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:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-25 @ 4:13 PM
NCT ID:
NCT05805657
Description:
Providers treated patients who could have been in either the immediate or UC-DT conditions. Therefore, we analyzed by collapsing across immediate and UC-DT for providers.
Frequency Threshold:
0
Time Frame:
Through study completion, an average of 12 months.
Study:
NCT05805657
Study Brief:
Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 2: Train-the-Trainer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard TranS-C (Immediate) | Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted. Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation. Participants in this group received Standard TranS-C immediately. | 0 | None | 0 | 8 | 0 | 8 | View |
| Adapted TranS-C (Immediate) | Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context. The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions. Participants in this group received Adapted TranS-C immediately. | 0 | None | 0 | 70 | 0 | 70 | View |
| Adapted TranS-C (UC-DT) | Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Adapted TranS-C. | 0 | None | 0 | 57 | 0 | 57 | View |
| Standard TranS-C - Providers | Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation. These data reflect the characteristics of providers who delivered Standard TranS-C. | 0 | None | 0 | 6 | 0 | 6 | View |
| Adapted TranS-C - Providers | The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions. These data reflect the characteristics of providers who delivered Adapted TranS-C. | 0 | None | 0 | 47 | 0 | 47 | View |
| Standard TranS-C (UC-DT) | Usual Care Delayed Treatment. Usual care in the partner CMHCs starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring). Participants in this group received usual care followed by delayed treatment with Standard TranS-C. | 0 | None | 0 | 8 | 0 | 8 | View |
Serious Events(If Any):
Other Events(If Any):