Clinical trial NCT03946319: Personalized, Transdiagnostic Approach to Preventative Mental Health
Official title: A Personalized, Transdiagnostic Approach to Preventative Mental Health Using Machine Learning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Mental Disorders
Delivery of Health Care
Self-Assessment
Diagnosis, Psychiatric
Keywords: Internet Interventions
eMental Health
mHealth
Transdiagnostic
Behavioral Health
Wellness
Connected Health
Introspect
Lead sponsor: Introspect Health
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized either into a control group assigned to the standard of care diagnostic assessments once daily or into an experimental group assigned to the novel, personalized assessment system. The content of both assessment systems is the same, but the approach to delivering the assessments differs based on the arm. Each arm will have 25 participants, and any additional participants who register will be assigned to a waitlist.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Report Adherence Rate
timeFrame: 6 weeks
measure: Completed Assessments Scored
timeFrame: 6 weeks
measure: Assessment Questions Scored
timeFrame: 6 weeks
Secondary outcomes:
measure: Time per Assessment Question
timeFrame: 6 weeks
measure: Response Time
timeFrame: 6 weeks
measure: Assessment Completion Rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Institute of Integral Studies
state: California
Study officials:
affiliation: California Institute of Integral Studies
name: Anne M Huffman, PhD
role: STUDY_DIRECTOR
affiliation: Introspect Health
name: Michael K Owens
role: PRINCIPAL_INVESTIGATOR
References: