NCT04159480

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 9, 2025

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

October 30, 2019

Results QC Date

April 23, 2024

Last Update Submit

February 17, 2026

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (1)

  • Percentage of Cogito Participants Reported Being Satisfied

    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.

    From Baseline to Follow-Up, Approximately 3 months

Study Arms (2)

Experimental - Cogito Companion

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

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

Interventions

Experimental - Cogito CompanionDEVICE

Cogito Companion

Experimental - Cogito Companion
Active ControlBEHAVIORAL

Use of MyCAP

Active Control

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

Title
Lisa Brenner
Organization
University of Colorado, Anschutz Medical Campus
lisa.2.brenner@cuanschutz.edu
7208481980

Study Officials

  • Lisa Brenner, Ph.D.

    VA/University of Colorado

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes measures will be collected electronically
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 12, 2019

Study Start

December 9, 2019

Primary Completion

March 29, 2023

Study Completion

March 29, 2023

Last Updated

March 2, 2026

Results First Posted

May 9, 2025

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)