He 2012.
Methods | Allocation: randomised Blinding: no blinding Location: inpatients, China Length of follow‐up: 12 weeks |
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Participants | Diagnosis: first‐episode paranoia schizophrenia (ICD‐10) N = 100 Sex: 100 M, 0 F Age: mean ˜ 37.8 years, SD ˜ 6.5 years Included: length of illness: mean ˜ 9.82 months, SD ˜ 3.78 months; achieved clinical response (the decreased rate of PANSS total score ≥ 50% or PANSS total score ≤ 60) after acute management; the score of item 'G12' in PANSS scale ≤ 3; 16 ‐ 40 years old; female; participants signed the informed consent; stable condition with current antipsychotics use and no plan to change the medication in future Excluded: participants combined with mental retardation or brain organic disease; participants with severe recession or agitation who are unavailable to cooperate; participants with severe depression, anxiety or drug abuse; participants with severe physical disorder or severe medication; relevant adverse events; lack of insight; the length of hospitalisation more than 1 year |
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Interventions | 1. CBT group*: N = 50 Content: The intervention was based on a cognitive behavioural therapy handbook developed by the investigators. The therapeutic milieu and content was applied according to the handbook. Delivered by: not stated Frequency: a one‐hour CBT intervention every day for 28 days Treatment duration: 28 days 2. Standard care group: N = 50 Content: 15 participants received risperidone, 11 received perphenazine, and 14 participants received quetiapine. Delivered by: not reported Frequency: not reported Treatment duration: 28 days |
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Outcomes | Mental state: anxiety (HAMA scores) Satisfaction with treatment: leaving the study early |
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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) | Low risk | Quote: "Randomly assigned based on random number table." (p.652) Comments: The investigators described a random component in the sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comments: The method of concealment was not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The author did not address this information. However, participants and personnel were not likely to be blinded because participants in the treatment group received CBT, and the control group only received standard care. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: The study did not address blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: high rate of dropouts. Fifteen of fifty in the CBT group and 10 of 50 in the antipsychotics group left the study early. The author did not state reasons for the dropouts. |
Selective reporting (reporting bias) | Low risk | Comments: Ameasured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |