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. 2018 Dec 20;2018(12):CD007964. doi: 10.1002/14651858.CD007964.pub2

He 2012.

Methods Allocation: randomised
Blinding: no blinding
Location: inpatients, China
Length of follow‐up: 12 weeks
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
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
Outcomes Mental state: anxiety (HAMA scores)
Satisfaction with treatment: leaving the study early
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