Validation of myStrength's Macropersonalization Engine

NCT ID: NCT05417178

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Depression, Anxiety Trauma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teladoc Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bobbie James, MStat

Role: STUDY_DIRECTOR

Teladoc Health

Locations

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Pacific Anxiety Group

Menlo Park, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Yu, PhD

Role: CONTACT

650-804-8434

Sravanthi Dama, MD, MPH

Role: CONTACT

347-645-0140

Facility Contacts

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Robert Holaway, PhD

Role: primary

650-762-8352

Other Identifiers

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PAG_Macro 2022

Identifier Type: -

Identifier Source: org_study_id

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