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

Naeem 2016.

Methods Allocation: randomised
Blinding: assessor blind
Location: community mental health services, Canada
Length of follow‐up: 16 weeks
Participants Diagnosis: schizophrenia (DSM‐IV)
N = 33
Sex: 17 M, 16 F
Age: ≥ 18 years, mean ˜ 40.5 years, SD ˜ 11.7 years
Included: length of illness not reported; finished at least high school; engaged with mental health services; considered stable for at least six months and has a case manager
Excluded: substance dependence, organic brain syndrome or intellectual disability, high levels of disturbed behaviour, high risk of suicide or homicide based on clinical impression
Interventions 1. CBT group*: N = 18
Content: CBT for psychosis (CBTp) based Guided Self‐help (CBTp‐GSH) consisted of a total of 17 handouts and eight worksheets, that could be flexibly given by a health professional over 12 ‐ 16 sessions. The handouts focused on psychoeducation, dealing with hallucinations, paranoia, changing negative thinking, behavioural activation, problem‐solving, improving relationships, and communication skills. Health professionals were trained in formulating and devising a plan to suit the individuals' needs. The intervention was then delivered according to this plan.
Delivered by: frontline mental health professionals
Frequency: A 15 ‐ 30 minutes CBT was conducted in each session.
Treatment duration: 16 weeks
2. Standard care group: N = 15
Content: conventional drug treatment
Delivered by: not reported
Frequency: not reported
Treatment duration: 16 weeks
Outcomes Mental state: positive symptoms, negative symptoms, affective symptoms (PANSS scores); hallucination, delusion (PsyRATs scores)
General functioning: disability (WHODAS scores)
Satisfaction with treatment: leaving the study early
Unable to use:
Satisfaction with treatment ‐ data not reported for standard care group
Notes *The term 'Treatment‐as‐usual (TAU)' was used in this paper. 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: "Randomization was performed using computer‐generated numbers..." "Block randomisation with randomly permuted block size was used to ensure similar numbers of participants were allocated..." (p.70).
Comments: The investigators described a random component in the sequence generation process.
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 Low risk Comments: The staff to conduct outcome assessments was blinded with the randomisation results.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comments: ITT analysis was applied in this study.
Selective reporting (reporting bias) Low risk Comments: All measured outcomes were reported.
Other bias Low risk Comments: none obvious