Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
NCT ID:
NCT04507360
Description:
None
Frequency Threshold:
0
Time Frame:
Study 1: Adverse events were collected for the entirety of time users spent in a single session while using the Mental Health America (MHA) website, from the time that they entered the MHA website to the time that they exited the website, or when their session ended. Adverse events were collected throughout the entirety of the study's 3-month duration. Study 2: Adverse events were collected for the entirety of time patients were in the study from baseline to 8 week follow-up.
Study:
NCT04507360
Study Brief:
Enhancing Engagement With Digital Mental Health Care
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Study 1, Demographic Survey | This arm included participants who were randomized to the Demographics Survey (stage 1 randomization) and were not randomized to a stage 2 condition (i.e., did not view screening results page on which stage 2 randomization occurred). | 0 | None | 0 | 2490 | 0 | 2490 | View |
| Study 1, Next Steps Survey | This arm included participants who were randomized to the Next Steps Survey (stage 1 randomization) and were not randomized to a stage 2 condition (i.e., did not view screening results page on which stage 2 randomization occurred). | 0 | None | 0 | 2367 | 0 | 2367 | View |
| Study 1, Demographic Survey + Generic Response + Generic Resources | This arm included participants who completed the Demographics Survey (stage 1 randomization). The Generic Response + Generic Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and the four generic resource pages on MHA's website. | 0 | None | 0 | 19250 | 0 | 19250 | View |
| Study 1, Next Steps Survey + Generic Response + Tailored Resources by Desired Resources | This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Generic Response + Tailored Resources by Desired Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and 4 resources tailored to a survey question that asks participants what they would like to do next on the website after screening is complete (e.g., "Learn more about depression", "Take another mental health test") | 0 | None | 0 | 8636 | 0 | 8636 | View |
| Study 1, Next Steps Survey + Tailored Response + Generic Resources | This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Tailored Response + Generic Resources condition (stage 2 randomization) will feature a response tailored to screening status (above or below criteria for depression) and expressed need for mental health support (e.g., "We're so glad to hear you're open to exploring how to improve your mental health. People who score with minimum or mild depression often notice that symptoms can get worse in the weeks after taking a Depression test.") They will also receive the 4 generic resources. | 0 | None | 0 | 8454 | 0 | 8454 | View |
| Study 1, Next Steps Survey + Tailored Response + Tailored Resources by Desired Resources | This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Tailored Response + Tailored Resources by Desired Resources condition (stage 2 randomization) will feature a response tailored to screening status (above or below criteria for depression) and expressed need for mental health support, and will receive resources tailored to a survey question that asks participants what they would like to do next on the website after screening is complete (e.g., "Learn more about depression", "Take another mental health test"). | 0 | None | 0 | 8371 | 0 | 8371 | View |
| Study 2, Control | Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY) and will receive surveys from W1 to W4 and follow-up surveys in W5 and at the end of W8. Study 2, Control: Participants in the Do-It-Yourself (DIY) control group will receive psychoeducation materials in W0. They will view content as usual (no DIY). | 0 | None | 0 | 269 | 0 | 269 | View |
| Study 2, DIY Tool Without AI | Participants in the Do-It-Yourself (DIY) tool without Artificial Intelligence (AI) group will be instructed to use the DIY tool 3 times a week. They will receive surveys from W1 to W4 and follow-up surveys in W5 and at the end of W8. Study 2, DIY tool without AI: Participants in the Do-It-Yourself (DIY) tool without Artificial Intelligence (AI) group will be instructed to use the DIY tool 3 times a week. | 0 | None | 0 | 272 | 0 | 272 | View |
| Study 2, DIY Tool With AI | Participants in the Do-It-Yourself (DIY) tool with Artificial Intelligence (AI) group will be instructed to use the DIY tool with AI 3 times a week. They will receive surveys from W1 to W4 and follow-up surveys in W5 and at the end of W8. Study 2, DIY tool with AI: Participants in the Do-It-Yourself (DIY) tool with Artificial Intelligence (AI) group will be instructed to use the DIY tool with AI 3 times a week. | 0 | None | 0 | 298 | 0 | 298 | View |
| Study 1, Demographic Survey + Generic Response + Tailored Resources by Demographics | This arm included participants who completed the Demographics Survey (stage 1 randomization). The Generic Response + Tailored Resources by Demographics condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and resources tailored to two demographics. People who endorse being Lesbian, Gay, Bisexual, Transgender, or Queer (LGBTQ) will receive 4 resources associated with LGBTQ issues. People who endorse being 8-17, 18-24, 25-44, or 45+ years of age will receive 4 resources used by people in those age groups. If someone enters both age and LGBTQ status, they will be provided with 2 resources tailored to age and 2 resources tailored to LGBTQ status, randomly chosen. | 0 | None | 0 | 19240 | 0 | 19240 | View |
| Study 1, Next Steps Survey + Generic Response + Generic Resources | This arm included participants who completed the Next Steps Survey (stage 1 randomization). The Generic Response + Generic Resources condition (stage 2 randomization) will feature the response-as-usual on Mental Health America (MHA)'s website and the four generic resource pages on MHA's website. | 0 | None | 0 | 8743 | 0 | 8743 | View |
Serious Events(If Any):
Other Events(If Any):