Depression, AnxietyPAG-MacroNCT05417178
Validation of myStrength's Macropersonalization Engine
An observational study of Depression, Anxiety and Trauma, run by Teladoc Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression, Anxiety, Trauma
- What is being tested?
- myStrength Macropersonalization Enginge
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be individuals seeking initial evaluation and treatment at the Pacific Anxiety Group.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pacific Anxiety Group
Menlo Park, California, 94025
Robert Holaway, PhD, 650-762-8352, rob@pacificanxietygroup.com
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Trauma
- Being tested
- myStrength Macropersonalization Enginge
- Keywords
- Sleep, Digital Therapy
- Medical subject headings
- Depression, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myStrength Macropersonalization EngingeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability on primary focus area
Inter-rater reliability between myStrength macropersonalization engine and expert clinical recommendation for an individual's primary focus
Measured: Upon completion of initial assessments by subject and clinician within 30 days of signing informed consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teladoc Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bobbie James, MStat, Study director, Teladoc Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417178
- Sponsor's protocol ID
- PAG_Macro 2022
- Acronym
- PAG-Macro
- Status last verified
- Jun 2022
- First submitted
- 22 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of myStrength's Macropersonalization Engine
- ClinicalTrials.gov ID
- NCT05417178
- Acronym / sponsor ID
- PAG-Macro / PAG_Macro 2022
- Conditions
- Depression, Anxiety, Trauma
- Keywords
- Sleep, Digital Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Teladoc HealthIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be individuals seeking initial evaluation and treatment at the Pacific Anxiety Group.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myStrength Macropersonalization EngingeAn 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. | Other | – |
Primary outcome
Inter-rater reliability on primary focus area
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Depression, Anxiety
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingPhase 1
Microbiota Modulation for Psychiatry Patients
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbie James, MStat study director
Teladoc Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety and Trauma, run by Teladoc Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Yu, PhD (650-804-8434, jessica.yu@teladochealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability on primary focus area (time frame: Upon completion of initial assessments by subject and clinician within 30 days of signing informed consent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.