Doering 2007.
| Methods | RCT design: 2‐arm parallel group trial Total N randomised: Not stated Length of follow‐up: 4 months Analysis: Per‐protocol |
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| Participants | Location: USA Number of study centres and setting: 2 urban medical centres CAD diagnosis: Patients undergoing first‐time Coronary Artery Bypass Grafting (CABG); time to randomization not specified Depression diagnosis: Patients with Mini‐Mental State Examination (MMSE) score of >= 24 were interviewed with the Diagnostic Interview and Structured Hamilton (DISH); diagnosis of major depression during inpatient treatment or 2 to 4 weeks after hospital admission or minor depression at both interviews Other entry criteria: <=75 years, English‐speaking, available for 6 months follow‐up Exclusion criteria: Malignancies or autoimmune disorders Treatment N: 7 (100% female, mean age: 58.6 (SD: 7.6)) Control N: 8 (100% female, mean age: 60.9 (SD: 9.4)) Comparability of groups: Treatment patients with a significantly higher rate of depression history |
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| Interventions | Treatment: Cognitive Behavioral Therapy (weekly 1‐hour sessions) by a trained nurse therapist including establishing therapeutic relationship, behavioral activation, active problem‐solving, identification of automatic thoughts, reframing automatic thoughts, learning self‐therapy and relapse prevention Control: Usual care comprising usual medical and nursing follow‐up after CABG and an assessment by a psychiatrist who recommended individualised treatment options Duration of treatment: 8 weeks |
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| Outcomes | Review outcomes: Beck Depression Inventory (BDI) score Other outcomes: Postoperative illnesses measured by a Modified Health Review (MHR), Natural killer cell cytotoxicity (NK cytotoxicity), Interleukin (IL‐6), C‐reactive protein (CRP) |
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| Funding | Not stated | |
| Notes | Study investigated depressed post‐CABG women | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: No details reported |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: Outcome assessed by a blinded research assistant |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Only those patients who completed all study measures were included in this report." (p. 19) |
| Selective reporting (reporting bias) | Unclear risk | Comment: Outcomes reported as stated in the methods section Comment: No protocol or design paper available |
| Other bias | Unclear risk | Comment: No efforts regarding nurse therapists protocol adherence reported Comment: Usual care comprised psychiatrists' recommendations for individualised treatment options, but utilised treatments of control patients were not assessed |