Design and Rationale for a Randomized, Controlled Trial of Interpersonal Psychotherapy and Citalopram for Depression in Coronary Artery Disease (CREATE)
Bibliographic record
Abstract
Objective: Recognition that depression is associated with increased morbidity and mortality in coronary artery disease (CAD) patients has augmented the need for evidence-based treatment guidelines. This article presents the design of a multisite, Canadian trial of the efficacy, safety, and tolerability of interpersonal psychotherapy (IPT), an empirically supported, depression-focused therapy, and the selective serotonin reuptake inhibitor citalopram, alone or in combination, in the treatment of major depression in CAD patients. Methods: Two hundred eighty stable CAD patients with a current major depressive episode of at least 4 weeks’ duration, based on the Structured Clinical Interview for Depression (SCID), and who have a baseline score >19 on a centralized, telephone-administered, 24-item Hamilton Depression Rating Scale (HAM-D) will be randomly assigned to receive 12 weekly IPT sessions or 12 weekly sessions of standardized clinical management (CM). Patients are also randomly assigned to receive 20 to 40 mg per day of citalopram or pill-placebo. This results in a 2-by-2 factorial design with four groups: IPT plus pill-placebo, IPT plus citalopram, CM plus pill-placebo, and CM plus citalopram. This permits the evaluation of both IPT and citalopram. Blinded, centralized, 24-item, HAM-D telephone ratings constitute the primary outcome variable. The self-report Beck Depression Inventory-II is the secondary outcome. Analyses will involve the intent-to-treat principle with last observation carried forward for incomplete assessments. Results: Not applicable. Conclusions: The results of this trial will contribute to the development of evidence-based clinical guidelines for managing depression in the context of CAD. CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy; IPT = interpersonal psychotherapy; CAD = coronary artery disease; SCID = Structured Clinical Interview for Depression; HAM-D = Hamilton Depression Rating Scale; CM = clinical management; SADHART = Sertraline Antidepressant Heart Attack Randomized Trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease; SSRI = selective serotonin reuptake inhibitor; ECG = electrocardiogram; NIMH = National Institute of Mental Health; TDCRP = Treatment of Depression Collaborative Research Program; MMSE = Mini-mental Status Exam; STAR*D = Sequenced Treatment Alternatives to Relieve Depression; IDS = Inventory for Depressive Symptomatology; BDI-II = Beck Depression Inventory-II; IPRI = Interpersonal Relationship Inventory; FPI = Functional Performance Inventory; SAE = serious adverse event; LOCF = last observation carried forward; DSMB = data safety monitoring board.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".