Methods | Allocation: randomised by block and placed into sealed envelopes, and drawn by individual with no connection to the study. Blinding: single blind. Setting: outpatients, London, UK. Follow-up: 9 months. Inclusion criteria: people with a 1st episode psychosis within the last 6 months. Exclusion criteria: organic disorders, or learning difficulties. Evaluation: assessment made by research assistants blind to allocation |
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Participants | Diagnosis: first-episode psychosis (ICD-9). N=106 patients and their carers*. Age:16 + years. Sex: 68 M, 38 F. History: 1st episode psychosis, recruited from psychiatric services in North London |
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Interventions | 1. Brief intervention and treatment as usual. N=57. 2. Treatment as usual with usual support from psychiatric services. N=49. Brief intervention was provided over seven sessions, lasting about one hour and included information gathering from the relative, an educational component on psychotic illness, symptoms and early warning signs, treatment, and help seeking; coping strategies, problem solving and communication with the patient |
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Outcomes | Leaving the study early. Hospital admission. Unable to use - Satisfaction: Verona Service Satisfaction Questionnaire (no usable data). Perceived severity of illness. |
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Notes | *Carers/relatives were blind to treatment allocation. ITT analysis used. |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomised, no further details. |
Allocation concealment? | Low risk | Using sealed envelopes, drawn by individuals with no connection to the study |
Blinding? All outcomes |
Low risk | Single, untested. |
Incomplete outcome data addressed? All outcomes |
Low risk | Study attrition reported. |
Free of selective reporting? | Unclear risk | No details. |
Free of other bias? | Low risk | Funded by NHS Executive, London Research and Development Programme |