Validation of myStrength's Macropersonalization Engine

• Conditions: Depression, Anxiety; Trauma

• Registration Number: NCT05417178
• Lead Sponsor: Teladoc Health

Brief Summary

This is a study to validate myStrength's macropersonalization algorithm. Specifically, the study seeks to answer: Does myStrength's macropersonalization algorithm match what a clinician would offer as a diagnosis following an expert assessment? Participants will be treatment-seeking adults, ages 18 to 65, recruited from an evidence-based group psychotherapy practice. Participants will be asked to complete myStrength onboarding and a clinician-conducted initial assessment. Inter-rater reliability will be assessed to determine the consistency between myStrength and clinician in primary focus area of digital program.

Detailed Description

Rationale and Background: Macropersonalization refers to the rules applied to a member's onboarding data that dictate their primary clinical focus and available interventions that will be recommended. Macropersonalization is a new myStrength feature that is meant to enable myStrength's ability to deliver evidence-based stepped care.

Research Questions: To examine the inter-rater reliability between myStrength's macropersonalization engine and expert clinical recommendations for members' primary clinical focus.

Study Design: This is a one-arm, prospective study.

Population: Study participants will be adults, ages 18 to 65, seeking therapy at an evidence-based psychotherapy group practice.

Data Sources: Anticipated data sources include members myStrength onboarding data, macropersonalization outputs, and clinician-administered clinical assessments.

Data Analysis: A Cohen's kappa will be generated for agreement between myStrength macro-personalization primary focus area and clinician diagnosis to fulfill the primary objective. Conditional kappas based on stratification, as well as a logistic regression, will be used to determine whether demographics or treatment history are associated with concordance, and qualitative analyes will be used to describe sub-clinical or secondary focus areas associated with clinician diagnoses.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-22
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aged 18 to 85, inclusive
• Able to read, write, and speak in English
• Has access to the Internet to complete study procedures
• Currently engaged in therapy or has schedule an initial appointment with the Pacific Anxiety Group

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inter-rater reliability on primary focus area	Upon completion of initial assessments by subject and clinician within 30 days of signing informed consent.	Inter-rater reliability between myStrength macropersonalization engine and expert clinical recommendation for an individual's primary focus

Trial Locations

Locations (1)

Pacific Anxiety Group; 🇺🇸 Menlo Park, California, United States