NCT04159480

Facilitating Assessment of At-Risk Sailors Using Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: VA Eastern Colorado Health Care System · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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..

Conditions

• Psychological Distress

Interventions

Type	Name	Description
DEVICE	Experimental - Cogito Companion	Cogito Companion
BEHAVIORAL	Active Control	Use of MyCAP

Timeline

• Start date: 2019-12-09
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2019-11-12
• Last updated: 2026-03-02
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study