ENRICHD 2003.
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 2481 Length of follow‐up: Evaluations after 6 months and annually thereafter (follow‐up duration 18 to 54 months) Analysis: Intention‐to‐treat (93 treatment patients did not receive intervention) |
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| Participants | Location: USA Number of study centres and setting: Outpatients from 73 hospitals affiliated with 8 clinical centres CAD criteria: Acute myocardial infarction (MI) with elevation in one or more biomarker as well as MI‐compatible symptoms or characteristic ECG ST‐T changes or new Q waves; randomisation within 28 days after MI Depression criteria: Major depression or dysthymia diagnosis based on the Depression Interview and Structured Hamilton (DISH) according to modified DSM‐IV criteria Other entry criteria: Low perceived social support assessed through the ENRICHD Social Support Instrument (ESSI) Exclusion criteria: Patients with acute MI following Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), receiving psychotherapy or taking an antidepressant for longer than 14 days but remained depressed, noncardiac conditions likely to be fatal within 1 year, too ill to participate, participating in another trial, major psychiatric disorder (including schizophrenia, bipolar disorder, severe dementia, or active substance abuse), at risk for suicide, refusal of participation or physician disallowed participation, could not be enrolled within 28 days, inaccessible for intervention or follow‐up Treatment: 1238 (43% female, mean age: 61 (SD: 12.6)) Control: 1243 (44% female, mean age: 61 (SD: 12.5)) Comparability of groups: No significant baseline differences except for the use of angiotensin‐converting enzyme (ACE) inhibitors |
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| Interventions | Treatment: Individual (at least 6 1‐hour sessions weekly) and group (weekly 2‐hour sessions) Cognitive Behavior Therapy (CBT) by Beck supplemented with techniques based on social learning theory for patients with low perceived social support; patients with scores >24 on the Hamilton Rating Scale for Depression (HAM‐D) or those with less than 50% reduction in Beck Depression Inventory (BDI) score after 5 weeks referred to study psychiatrist for consideration of pharmacotherapy with sertraline (50 to 200 mg/d) Control: Usual care Duration of treatment: Individual behavioral intervention up to 6 months with additional 12 weeks for group therapy, adjunctive pharmacotherapy up to 12 months |
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| Outcomes | Review outcomes: Combined end point of all‐cause mortality and nonfatal reinfarction, all‐cause mortality, cardiovascular mortality, revascularization procedures, cardiovascular hospitalizations, depression (change in HRSD and BDI scores from baseline to 6 months), health‐related quality of life (SF‐12 PCS and MCS) Other outcomes: Social support and social networks, life satisfaction, change in cardiac risk factor profile, perceived stress, self‐efficacy |
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| Funding | National Heart, Lung, and Blood Institute; Pfizer Inc. | |
| Notes | Mixed study sample (patients with depression and/or low perceived social support were enrolled) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: Automated telephone randomization system using permuted blocks with varying sizes, stratified by clinical center; test for selection bias potentially resulting from unmasking of previous assignments (participants and interventionists were unblinded) with nonsignificant results |
| Allocation concealment (selection bias) | Low risk | Comment: Allocation obtained by an automated telephone randomization system |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: Participants and interventionists unmasked Quote: "Staff who collected, verified, or classified end point data or follow‐up assessments were masked as much as possible" (Berkman, 2003). Quote: "End point data collection, verification and classification, and follow‐up psychosocial assessments are conducted by staff who are blinded to treatment assignment." (Hoskings, 2000) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Depression outcomes analysed per protocol, all other outcomes ITT |
| Selective reporting (reporting bias) | High risk | Comment: Results of all main outcomes reported as described in the design papers of the trial except for change in cardiac risk factor profile, perceived stress and self‐efficacy |
| Other bias | High risk | Comment: Therapy quality and adherence to treatment protocol were monitored by the Beck Institute Comment: QoL was not assessed at baseline and it thus remains unclear whether or not QoL was balanced in the two groups at baseline Comment: Conflicting interests: Funded by Pfizer (Inc.) |