Li 2014.
Methods | Allocation: randomised Blinding: assessor blind Location: inpatients, China Length of follow‐up: 12 months |
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Participants | Diagnosis: schizophrenia (CCMD‐3) N = 80 Sex: 50 M, 30 F Age: mean ˜ 36.7 years, SD ˜ 8.5 years Included: length of illness: mean ˜ 5.32 years, SD ˜ 4.63 years; the item score of hallucination in PANSS ≥ 3; age 20 ‐ 50 years; without receiving antipsychotics, antidepressive drugs, antimanic drugs, and anti‐epileptic drugs four weeks before randomisation Excluded: participants combined with brain organic disease and severe physical disorder; participants who has a history of electric shock; alcohol or drug abuse; other mental disorder; have received CBT before randomisation |
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Interventions | 1. CBT group*: N = 40 Content: psychoeducation about voice; discuss the content of hallucinations; introduction of the ABC model; discuss the link between voice and behaviour; coping strategies Delivered by: not reported Frequency: forty minutes per time; 12 sessions among 6 months Treatment duration: 6 months 2. Standard care group: N = 40 Content: Participants received risperidone titrated upwards from 1 mg/d to 6 mg/d. Benzodiazepine or artane can be used when necessary. Delivered by: not reported Frequency: not reported Treatment duration: 6 months |
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Outcomes | Mental state: general (PANSS scores), hallucinations (AHRS scores) Adverse events: any adverse event, various specific events 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: "Participants were randomly assigned based on random number table." (p.503) Comments: adequate randomisation |
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 | Low risk | Comments: blinded outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: Two participants in the treatment group left the study early. |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |