Madigan 2013.
Methods | Allocation: randomised.
Design: single‐centre (3 sites).
Duration: 12 months.
Setting: inpatients and community. Location: Dublin, Ireland. |
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Participants | Diagnosis: DSM‐IV diagnosis of psychosis (schizophrenia, n = 38; other psychosis, n = 30) major depression (n = 6) and bipolar disorder (n = 14) and DSM‐IV current cannabis dependence.
N = 88.
Age: mean ˜ 28 years.
Sex: 69 M, 19 F. Ethnicity: Not stated (homogenous group). Inclusion criteria: without learning disability or organic brain damage. |
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Interventions |
1. Psychosocial intervention: CBT + MI group sessions once per week for 12 weeks and invited back 6 weeks later (week 18) for a booster session. Interventions were held in community setting. N = 59.* 2. Standard care: TAU included care from multi‐disciplinary team, 5 patients had counselling for opiate more than one year prior to the present trial. N = 29. |
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Outcomes | Leaving the study early: lost to treatment (3 months), lost to evaluation (9 months). Substance use: frequency of cannabis use last 30 days. Global state: GAF global functioning. Quality of life/life satisfaction: subjective quality of life (WHOQOL, BREF). Unable to use Mental State: SANS. SAPS (positive, negative), Calgary Depression Scale for Schizophrenia (skewed data). |
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Notes | * Note: 2:1 randomisation to CBT/MI arm. A token voucher was given to participants to cover costs of attendance of assessments. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated, block randomised, 2:1 (CBT/MI:TAU) ratio. |
Allocation concealment (selection bias) | Unclear risk | Randomisation was conducted by a researcher uninvolved in the provision or assessment of interventions. Concealment not described in sufficient detail to allow a definite judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Clinician‐/participant‐mediated and participants and personnel not blinded. It is not possible to blind a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Raters of clinical outcomes blind to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Lost to follow‐up: 42% (37/88) 1 year. Similar reasons for missing data across groups. Missing values were not imputed for ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of 'yes' or 'no' as no protocol was available. |
Other bias | Low risk | No evidence other bias occurring. |