Psychological Distress
Conditions
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..
Interventions
DEVICEExperimental - Cogito Companion
Cogito Companion
BEHAVIORALActive Control
Use of MyCAP
Sponsors
VA Eastern Colorado Health Care System
University of Colorado, Denver
Military Suicide Research Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes measures will be collected electronically
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cogito Participants Reported Being Satisfied | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Brenner, Ph.D.
VA/University of Colorado
Participant flow
Recruitment details
279 Naval personnel were enrolled and randomized - 139 participants to Cognito Companion and 140 to Active Control
Participants by arm
| Arm | Count |
|---|---|
| Cogito Randomized to Cogito | 139 |
| Active Control Randomized to Control | 140 |
| Total | 279 |
Baseline characteristics
| Characteristic | Active Control | Cogito | Total |
|---|---|---|---|
| Age, Continuous | 28.3 Years STANDARD_DEVIATION 6.7 | 28.7 Years STANDARD_DEVIATION 6.8 | 28.5 Years STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 11 Participants | 7 Participants | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 22 Participants | 26 Participants | 48 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian/White | 82 Participants | 89 Participants | 171 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Declined to Answer | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiple Races | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American/Alaskan | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 9 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Ranomized to Cogito or Active Control | 140 Participants | 139 Participants | 279 Participants |
| Sex/Gender, Customized Gender Declined | 3 Participants | 2 Participants | 5 Participants |
| Sex/Gender, Customized Gender Female | 28 Participants | 28 Participants | 56 Participants |
| Sex/Gender, Customized Gender Male | 109 Participants | 109 Participants | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 140 |
| other Total, other adverse events | 0 / 139 | 0 / 140 |
| serious Total, serious adverse events | 0 / 139 | 0 / 140 |
Outcome results
Primary
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.
Time frame: From Baseline to Follow-Up, Approximately 3 months
Population: Participant Satisfaction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cogito | Percentage of Cogito Participants Reported Being Satisfied | 52 percentage of participants |