Chen 2015.
Methods | Allocation: randomised Blinding: not reported Location: inpatients, China Length of follow‐up: 6 months |
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Participants | Diagnosis: schizophrenia with auditory hallucination N = 50 Sex: 30 M, 20 F Age: mean ˜ 36.7 years, SD ˜ 8.5 years Included: length of illness: mean ˜ 5.32 years, SD ˜ 4.63 years; hallucinations not relieved after receiving medication for at least 2 months; the total score of PANSS ≥ 3; be able to understand and cooperate with the clinicians; give informed consent to proposed treatment Excluded: not reported |
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Interventions | 1. CBT group*, N = 25 Content: The content of CBT was not stated. The dosage of risperidone in the CBT group was 1/3 amount of which was used in antipsychotics control group; benzodiazepines and antan could be used when necessary. Delivered by: not reported Frequency: A 40‐minute CBT was conducted weekly in the first month, twice per month in the third and fourth months and once per month in the fifth and sixth months. Treatment duration: 6 months 2. Standard care group: N = 25 Content: Risperidone was titrated from 1 mg/day to 4 ‐ 6 mg/day, the dose of risperidone was adjusted by the participants' response. Delivered by: not reported Frequency: not reported Treatment duration: 6 months |
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Outcomes | Global state: CGI score (severity scale) Mental state: general , positive symptoms score, negative symptoms score, affective symptoms (PANSS scores); hallucinations (AHRS score) Adverse events: general (TESS score) Quality of life: various specific aspects (SQLS scores) |
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Notes | *Participants in 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: "Participants were randomly assigned..." (p.2063). 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. The study funded by scientific project funding from Department of Science and Technology of Shandong province (112). |