Clinical trial NCT05417178: Validation of myStrength's Macropersonalization Engine
Official title: Validation of myStrength's Macropersonalization Engine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression, Anxiety
Trauma
Keywords: Sleep
Digital Therapy
Lead sponsor: Teladoc Health
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be individuals seeking initial evaluation and treatment at the Pacific Anxiety Group.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inter-rater reliability on primary focus area
timeFrame: Upon completion of initial assessments by subject and clinician within 30 days of signing informed consent.
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Pacific Anxiety Group
state: California
Study officials:
affiliation: Teladoc Health
name: Bobbie James, MStat
role: STUDY_DIRECTOR
References: