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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159480
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : December 24, 2019
Sponsor:
Collaborators:
University of Colorado - Anschutz Medical Campus
Military Suicide Research Consortium
Information provided by (Responsible Party):
Lisa Brenner, 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..

Condition or disease Intervention/treatment Phase
Psychological Distress Device: Experimental - Cogito Companion Behavioral: Active Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes measures will be collected electronically
Primary Purpose: Health Services Research
Official Title: Facilitating Assessment of At-Risk Sailors Using Technology
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : March 29, 2021
Estimated Study Completion Date : March 29, 2021

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




Primary Outcome Measures :
  1. Psychological Distress [ Time Frame: After the 3 month interventional period ]
    Outcome Questionnaire-45


Secondary Outcome Measures :
  1. Time to Treatment Engagement During Study Period [ Time Frame: After the 3 month interventional period ]
    Review of Electronic Medical Records and Self Report

  2. Number of Treatment Sessions Attended [ Time Frame: After the 3 month interventional period ]
    Review of Electronic Medical Record and Self Report


Other Outcome Measures:
  1. Depressive Symptoms [ Time Frame: After the 3 month interventional period ]
    Changes on the Patient Health Questionnaire-9

  2. Post Traumatic Symptoms [ Time Frame: After the 3 month interventional period ]
    Changes on the PTSD Checklist for DSM-5

  3. Suicidal Ideation [ Time Frame: After the 3 month interventional period ]
    Changes on the Beck Suicide Ideation Scale and Columbia-Suicide Severity Rating Scale Screener; C-SSRS Screener



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159480


Contacts
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Contact: Kelly Stearns-Yoder, MA 729-723-6477 Kelly.Stearns@va.gov
Contact: Lisa Brenner, Ph.D. 720-878-2243 lisa.brenner@va.gov

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Lisa Brenner, Ph.D.    303-724-4588    lisa.2.brenner@cuanschutz.edu   
Contact: Kelly Stearns    (720 ) 723-6477    kelly.stearns@va.gov   
Sponsors and Collaborators
VA Eastern Colorado Health Care System
University of Colorado - Anschutz Medical Campus
Military Suicide Research Consortium
Investigators
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Principal Investigator: Lisa Brenner, Ph.D. VA/University of Colorado
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Responsible Party: Lisa Brenner, Director, Rocky Mountain MIRECC, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT04159480    
Other Study ID Numbers: 18-2844
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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