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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Military Suicide Research Consortium | OTHER |
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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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental - Cogito Companion | Device | Cogito Companion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria.
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Brenner, Ph.D. | VA/University of Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
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279 Naval personnel were enrolled and randomized - 139 participants to Cognito Companion and 140 to Active Control
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Experimental - Cogito Companion: Cogito Companion |
| FG001 | 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 . Active Control: Use of MyCAP |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Cogito | Randomized to Cogito |
| BG001 | Active Control | Randomized to Control |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participant Satisfaction | Posted | Number | percentage of participants | From Baseline to Follow-Up, Approximately 3 months |
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From Baseline to Follow-Up, Approximately 3 Months
All cause death and serious adverse event related to study participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cogito | Adverse events for Cogito group. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Brenner | University of Colorado, Anschutz Medical Campus | 7208481980 | lisa.2.brenner@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2021 | Apr 15, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2023 | Apr 15, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2019 | Feb 17, 2026 | ICF_004.pdf |
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Randomized Clinical Trial
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Outcomes measures will be collected electronically
| Active Control |
| Behavioral |
Use of MyCAP |
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| Total |
Total of all reporting groups |
| Years |
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| Sex/Gender, Customized | Gender of Participants | Evaluated characteristic by group | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Ranomized to Cogito or Active Control | Count of Participants | Participants |
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|
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| 139 |
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | Active Control | Adverse events for Active Control group. | 0 | 140 | 0 | 140 | 0 | 140 |
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