Mental HealthNCT03946319
Personalized, Transdiagnostic Approach to Preventative Mental Health
A study testing Introspect Health in people with Mental Health and Mental Disorders, run by Introspect Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Mental Disorders, Delivery of Health Care
- What is being tested?
- Introspect Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2019to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Institute of Integral Studies
San Francisco, California, 94103
Kris Brandenburger, Phd, 415-575-3411, kbrandenburger@ciis.edu
Anne Huffman, Phd, ahuffman@ciis.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Introspect Health
- Keywords
- Internet Interventions, eMental Health, mHealth, Transdiagnostic, Behavioral Health, Wellness, Connected Health, Introspect
- Medical subject headings
- Psychological Well-Being, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introspect HealthDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Introspect Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Report Adherence Rate
Frequency of individuals adhering to the regiment of daily self-assessments, segmented by arm
Measured: 6 weeks
Completed Assessments Scored
Total number of self-assessments completed throughout the study time frame, not including partial assessments, segmented by arm
Measured: 6 weeks
Assessment Questions Scored
Total number of individual questions completed throughout the study time frame, segmented by arm
Measured: 6 weeks
Secondary outcomes (3)
Time per Assessment Question
Average time spent responding to each question during an assessment, segmented by arm and assessment
Measured: 6 weeks
Response Time
Average time from initial assessment prompt to completion of the assessment, segmented by arm and assessment
Measured: 6 weeks
Assessment Completion Rate
Frequency of individuals completing an assessment, segmented by arm and assessment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startMay 2019 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Introspect Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne M Huffman, PhD, Study director, California Institute of Integral StudiesMichael K Owens, Principal investigator, Introspect Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946319
- Sponsor's protocol ID
- IH-001
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be released. Statistical analysis of masked participant data will be published alongside one or more reports.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalized, Transdiagnostic Approach to Preventative Mental Health Using Machine Learning
- ClinicalTrials.gov ID
- NCT03946319
- Acronym / sponsor ID
- IH-001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Introspect HealthIndustry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized, Transdiagnostic Assessments | Experimental | Diagnostic Test: Introspect HealthOne 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. |
| Monotopic Assessments | Active comparator | Diagnostic Test: Introspect HealthOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- English fluency
- US citizen
- California resident
- Eligible to receive mental healthcare in the state of California
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introspect HealthIntrospect 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. | Diagnostic test | Monotopic Assessments, Personalized, Transdiagnostic Assessments |
Primary outcome
Self-Report Adherence Rate
Time frame: 6 weeks
Frequency of individuals adhering to the regiment of daily self-assessments, segmented by arm
Completed Assessments Scored
Time frame: 6 weeks
Total number of self-assessments completed throughout the study time frame, not including partial assessments, segmented by arm
Assessment Questions Scored
Time frame: 6 weeks
Total number of individual questions completed throughout the study time frame, segmented by arm
3 secondary outcomes
Time per Assessment Question
Time frame: 6 weeks
Response Time
Time frame: 6 weeks
Assessment Completion Rate
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No. No IPD will be released. Statistical analysis of masked participant data will be published alongside one or more reports.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne M Huffman, PhD study director
California Institute of Integral Studies
Michael K Owens principal investigator
Introspect Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introspect Health in people with Mental Health and Mental Disorders, run by Introspect Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael K Owens (251-454-6659, mko@introspect.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Report Adherence Rate (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.