Personalized, Transdiagnostic Approach to Preventative Mental Health

NCT03946319 | Unknown DMC FDA Device

• 1 other identifier: IH-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time per Assessment Question

  6 weeks

• Response Time

  6 weeks

• Assessment Completion Rate

  6 weeks

Study Arms (2)

Personalized, Transdiagnostic Assessments

EXPERIMENTAL

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

Monotopic Assessments

ACTIVE COMPARATOR

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

Interventions

Introspect Health DIAGNOSTIC_TEST

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.

Monotopic Assessments; Personalized, Transdiagnostic Assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Introspect Health: lead

Study Sites (1)

California Institute of Integral Studies

San Francisco, California, 94103, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Mental Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Anne M Huffman, PhD

  California Institute of Integral Studies

  STUDY DIRECTOR

• Michael K Owens

  Introspect Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael K Owens

CONTACT

251-454-6659; mko@introspect.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All relevant participant research data is stored separate from protected health information and potentially identifiable information, including into which study arm the participant has been randomized.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: May 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)