Facilitating Assessment of At-Risk Sailors Using Technology

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2023-03-29

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..

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Detailed Description

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Conditions

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Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes measures will be collected electronically

Study Groups

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Experimental - Cogito Companion

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.

Group Type EXPERIMENTAL

Experimental - Cogito Companion

Intervention Type DEVICE

Cogito Companion

Active Control

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 .

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

Use of MyCAP

Interventions

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Experimental - Cogito Companion

Cogito Companion

Intervention Type DEVICE

Active Control

Use of MyCAP

Intervention Type BEHAVIORAL

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes