Sumaya 2001.
Methods | Design: three group, three period, cross‐over trial Purpose: examine the effect of bright light treatment on depression in institutionalised older adults | |
Participants | Patients: institutionalised older adults with moderate to severe depression (baseline scores on the Geriatric Depression Scale 11 to 20) Baseline comparability: not relevant |
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Interventions | Placebo: sessions with light treatment with 300 Lux for 30 minutes per day for 1 week Untreated: no light treatment Experimental: light treatment with 10,000 Lux (Co‐intervention: NS) | |
Outcomes | Geriatric Depression Scale at day 5 of each treatment period | |
Notes | The outcome data was not available from the first period only, and was calculated as deriving from a parallel group trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | NS |
Allocation concealment? | Unclear risk | NS |
Blinding? Treatment provider | Unclear risk | NS |
Blinding? Outcome assessor | Unclear risk | NS |
Incomplete outcome data addressed? All outcomes | Low risk | Drop‐out < 15% |
Free of selective reporting? | Unclear risk | No protocol available |
Free of other bias? | Unclear risk | The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
No signs of variance inequality or skewness? | Low risk | No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
Trial size > 49? | High risk | N = 20 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% | High risk | Trial size < 49 |