Prospective Real World Study on Therapy Prediction Algorithm Training

Stress Clinical Trial

Official title:

Prospective Real World Study on Therapy Prediction Algorithm Training Using Data From the Mobio Mental Health Platform AmDTx

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06265909
• Other study ID #: PRW001
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Mobio Interactive PTE LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Under 18 years old

Related Conditions & MeSH terms

• Emotional Wellbeing
• Stress

Intervention

Device:
• AmDTx
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.

Locations

Country	Name	City	State
Singapore	Mobio Interactive Pte Ltd	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Mobio Interactive PTE LTD

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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