Guo 2015.
Methods | Allocation: randomised Blinding: researchers were blinded to randomisation results Location: community care, China Length of follow‐up: 64 weeks |
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Participants | Diagnosis: schizophrenia (ICD‐10) N = 64 Sex: 27 M, 37 F Age: mean ˜ 30.1 years, SD ˜ 7.6 years Included: length of illness: mean ˜ 102.5 months, SD ˜ 76.0 months; participants with age 18 ‐ 60 years old, at least one of the PANSS scores ≥ 3, had been stabilised on antipsychotic medication for at least a 4‐week period, give informed consent to a proposed treatment Excluded: being seriously ill and in hospital or need to be hospitalised, with seriously physical disease or with combination of other psychotic disorders, had not been able to communicate effectively, previous experience of electroconvulsive therapy inside of one month period |
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Interventions | 1. CBT group*: N = 32 Content: CBT procedure was edited according to previous study and guideline (Li 2015 and Wright 2010). Delivered by: rehabilitation therapists Frequency: A 50 ‐ 60 minute CBT was conducted with the first 3 sessions at the first two weeks and the next 5 sessions at the next 10 weeks; in total, there were 8 sessions in 12 weeks. Treatment duration: 12 weeks 2. Standard care group*: N = 32 Content: antipsychotics (first generation and second generation) and nursing Delivered by: not reported Frequency: not reported Treatment duration: 12 weeks |
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Outcomes | Global state: relapse**, rehospitalisation Mental state: clinically important change (no improvement) ***; general, positive symptoms, negative symptoms, affective symptoms (PANSS scores), insight (SAI scores) Functioning: social (PSP scores) Satisfaction with treatment: leaving the study early Unable to use: Type and dosage of antipsychotic drugs received, number of staff on work, duration of work ‐ not predefined outcomes for this review |
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Notes | *The term 'Treatment‐as‐usual (TAU)' was used in this paper; participants in CBT group also received standard care. **Defined as PANSS score of any core symptom > 5 or PANSS score of two symptom > 4 ***Defined as the reducing rate of PANSS score < 25% |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: ''...computer generated random number...'' (p.333). Comments: The investigators described a random component in the sequence generation process. |
Allocation concealment (selection bias) | Low risk | Quote: "An independent researcher organized and assigned the random number." (p.333). Comments: Allocation could not be foreseen. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: No details of the blinding of participants and personnel were provided. 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 | Low risk | Quote: "...participants were not allowed to give group information to researchers..." (p.334). Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: ''ITT analysis was used to deal with drop‐outs.'' (p.335) Comments: 2 participants (6.25%) in CBT group and 9 participants (28.1%) in control group left the study early or were lost to follow‐up. The number was not balanced in the two compared groups and no reasons reported, although ITT analysis was used. The dropout rate of the control group was high. |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious. The study was funded by Beijing Medicine Research and Development Fund (009—1050); China and WHO cooperation: WPCHN1003566. |