Garety 2008.
Methods | Allocation: randomised
Blinding: assessor blind
Location: five local mental health services in London Length of follow‐up: 24 months |
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Participants | Diagnosis: non‐affective psychosis* (ICD‐10 and DSM‐IV) with at least one positive symptom of moderate severity on the PANSS
Total: N = 301** Sex: 211 M, 90 F Age: mean ˜ 37.1 years, SD ˜ 10.9 years Included: length of illness: mean ˜ 9.9 years, SD ˜ 8.7 years; second or subsequent episode which started not more than three months before entry; rated at least four (moderate severity) on the Positive and Negative Syndrome Scale (PANSS) on at least one positive psychotic symptom Excluded: primary diagnosis of alcoholism or drug misuse, evidence of organic brain disease, and history of organic brain disease and history of violence |
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Interventions |
Pathway 1 (for participants without carers) 1. CBT group*: N = 106 Content: targeted at relapse prevention, done by exploring people's understanding of triggers and risks of relapse and by developing new model of disorder emphasising alternatives to delusional thinking, targets often including persistent negative beliefs about self and others, characteristic reasoning styles such as jumping to conclusions and distressing emotional reactions to events and anomalous experiences; administered by skilled practitioners (doctorial level clinical psychologists) and treatment fidelity assessed using the Cognitive Therapy for Psychosis Adherence Scale Delivered by: five clinical nurse specialists with extensive professional experience of severe mental disorder Frequency: 12 to 20 sessions within 9 months Treatment duration: 9 months 2. Standard care group: N = 112 Content: good standard care delivered according to national and local service protocols and guidelines, including the prescription of antipsychotic medication Delivered by: not reported Frequency: nor reported Treatment duration: 9 months Pathway 2 (for participants with carers) 1. CBT group*: N = 27 Content: targeted at relapse prevention, done by exploring people's understanding of triggers and risks of relapse and by developing new model of disorder emphasising alternatives to delusional thinking, targets often including persistent negative beliefs about self and others, characteristic reasoning styles such as jumping to conclusions and distressing emotional reactions to events and anomalous experiences; administered by skilled practitioners (doctorial level clinical psychologists) and treatment fidelity assessed using the Cognitive Therapy for Psychosis Adherence Scale Delivered by: five clinical nurse specialists with extensive professional experience of severe mental disorder Frequency: 12 to 20 sessions within 9 months Treatment duration: 9 months 2. Family intervention ** group: N = 28 Content: emphasis on improving communication, offering discussion of up‐to‐date information about psychosis, problem‐solving, reducing criticism and conflict, improving activity, and emotional processing of grief, loss and anger Delivered by: 16 mental health professionals Frequency: not stated Treatment duration: 9 months 3. Standard care** group: N = 28 Content: good standard care delivered according to national and local service protocols and guidelines, including the prescription of antipsychotic medication Delivered by: not reported Frequency: not reported Treatment duration: 9 months |
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Outcomes | Global state: relapse Mental state: clinically important change (no improvement); general, positive symptoms, negative symptoms, affective symptoms (PANSS scores), anxiety (BAI scores) Adverse events: suicide attempts, death Functioning: social (SOFAS scores) Quality of life: general (EuroQOL scores) Satisfaction with treatment: leaving the study early Unable to use: Mental state: depression (BDI scores) ‐ skewed data Mental state: delusion, hallucination (PSYRATS) ‐ data not reported Violent incidents ‐ not predefined outcome for this review |
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Notes | *In this trial 'treatment‐as‐usual' was the term used to describe standard care. Participants in CBT and family therapy groups also received the standard care intervention. **We did not use data from the family therapy group and only used data from participants receiving CBT plus standard care or standard care alone (N = 273). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...using randomised permuted blocks with a block size randomly varying between two and ten for the no carer pathway and three and nine for the carer pathway..." (p.413). Comments: adequate randomisation |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation schedules were independently generated by a trial randomisation service in a separate location from all trial centres..." (p.413). Comments: adequate allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Trial research assessors were independent of treatment delivery and every effort was made to ensure they were kept masked to allocation." (p.415) Comments: Participants and therapists knew the group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Trial research assessors were independent of treatment delivery and every effort was made to ensure they were kept masked to allocation." (p.415) Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: Intention‐to‐treat analysis was undertaken. |
Selective reporting (reporting bias) | High risk | Comments: Delusion, hallucination were not reported. |
Other bias | Low risk | Comments: no clear indication of other bias |