Recruiting

Preventative Mental Health

Sponsor:

Introspect Health

Code:

NCT03946319

Conditions

Mental Health

Mental Disorders

Delivery of Health Care

Self-Assessment

Diagnosis, Psychiatric

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Introspect Health

Study Details

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

Study ID

NCT03946319

Start date

May, 2019

Status verified date

May, 2019

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Self-Report Adherence Rate [ Time Frame: 6 weeks ]
  • Completed Assessments Scored [ Time Frame: 6 weeks ]
  • Assessment Questions Scored [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Michael K Owens

251-454-6659mko@introspect.co

Locations

California Institute of Integral Studies

Recruiting

San Francisco, California, United States, 94103

Contacts

Kris Brandenburger, Phd

415-575-3411kbrandenburger@ciis.edu

Anne Huffman, Phd

ahuffman@ciis.edu

Principal Investigator:

Michael K Owens

More Information

Sponsor

Introspect Health

Last update posted

May 14, 2019

Last verified

May, 2019

Keywords

  • Internet Interventions
  • eMental Health
  • mHealth
  • Transdiagnostic
  • Behavioral Health
  • Wellness
  • Connected Health
  • Introspect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Introspect Health on 2019-05-14.