Graham 2016.
Methods | Allocation: randomised. Design: Single National Health Service (NHS) Trust. Duration: 2‐week intervention with 3‐month follow‐up. Setting: inpatient and community. Location: Birmingham and West Midlands, UK. |
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Participants | Diagnosis: ICD‐10 Schizophrenia (n = 36), Schizoaffective (N = 5), Bipolar disorder (N = 17) psychosis (N = 1) and abusing alcohol or drugs over the past three months based on DSM‐IV criteria for substance related disorder. N = 59. Age: 38 years. Sex: 50 M 9 F. Ethnicity: Caucasian (48%), Asian (17%), Black (25%), mixed (10%) Inclusion criteria: New admissions with DSM or ICD diagnosis of psychosis and DSM substance related disorder over the last 6 months. |
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Interventions |
1. Psychosocial intervention: Brief integrated MI consisting of 4‐6 (15‐30 minute) sessions over 2 weeks. N = 30. 2. Standard care: TAU. N = 29. |
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Outcomes | Leaving the study early: lost to evaluation. Substance use: number of substances used last 30 days (none vs. one or more). engagement Substance Abuse Treatment Scale (SATs). Unable to use Substance use: number of days substances used and severity of substance use, AUDIT, SDS (skewed data) Mental State: HADS (skewed data) |
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Notes | Trial identifier: ISRCTN43548483 Funded by Institute for Health Research Authors have kindly provided further data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reported as 'randomisation'. Authors confirmed randomised via computer (string was derived in Stats Direct Software) |
Allocation concealment (selection bias) | Low risk | Stated as "central" and by email which implies a separation between the allocation sequence and the person who is allocating the patient (The researcher had to apply for a group allocation, automated via email ‐ assumption) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and providers would be aware of what types of intervention they received. It is not possible to blind a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The primary outcome was based on 'observable behaviours' using the Substance Addiction Treatment Scale (SATS) reported by the primary clinician. The trial is reported as 'independent rater blinded' but it would seem likely that the primary clinician would be aware of the allocation as it was likely to be disclosed by the patient. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2% (1/59) at 3 months. Raw SATS data (primary outcome) for each group were provided by the author. |
Selective reporting (reporting bias) | Low risk | Report outcomes compare well to protocol registered on ISRCTN 43548483 |
Other bias | Low risk | Nil noted. Funded by NIHR. |