Facilitating Assessment of At-Risk Sailors Using Technology

Psychological Distress Clinical Trial

— FAAST  

Official title:

Facilitating Assessment of At-Risk Sailors Using Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159480
• Other study ID #: 18-2844
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: March 29, 2023

Study information

• Verified date: May 2023
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Device:
• Experimental - Cogito Companion
Cogito Companion

Behavioral:
• Active Control
Use of MyCAP

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System	Military Suicide Research Consortium, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive Symptoms	Changes on the Patient Health Questionnaire-9	After the 3 month interventional period
Other	Post Traumatic Symptoms	Changes on the PTSD Checklist for DSM-5	After the 3 month interventional period
Other	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
Primary	Psychological Distress	Outcome Questionnaire-45	After the 3 month interventional period
Secondary	Time to Treatment Engagement During Study Period	Review of Electronic Medical Records and Self Report	After the 3 month interventional period
Secondary	Number of Treatment Sessions Attended	Review of Electronic Medical Record and Self Report	After the 3 month interventional period