Rosenblum 2014.
Methods | Allocation: randomised. Design: multiple sites. Duration: 3 and 6 months. Setting: outpatient and residential. Location: Grand Rapids, MI and New York, NY, USA. |
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Participants | Diagnosis: serious mental illness (major depression, bipolar disorder, N = 97 and schizophrenia, N = 59) and lifetime history of substance misuse determined by Modified Simple Screening instrument for Substance Abuse. N = 203. Age: 42 years. Sex: 138 M, 65 F. Ethnicity: Hispanic (13%), Black (32%) white (52%), other (5%). Inclusion criteria: Those not meeting current misuse (alcohol > 4 drinks per day or illicit use last 90 days) were excluded. |
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Interventions |
1. Psychosocial intervention: peer‐supported 12‐step self‐help program called Double Trouble in Recovery (DTR), comprising one group meeting per week with a peer facilitator to help develop new skills and coping behaviours, N = 113. 2. Standard care: TAU, received standard residential or day patient treatment and asked not to attend DTR meetings until after follow‐up interview, N = 163. |
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Outcomes | Leaving the study early: lost to treatment, lost to evaluation. Substance use: number of day any alcohol or drug use past 30 days. Mental State: (QoL unable to use; not standard instrument). Medication Adherence (MARS). |
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Notes | Trial identifier: NCT01333280 139 excluded after randomisation as they did not meet recent substance misuse criteria. Primary psychiatric diagnoses not reported. Attendees received $30 for baseline interview, $5 per meeting attended and $50‐100 for follow‐up interviews. Funded by NIDA. One author is director of NGO that receives sales from distribution of DTR material. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table using block randomisation. However, within the 2 regions participants in the two groups differed at baseline on PTSD and bipolar diagnoses. [this issue is addressed in the new ROB2.0 as if randomisation was done appropriately but did not create 2 identical groups then it may indicate that the sequence was not successful (or could be a chance finding)] |
Allocation concealment (selection bias) | Low risk | Allocation concealment was by sealed envelopes (assumed to be consecutively numbered and opaque) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and providers were aware of their group allocation. It is not possible to blind a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome of substance use was by self‐report but was validated by saliva testing |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was 20% in the DTR group and 22% in the control condition with no significant difference between groups. We judged this to be low risk |
Selective reporting (reporting bias) | Low risk | NCT01333280. No indication of selective reporting. |
Other bias | Low risk | NIDA funding |