions and providing pre- and post-session self-report and facial biometric data via the AmDTx mental health platform (Mobio Interactive Pte Ltd, Singapore), analysis was conducted on 67 "super users" that completed at least 28 sessions with all pre- and post-session measures. AmDTx is a clinically validated mental health platform that provides patients with audio recordings supporting mental wellbeing (asynchronous and on-demand psychotherapy). AmDTx also contains easy to use tools that rapidly assess mental wellbeing, including an objective measure of psychological stress derived from AI analysis of facial biomarkers (Objective Stress Level; ∆OSL), and ecological momentary assessments (EMAs). Two commonly used EMAs within AmDTx are self-reported stress (∆SRS) and self-reported mood (∆SRM). These three data sources were used to independently train an algorithm designed to predict what future therapy sessions would prove most efficacious for each individual. Algorithm predictions were compared against the efficacy of the individual's self-selected sessions.
- Conditions
- Stress, Emotional Wellbeing
- Being tested
- AmDTx
- Keywords
- Precision psychiatry, Recommendation algorithm, Psychological stress, Remote therapy, Remote monitoring
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmDTxDevice
AmDTx (Mobio Interactive Pte Ltd, Singapore), is an advanced mobile health platform equipped with computer vision and AI to objectively quantify psychological stress and benchmarked ecological momentary assessments to subjectively measure stress, valence, and arousal. Asynchronous and on-demand psychotherapy available as audio files within AmDTx has been clinically validated across the mental illness severity spectrum. Psychotherapy within AmDTx primarily leverages meditation/mindfulness techniques to enhance relaxation, build stress resilience, improve focus and decision making, and influence behaviour and affect bias.
| Study group | Role | What they receive |
|---|---|---|
| AmDTx engaged | Data were collected between March 2015 and December 2022 on 36,160 unique users in a manner compliant with the Health Insurance Portability and Accountability Act (HIPAA), Personal Health Information Protection Act (PHIPA), and General Data Protection Regulation (GDPR). Of these, 2,786 unique individuals engaged in biometric and self-report data collection. To protect the real-world applicability of the results, users were not given any special instruction or information about the nature or possibility of the current analyses. As consequence, user data varied greatly in terms of engagement and app-use characteristics. To create a single, unified, and consistent dataset that could be leveraged across all intended analyses, data were filtered to only include English-language psychotherapy sessions that contained the required session payloads for algorithm inclusion (see below), and only when all the objective and two subjective measures were completed both before and after each session. Receives: Device: AmDTx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Stress Level (OSL)
Objective stress level (∆OSL). Objective stress within AmDTx was obtained via a 30-second "selfie" video captured with the front-facing camera of a mobile device (smartphone or table). The computer vision data extracted from the videos in real time through study completion, an average of 27.1 measures per person per year, were then passed through a deep neural network (DNN) to compute the objective stress level (∆OSL) at that moment in time. ∆OSL is represented with a value between 0 to 1, with greater values representing more stress.
Measured: Continuous
Self-Reported Stress (SRS)
Subjective, self-reported stress (∆SRS). Subjective stress within AmDTx was quantified via an animated digital "slider". Users reported their current level of stress either by dragging a marker on the slider to a position of their choosing between "none" (0) and "extreme" (10), or by tapping on one of four faces positioned above the slider, with each face visually depicting stress levels at the mid-points of four quadrants (i.e., values of 1.25, 3.75, 6.25, 8.75). Users were instructed input the stress that represents how they feel "right here, right now". Data collected in real time through study completion, an average of 27.1 measures per person per year.
Measured: Continuous
Self-Reported Mood (SRM)
Subjective, self-reported mood (∆SRM). Subjective mood within AmDTx was quantified via a "mood board", which asks users to select from 32 different words representing various emotions (e.g., "delighted", "content", "gloomy", "tense"). The mood board consists of two axes, one spanning from "unpleasant" to "pleasant" and the other from "mild" to "intense". Each quadrant contains 8 mood words. Users were instructed to tap on the words that represent how they feel "right here, right now". Data collected in real time through study completion, an average of 27.1 measures per person per year.
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2015
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mobio Interactive PTE LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bechara J Saab, PhD, Principal investigator, Mobio Interactive PTE LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265909
- Sponsor's protocol ID
- PRW001
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Farb N, Saab B. Scalable Precision Psychiatry With an Objective Measure of Psychological Stress: Prospective Real-World Study. J Med Internet Res. 2025 Jul 7;27:e56086. doi: 10.2196/56086.
PubMed 40622759
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real World Study on Therapy Prediction Algorithm Training Using Data From the Mobio Mental Health Platform AmDTx
- ClinicalTrials.gov ID
- NCT06265909
- Acronym / sponsor ID
- PRW001
- Conditions
- Stress, Emotional Wellbeing
- Keywords
- Precision psychiatry, Recommendation algorithm, Psychological stress, Remote therapy, Remote monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mobio Interactive PTE LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Feb 2024 (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.
This study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform AmDTx (Mobio Interactive). The algorithm is to be trained with three separate sources of data. Two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. The third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content.
Detailed description
From 2,786 unique individuals engaging between March 2015 and December 2022 in English language psychotherapy sessions and providing pre- and post-session self-report and facial biometric data via the AmDTx mental health platform (Mobio Interactive Pte Ltd, Singapore), analysis was conducted on 67 "super users" that completed at least 28 sessions with all pre- and post-session measures. AmDTx is a clinically validated mental health platform that provides patients with audio recordings supporting mental wellbeing (asynchronous and on-demand psychotherapy). AmDTx also contains easy to use tools that rapidly assess mental wellbeing, including an objective measure of psychological stress derived from AI analysis of facial biomarkers (Objective Stress Level; ∆OSL), and ecological momentary assessments (EMAs). Two commonly used EMAs within AmDTx are self-reported stress (∆SRS) and self-reported mood (∆SRM). These three data sources were used to independently train an algorithm designed to predict what future therapy sessions would prove most efficacious for each individual. Algorithm predictions were compared against the efficacy of the individual's self-selected sessions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AmDTx engaged | – | Device: AmDTxData were collected between March 2015 and December 2022 on 36,160 unique users in a manner compliant with the Health Insurance Portability and Accountability Act (HIPAA), Personal Health Information Protection Act (PHIPA), and General Data Protection Regulation (GDPR). Of these, 2,786 unique individuals engaged in biometric and self-report data collection. To protect the real-world applicability of the results, users were not given any special instruction or information about the nature or possibility of the current analyses. As consequence, user data varied greatly in terms of engagement and app-use characteristics. To create a single, unified, and consistent dataset that could be leveraged across all intended analyses, data were filtered to only include English-language psychotherapy sessions that contained the required session payloads for algorithm inclusion (see below), and only when all the objective and two subjective measures were completed both before and after each session. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AmDTx users at least 18 years old, of any gender, and from any geography and socioeconomic status.
Key inclusion criteria (1 listed)
- Completion of at least 28 English-language psychotherapy sessions that contained the required session payloads for algorithm inclusion, and only when the objective and two subjective measures were all completed both before and after each session.
Key exclusion criteria (1 listed)
- Under 18 years old
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 |
|---|---|---|
| AmDTxAmDTx (Mobio Interactive Pte Ltd, Singapore), is an advanced mobile health platform equipped with computer vision and AI to objectively quantify psychological stress and benchmarked ecological momentary assessments to subjectively measure stress, valence, and arousal. Asynchronous and on-demand psychotherapy available as audio files within AmDTx has been clinically validated across the mental illness severity spectrum. Psychotherapy within AmDTx primarily leverages meditation/mindfulness techniques to enhance relaxation, build stress resilience, improve focus and decision making, and influence behaviour and affect bias. | Device | AmDTx engaged |
Primary outcome
Objective Stress Level (OSL)
Time frame: Continuous
Objective stress level (∆OSL). Objective stress within AmDTx was obtained via a 30-second "selfie" video captured with the front-facing camera of a mobile device (smartphone or table). The computer vision data extracted from the videos in real time through study completion, an average of 27.1 measures per person per year, were then passed through a deep neural network (DNN) to compute the objective stress level (∆OSL) at that moment in time. ∆OSL is represented with a value between 0 to 1, with greater values representing more stress.
Self-Reported Stress (SRS)
Time frame: Continuous
Subjective, self-reported stress (∆SRS). Subjective stress within AmDTx was quantified via an animated digital "slider". Users reported their current level of stress either by dragging a marker on the slider to a position of their choosing between "none" (0) and "extreme" (10), or by tapping on one of four faces positioned above the slider, with each face visually depicting stress levels at the mid-points of four quadrants (i.e., values of 1.25, 3.75, 6.25, 8.75). Users were instructed input the stress that represents how they feel "right here, right now". Data collected in real time through study completion, an average of 27.1 measures per person per year.
Self-Reported Mood (SRM)
Time frame: Continuous
Subjective, self-reported mood (∆SRM). Subjective mood within AmDTx was quantified via a "mood board", which asks users to select from 32 different words representing various emotions (e.g., "delighted", "content", "gloomy", "tense"). The mood board consists of two axes, one spanning from "unpleasant" to "pleasant" and the other from "mild" to "intense". Each quadrant contains 8 mood words. Users were instructed to tap on the words that represent how they feel "right here, right now". Data collected in real time through study completion, an average of 27.1 measures per person per year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40622759Wang H, Farb N, Saab B. Scalable Precision Psychiatry With an Objective Measure of Psychological Stress: Prospective Real-World Study. J Med Internet Res. 2025 Jul 7;27:e56086. doi: 10.2196/56086.
- 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.
Bechara J Saab, PhD principal investigator
Mobio Interactive PTE LTD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Emotional Wellbeing, run by Mobio Interactive PTE LTD at 1 site in Singapore.
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 1 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: finished, as of the sponsor's last update on 20 Feb 2024. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Stress Level (OSL) (time frame: Continuous). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265909, which also lists 1 linked publication.
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 20 Feb 2024.