Facilitating Assessment of At-Risk Sailors Using Technology

Not Applicable

Completed

• Conditions: Psychological Distress
• Interventions: Device: Experimental - Cogito Companion; Behavioral: Active Control

• Registration Number: NCT04159480
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief 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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Study Start: 2019-12-09
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Results First Submitted: 2024-04-23
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Results First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental - Cogito Companion	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.
Active Control	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 .

Primary Outcome Measures

Name	Time	Method
Percentage of Cogito Participants Reported Being Satisfied	From Baseline to Follow-Up, Approximately 3 months	To measure the percentage of participants randomized to Cogito who were satisfied, a 'Client Satisfaction Questionnaire' was distributed to participants to complete and return. Responses were collected and evaluated to find the percentage of participant satisfaction.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States