Stotts 2006.
Methods | Pilot RCT. | |
Participants | 31 male treatment‐seeking cocaine abusers. USA. | |
Interventions | Two‐session MI intervention with informative biological EEG/ERP feedback (n=17) or a minimal control condition who had two brief meetings with an experienced research assistant weekly over two weeks (n=14). | |
Outcomes |
Physiological primary: Cocaine‐positive urine screens. Non‐physiological primary: Proportion of self‐reported cocaine use days. Secondary: Readiness to change (URICA). Data not reported. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomised". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Patients and providers | Low risk | No blinding, but most outcomes were physiological and also used to validate self‐reports, and not likely to be influenced by lack of blinding. |
Blinding (performance bias and detection bias) Assessors | Low risk | "Posttreatment assessment was conducted at 1‐week post‐study by clinic staff blind to study condition." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Only subjects with data at both time points were analysed (27/31 = 13% attrition). Reasons for missing data not reported. ITT not performed. |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the study hypotheses. |
Other bias | Low risk | EEG screening to validate self‐report. There were no differences between groups at baseline. No additional sources of bias appear to be present. |