Naeem 2005.
Methods | Allocation: randomised. Design: multi‐centre (6 sites, Belfast, Glasgow, Hackney, Newcastle, Southhampton and Swansea). Duration: 3 months. Setting: inpatients and community. Location: Southhampton and Newcastle‐upon‐Tyne, UK. | |
Participants | Diagnosis: 100% ICD‐10 schizophrenia with co‐occurring mild to moderate substance abuse according to HoNOS Item 3* (alcohol 74%, drug use problem 26%**). N = 105. Age: 18 ‐ 65 years. Sex: 87 M, 18 F. Ethnicity: 90% Caucasian. Inclusion criteria: patients with schizophrenia, age 18‐65 years; receiving treatment within mental health services. | |
Interventions | 1. Psychosocial intervention: CBT plus psycho‐education: 6 sessions over 3 months and carers offered 3 sessions along with carer‐oriented information. N = 67.*** 2. Standard care: Routine care. N = 38. | |
Outcomes | Leaving the study early: lost to treatment.
Mental state: Insight Scale. Unable to use Substance use: HoNOS item 3 (data skewed). Mental state: BSA, SCR, CPRS, MADRS (all data skewed). Other: HoNOS ‐ general functioning (data skewed). |
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Notes | ITT analysis. *Patients were excluded if they met a diagnosis of drug or substance misuse dependence. **Based on those participants who provided details (n = 70/105). ***There was a 2:1 ratio to include more participants into the CBT arm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised; random numbers computer‐generated/sealed envelopes stratified by site. Ratio of 2:1 for CBT:TAU. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes opened at the time of treatment allocation. Unclear if envelopes were sequentially numbered and opaque. |
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 blind to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Lost to follow‐up: 14% (15/105) at 3 months. No reasons are given for withdrawals; 10 participants dropped out of treatment versus 5 participants from TAU. Missing values were imputed for full ITT analysis but can have unclear bias effects. |
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. |