Facilitating Assessment of At-Risk Sailors Using Technology

Study Overview
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Brief Summary
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Randomized clinical trial with individuals being allocated to experimental (Cogito Companion) or Active Control arms. Those in the latter will receive information regarding widely available mobile self-help apps via a custom mobile app built in MyCAP. This same platform will be used to collect data regarding symptoms. Randomization will be stratified by gender, force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms differ based on smartphone platforms. Participants will be willing Naval personnel being redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform future implementation..

Official Title
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Facilitating Assessment of At-Risk Sailors Using Technology

Conditions
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Psychological Distress

Intervention / Treatment
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* Device: Experimental - Cogito Companion
* Behavioral: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria. Member of the Navel Surface or Aviation Forces; Age: 18-55 years at the time of enrollment; Ability to provide verbal and electronic informed consents; Ownership of smartphone; Willingness to use smartphone and personal data plan to participate. Exclusion Criteria. Having redeployed (returning to the Continental United States) more than twelve months (approximately) prior to consent. Having an iPhone (until later in 2019 when the Cogito Corporation plans to release the iOS version of the Cogito Companion app).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental - Cogito Companion<br>Those allocated to Experimental arm will have access the Cogito Companion for a three-month period post-consent. Passive data collection will also occur during this period. As a secure, privacy-compliant mobile app, the Cogito Companion facilitates the non-invasive collection, transfer, integration, analysis, and reporting of objective behavioral indicators. The Cogito mobile sensing platform passively gathers behavioral information through an individual's normal smartphone usage. Measurements of location, call, and text patterns are recorded. | Device: Experimental - Cogito Companion<br>* Cogito Companion<br>|
| Active Comparator: Active Control<br>Participants randomized to the Active Control group will download MyCAP and have access to resources housed within this app for a three-month period post-consent. Participants will be provided information regarding the mHealth Tool apps, and provided basic information on how to download the apps. As noted above, participants will be provided biweekly surveys . | Behavioral: Active Control<br>* Use of MyCAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Distress | Outcome Questionnaire-45 | After the 3 month interventional period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Treatment Engagement During Study Period | Review of Electronic Medical Records and Self Report | After the 3 month interventional period | 
| Number of Treatment Sessions Attended | Review of Electronic Medical Record and Self Report | After the 3 month interventional period |