Blumenthal 2012a.
Methods | RCT | |
Participants | 35 years or older with documented coronary artery disease and depressive symptoms (n=101) | |
Interventions | 1. Exercise (group walking, running or jogging on treadmill (n = 37; 65% men) 2. Sertraline (n = 40; 63% men) 3. Placebo (n = 24; 83% men) |
|
Outcomes | Depression as diagnosed by DSM‐IV and severity of depression as rated on HAM‐D; heart disease biomarkers | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐based randomisation |
Allocation concealment (selection bias) | Low risk | Allocation through distribution of sealed envelopes |
Blinding (performance bias and detection bias) participants | Unclear risk | Not possible to blind participants receiving exercise; unclear effect on bias |
Blinding (performance bias and detection bias) those delivering intervention | Unclear risk | No detail given |
Blinding (performance bias and detection bias) outcome assessors | Low risk | Telephone surveys (HAMD) by psychologists blinded to arm of trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 95 out of 101 completed protocol and outcome assessment |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported in results. There is a study protocol |
Other bias | Unclear risk | Unclear |