Sun 2014.
Methods | Allocation: randomised Blinding: not addressed Location: inpatient, China Length of follow‐up: 12 weeks |
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Participants | Diagnosis: first‐episode schizophrenia (CCMD‐3) N = 100 Sex: 49 M, 51 F Age: 20 ‐ 42 years; mean ˜ 28.8 years, SD ˜ 6.1 years Included: length of illness: 1 ‐ 6 months; mean ˜ 2.3 months, SD ˜ 1.8 months; no experience of medication treatment, able to give informed consent to proposed treatment Excluded: serious physical illness or epilepsy, substance dependence, allergy to drug, pregnancy or lactation |
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Interventions | 1. CBT group*: N = 50 Content: CBT included the building of a therapeutic alliance with participants, functional analysis of symptoms, help to deal with hallucinations and delusions, relaxation training, personal effectiveness training and problem‐solving, as appropriate. Ziprasidone dose range 80 ‐ 160 mg/day, benzodiazepines and benzhexol can be used when necessary. Delivered by: not reported Frequency: a 40‐minute CBT was conducted weekly Treatment duration: 12 weeks 2. Standard care group: N = 50 Content: ziprasidone dose range 80 ‐ 160 mg/day, benzodiazepines and benzhexol can be used when necessary Delivered by: not reported Frequency: not reported Treatment duration: 12 weeks |
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Outcomes | Mental state: general (PANSS scores) Functioning: intelligence (WAIS‐R scores), memory (WMS scores) Unable to use: Functioning: executive functioning (WAIS‐R) ‐ item score rather than subscale score |
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Notes | *Participants in the CBT group also received the standard care intervention. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomly assigned..." (p.54). Comments: No details of the randomisation procedure were provided. Insufficient information to permit judgement of 'Low risk' or 'High risk' |
Allocation concealment (selection bias) | Unclear risk | Comments: The author did not describe allocation concealment. Insufficient information to permit judgement of 'Low risk' or 'High risk' |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The author did not describe the blinding of participants and personnel. However, as the CBT was based on standard care, participants and personnel were not likely to be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: The author did not describe the blinding of outcome assessment. Insufficient information to permit judgement of 'Low risk' or 'High risk' |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: no attrition |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |