Kay‐Lambkin 2009.
Methods | RCT | |
Participants | 97 Australian people with comorbid major depression and alcohol/cannabis misuse. | |
Interventions | Brief intervention for depressive symptoms followed by randomisation into 3 different groups: 1. therapist‐delivered MI/CBT (n= 35) 2. computer‐delivered MI/CBT (n= 32) 3. no further treatment (n= 30) |
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Outcomes | Alcohol/cannabis use and hazardous substance use index scores measured at baseline, and 3, 6 and 12 months post‐baseline assessment using the Opiate Treatment Index (OTI) and the SCID‐RV. | |
Notes | In one condition, MI/CBT was delivered by computer (not considered in this review). Intervention is called SHADE therapy (Self‐Help for Alcohol and other drug use and Depression). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A permuted block randomisation approach was used so that the distribution of participants across treatment conditions could be maintained regardless of the final sample size." |
Allocation concealment (selection bias) | Low risk | "Treatment allocations were transferred from this list by an administrative assistant and concealed in individual envelopes labelled with the relevant participant code. Neither of these processes was conducted by personnel involved with the assessment or treatment phases of the study. Prior to the BI session, the research clinicians were issued with a new randomisation envelope by the administrative assistant, which displayed the participant number on the outside of the envelope with the treatment allocation sealed inside. The envelope was opened by the participant at the conclusion of the BI session." |
Blinding (performance bias and detection bias) Patients and providers | High risk | Patients and providers were not blinded. |
Blinding (performance bias and detection bias) Assessors | Low risk | "At the conclusion of the treatment period all participants, regardless of treatment completion, met with an independent research clinician, blind to treatment allocation, to complete follow‐up assessments." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was 16% at 3 months follow‐up, 19% at 6 months, and 16% at 12 months. Reasons provided. Not stated whether attrition was balanced. ITT was performed. |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes based on the study hypotheses. |
Other bias | Unclear risk | Only self‐reported outcomes. Differences between groups at baseline were not fully reported. Age and gender were similar. No additional sources of bias appear to be present. |