Personalized, Transdiagnostic Approach to Preventative Mental Health

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

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.

Study Overview

• Status: Unknown
• Conditions: Mental Disorders; Mental Health; Delivery of Health Care; Self-Assessment; Diagnosis, Psychiatric
• Intervention / Treatment: Diagnostic test: Introspect Health

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94103
      • Recruiting
      • California Institute of Integral Studies
      • Contact: Kris Brandenburger, Phd; Phone Number: 415-575-3411; Email: kbrandenburger@ciis.edu
      • Contact: Anne Huffman, Phd; Email: ahuffman@ciis.edu
      • Principal Investigator: Michael K Owens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 or older
• English fluency
• US citizen
• California resident
• Eligible to receive mental healthcare in the state of California
• Primary user of a smartphone device
• Daily access to Internet and email
• Meets a minimum level of 2.51 or higher on a self-rated technology use scale based on the average score of three Likert-style questions
• Willing to answer questions about themselves pertaining to physical and mental wellness throughout the Research Period

Exclusion Criteria:

• Undergoing care for condition requiring emergent treatment or hospitalization, including but not limited to: current or recent (within 3 months) acute manic or major depressive episode, clear and current suicidal risk, current or recent (within 3 months) history of substance abuse or drug dependence
• Undergoing active treatment for a condition wherein the additional burden of performing daily assessments may interfere with their pre-existing treatment regiment, cause undue anxiety, or risk inflammation of pre-existing issues
• Undergoing active treatment using a treatment modality that may adversely interact with research study participation such as psychopharmaceuticals affecting memory and cognition, therapeutic digital detox, or similar treatments
• Has ever participated in a Research Study testing the efficacy of transdiagnostic assessments, transdiagnostic interventions, or Internet-based CBT
• Additionally, patients on psychotropic medications are only eligible to be included while they maintain a stable dosage of their medication; if their medication dosage needs to change for any reason during the course of the Research Study, they would be required to withdraw from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized, Transdiagnostic Assessments; One or more times per day, participants in the Experimental Arm will be presented with a variable-length assessment based on the personalization algorithm. The assessment will include a dynamic number of questions based on personalized relevancy, engagement level, and assessment completion metrics. Questions are scored immediately upon submission, regardless of how many questions are answered. As questions are scored, the personalization algorithm takes the previous responses and response times into consideration when determining what and when to ask additional questions.	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.
Active Comparator: Monotopic Assessments; Once daily, participants in the Control Arm will be presented with the standard of care mental health surveillance assessments identified as relevant upon intake. The assessments will be scored in totality or not at all and have a fixed, predefined number of questions. No personalization of assessment will take place.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Report Adherence Rate	Frequency of individuals adhering to the regiment of daily self-assessments, segmented by arm	6 weeks
Completed Assessments Scored	Total number of self-assessments completed throughout the study time frame, not including partial assessments, segmented by arm	6 weeks
Assessment Questions Scored	Total number of individual questions completed throughout the study time frame, segmented by arm	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time per Assessment Question	Average time spent responding to each question during an assessment, segmented by arm and assessment	6 weeks
Response Time	Average time from initial assessment prompt to completion of the assessment, segmented by arm and assessment	6 weeks
Assessment Completion Rate	Frequency of individuals completing an assessment, segmented by arm and assessment	6 weeks

Collaborators and Investigators

• Sponsor: Introspect Health
• Investigators: Study Director: Anne M Huffman, PhD, California Institute of Integral Studies; Principal Investigator: Michael K Owens, Introspect Health

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: mHealth; Internet Interventions; Behavioral Health; Transdiagnostic; Wellness; eMental Health; Connected Health; Introspect
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: IH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be released. Statistical analysis of masked participant data will be published alongside one or more reports.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No