PAG-Macro: Validation of myStrength's Macropersonalization Engine

Sponsor
Teladoc Health (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05417178
Collaborator
(none)
200
1
11
18.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: myStrength Macropersonalization Enginge

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Validation of myStrength's Macropersonalization Engine
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pacific Anxiety Group Menlo Park California United States 94025

Sponsors and Collaborators

  • Teladoc Health

Investigators

  • Study Director: Bobbie James, MStat, Teladoc Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Teladoc Health
ClinicalTrials.gov Identifier:
NCT05417178
Other Study ID Numbers:
  • PAG_Macro 2022
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Teladoc Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022