NCT03946319

Personalized, Transdiagnostic Approach to Preventative Mental Health

A Personalized, Transdiagnostic Approach to Preventative Mental Health Using Machine Learning

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Introspect Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is investigating the self-report adherence and assessment completion rates when presented with a transdiagnostic, partial assessment multiple times a day when compared with a monotopic, complete assessment once a day. Specifically, the investigators are testing the hypothesis that the personalization of diagnostic assessment topics and timing will lead to improved self-report regiment adherence rates, assessment completion rates, and total assessments completed during the study period. The study does not test the efficacy of the personalized assessments as a diagnostic instrument, there is no clinical decision support provided to clinicians during this study, and there is no treatment provided during this study.

Detailed description

Broadly, the goal of Introspect Health is to shift clinical practice from reactively treating psychiatric disorders and mental health issues once manifested to a preventative care model for integrative mental health in a way that is cost-effective and scalable. One of the principal areas of struggle in preventative mental health is self-report adherence and the ability for primary care physicians and non-psychiatrists to perform mental health surveillance with their patients. This study specifically examines the relationship between individuals and a novel self-report assessment tool. To do this, the investigators are performing a randomized controlled trial with two classes of users (the general public and patients undergoing treatment for mental health issues) for a six week trial comparing the novel self-report assessment tool to the standard of care assessment tools available to clinicians. Participants will be randomized to one of the two daily assessment regiments within the internet-delivered assessment tool: one that is representative of standard of care monitoring and one that is personalized both in terms of content and timing based on the participant's intake as well as ongoing participation. Neither the participants nor researcher will be aware of which arm the individual is randomized. After using the software for six weeks, the data will be analyzed specifically targeting self-adherence and assessment completion metrics to evaluate the potential benefits of a transdiagnostic assessment system over the standard-of-care monotopic assessment system. Assessment scoring is handled by an automated scoring engine, using the rules set forth by the standards in the assessment protocols. The study does not test the efficacy of the personalized assessments as a diagnostic instrument, there is no clinical decision support provided to clinicians during this study, and there is no treatment provided during this study.

Conditions

• Mental Health
• Mental Disorders
• Delivery of Health Care
• Self-Assessment
• Diagnosis, Psychiatric

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Introspect Health	Introspect Health is a software platform which has implemented both the monotopic and personalized, transdiagnostic assessment tools. The software is delivered via the internet using a mobile device or computer.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2019-05-10
• Last updated: 2019-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study