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OpenTrials
Completed

NCT Number: NCT04159480

Facilitating Assessment of At-Risk Sailors Using Technology

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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Key information

Conditions

Psychological Distress

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental - Cogito Companion

Device

Cogito Companion

Active Control

Behavioral

Use of MyCAP

Primary outcomes

  1. Percentage of Cogito Participants Reported Being Satisfied

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Collaborators

  • Military Suicide Research Consortium
  • University of Colorado, Denver

Registry information

Acronym: FAAST

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 12, 2019
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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