Doering 2007.
| Study characteristics | ||
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: not stated Length of follow‐up: 4 months Analysis: per‐protocol (number of participants who dropped out of nested trial unclear; 23 participants did not finish study) |
|
| Participants | Location: USA Number of study centres and setting: 2 urban medical centres CAD criteria: patients undergoing first‐time CABG; time to randomisation not specified Depression criteria: diagnosis of major depression during inpatient treatment or 2 to 4 weeks after hospital admission or minor depression at both interviews diagnosed by the Diagnostic Interview and Structured Hamilton (DISH) Other entry criteria: <= 75 years old, English‐speaking, Mini‐Mental State Examination score of >= 24, 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 group participants had a significantly higher rate of depression history |
|
| Interventions | Treatment: CBT (weekly 1‐hour sessions) by a trained nurse therapist including establishing therapeutic relationship, behavioural 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 |
|
| Outcomes | Review outcomes: depression symptoms (BDI), depression disorders (DISH), postoperative illnesses (Modified Health Review) Other outcomes: biomarkers (natural killer cell cytotoxicity, interleukin‐6, C‐reactive protein) |
|
| Funding | Not stated | |
| Notes | Study investigated depressed post‐CABG women; intervention trial was nested in a study inclusive of a non‐depressed comparator group. | |
| 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 of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: Outcome assessed by a research assistant blinded to allocation |
| 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: depression disorders were assessed at follow‐up (DISH) and this data was not reported for intervention and control group who all met criteria for baseline depression disorder. No protocol or design paper available |
| Other bias | Unclear risk | Comment: No efforts regarding nurse therapists protocol adherence reported. Usual care comprised psychiatrists' recommendations for individualised treatment options, but utilised treatments in the control group were not assessed |