Validation of myStrength's Macropersonalization Engine

Trauma Clinical Trial

— PAG-Macro  

Official title:

Validation of myStrength's Macropersonalization Engine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417178
• Other study ID #: PAG_Macro 2022
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2022
• Source: Teladoc Health
• Contact: Jessica Yu, PhD
• Phone: 650-804-8434
• Email: jessica.yu[@]teladochealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Trauma

Intervention

Other:
• myStrength Macropersonalization Enginge
An onboarding process that utilizes the PHQ-9, GAD-7, and WHO-5 that leads to a user of the digital program's clinical focus and primary, secondary, and tertiary intervention recommendations.

Locations

Country	Name	City	State
United States	Pacific Anxiety Group	Menlo Park	California

Sponsors (1)

Lead Sponsor	Collaborator
Teladoc Health

Country where clinical trial is conducted

United States, 

Outcome

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