Comparison · NCT01032018-sae
Referred Care vs Stepped 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. Referred Care vs Stepped Care: serious adverse events. Trial comparisons, record NCT01032018-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01032018-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 | 0.104 | 0.0536 | 0.192 | wilson | |
| Risk in group 2 | 0.0959 | 0.0472 | 0.185 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00801 | -0.0943 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.414 | 2.84 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.375 | 3.18 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Referred Care than on Stepped Care | 125 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Referred Care | The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist. | 8 | 77 | EG000 |
| Group 2 | Stepped Care | The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen. | 7 | 73 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2, 4, and 6 months after enrollment
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Depression Interventions After Acute Coronary Syndrome
- NCT number
- NCT01032018
- Phases
- PHASE1, PHASE2
- Conditions
- Acute Coronary Syndrome, Depression
- Interventions
- Problem Solving Therapy, Sertraline, citalopram, or bupropion, Standard care
- Lead sponsor
- Columbia University
- Results first posted
- 2014-08-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01032018?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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