Prospective Real World Study on Therapy Prediction Algorithm Training

NCT06265909 | Completed

• 1 other identifier: PRW001
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Emotional Wellbeing

Keywords

Precision psychiatry; Recommendation algorithm; Psychological stress; Remote therapy; Remote monitoring

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Continuous

Study Arms (1)

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.

Device: AmDTx

Interventions

AmDTx DEVICE

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.

AmDTx engaged

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AmDTx users at least 18 years old, of any gender, and from any geography and socioeconomic status.

You may not qualify if:

• Under 18 years old

Sponsors & Collaborators

• Mobio Interactive PTE LTD: lead

Study Sites (1)

Mobio Interactive Pte Ltd

Singapore, 389637, Singapore

Location

Related Publications (1)

• 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.

  PMID: 40622759 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Bechara J Saab, PhD

  Mobio Interactive PTE LTD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)