| Methods |
RCT |
| Participants |
People with major depression recruited through television, radio and newspaper. Mean age 52 (SD 8), 76% women, N = 202 |
| Interventions |
1. Home‐based aerobic exercise (same 'exercise prescription' as the supervised aerobic group, but performed it on their own (n = 53)
2. Supervised group aerobic exercise (walking and jogging) (n = 51)
3. Sertraline (n = 49)
4. Placebo (n = 49)
Intervention 16 weeks |
| Outcomes |
Primary endpoint was remission (no MDD) and a HAM score of < 8, and also a continuous severity score on the HAM‐D |
| Notes |
Analysis intention‐to‐treat using last observation carried forward
Blinded outcome assessment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Conditional randomisation, stratified by age, gender and depression severity |
| Allocation concealment (selection bias) |
Low risk |
Central allocation by a computer |
| Blinding (performance bias and detection bias)
participants |
Unclear risk |
Participants were aware of whether they received exercise or not. It is unclear whether this introduced bias |
| Blinding (performance bias and detection bias)
those delivering intervention |
Unclear risk |
Those personnel delivering exercise were aware of group allocation. It is unclear whether this introduced bias |
| Blinding (performance bias and detection bias)
outcome assessors |
Low risk |
The outcome assessors were unaware of treatment allocation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Imputed missing outcome assessment results by last observation carried forward |
| Selective reporting (reporting bias) |
Low risk |
From the study report, it appears that all the prespecified outcome measures have been reported. Authors report protocol on clinicaltrials.gov |
| Other bias |
Unclear risk |
Unclear |
