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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Book Club Active Control | The subject will participate in 16 hours that are broken into sessions for the book club active control intervention. This club will be facilitated by 1-2 instructors. The club will be described as a "fun activity to do outside of work to help reduce work-related stress." The club will be structured similarly to the intervention with respect to time, and homework expectations. Nurses will be prohibited from talking about work stress. Book Club Active Control Intervention: Participants randomized to the book club active control intervention will meet for 16 hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention. | 0 | None | 0 | 58 | 0 | 58 | View |
| MBCT Intervention | The subject will participate in 16 hours that are broken into sessions for the Mindfulness-Based Cognitive Therapy intervention. The intervention will be facilitated by 1-2 instructors who are trained in clinical psychology/ social work and are also trained in MBCT. This intervention will include mindfulness activities, didactic learning, homework assignments and group dialogue. This adapted MBCT intervention will follow the empirically-based MBCT intervention for depression structure with fidelity. Mindfulness-Based Cognitive Therapy: Mindfulness-Based Cognitive therapy is a 16 hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores. | 0 | None | 0 | 48 | 0 | 48 | View |