Psychological DistressFAASTNCT04159480
Facilitating Assessment of At-Risk Sailors Using Technology
A study testing Experimental - Cogito Companion in people with Psychological Distress, run by VA Eastern Colorado Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Experimental - Cogito Companion
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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..
- Conditions
- Psychological Distress
- Being tested
- Experimental - Cogito Companion, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental - Cogito CompanionDevice
Cogito Companion
Active ControlBehavioural
Use of MyCAP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Follow-Up, Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start9 Dec 2019
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver, Military Suicide Research Consortium
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa Brenner, Ph.D., Principal investigator, VA/University of Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159480
- Sponsor's protocol ID
- 18-2844
- Acronym
- FAAST
- Status last verified
- Feb 2026
- First submitted
- 30 Oct 2019
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Assessment of At-Risk Sailors Using Technology
- ClinicalTrials.gov ID
- NCT04159480
- Acronym / sponsor ID
- FAAST / 18-2844
- Conditions
- Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- University of Colorado, Denver, Military Suicide Research Consortium
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental - Cogito Companion | Experimental | Device: Experimental - Cogito CompanionThose 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. |
| Active Control | Active comparator | Behavioral: Active ControlParticipants 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 . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental - Cogito CompanionCogito Companion | Device | Experimental - Cogito Companion |
| Active ControlUse of MyCAP | Behavioural | Active Control |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Brenner, Ph.D. principal investigator
VA/University of Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental - Cogito Companion in people with Psychological Distress, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cogito Participants Reported Being Satisfied (time frame: From Baseline to Follow-Up, Approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.