Comparison · NCT02655354-sae
Intervention vs Usual Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Intervention vs Usual Care: serious adverse events. Trial comparisons, record NCT02655354-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02655354-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0566 | 0.0346 | 0.0913 | wilson | |
| Risk in group 2 | 0.0351 | 0.0206 | 0.0592 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0215 | -0.0111 | 0.059 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.61 | 0.78 | 3.33 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 0.771 | 3.52 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intervention than on Usual Care | 46.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention | The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.~Motivational Interviewing~Cognitive Behavioral Therapy Elements~Care Management~Fluoxetine: Anti-depressant~Fluvoxamine: Anti-depressant~Paroxetine: Anti-depressant~Sertraline: Anti-depressant~Citalopram: Anti-depressant~Venlafaxine: Anti-depressant~Duloxetine: Anti-depressant~Mirtazapine: Anti-depressant~Diphenhydramine: Sleep medication~Trazodone: Sleep medication~Prazosin: Sleep medication | 15 | 265 | EG000 |
| Group 2 | Usual Care | Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject. | 13 | 370 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline, 3 Month, 6 Month, and 12 Month
Source ClinicalTrials.gov
Trial
- Title
- A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
- NCT number
- NCT02655354
- Phases
- NA
- Conditions
Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life, Pain, Wounds and Injury, Brain Injuries, Chronic Disease
- Interventions
Motivational Interviewing, Cognitive Behavioral Therapy Elements, Care Management, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Citalopram, Venlafaxine, Duloxetine, Mirtazapine, Diphenhydramine, Trazodone, Prazosin
- Lead sponsor
- University of Washington
- Results first posted
- 2021-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02655354?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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