Facilitating Assessment of At-Risk Sailors Using Technology (FAAST)

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..

Study Overview

• Status: Completed
• Conditions: Psychological Distress
• Intervention / Treatment: Device: Experimental - Cogito Companion; Behavioral: Active Control

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Experimental - Cogito Companion; Cogito Companion
Active Comparator: 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 .	Behavioral: Active Control; Use of MyCAP

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Changes on the Patient Health Questionnaire-9	After the 3 month interventional period
Post Traumatic Symptoms	Changes on the PTSD Checklist for DSM-5	After the 3 month interventional period
Suicidal Ideation	Changes on the Beck Suicide Ideation Scale and Columbia-Suicide Severity Rating Scale Screener; C-SSRS Screener	After the 3 month interventional period

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Collaborators: University of Colorado, Denver; Military Suicide Research Consortium
• Investigators: Principal Investigator: Lisa Brenner, Ph.D., VA/University of Colorado

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-2844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No