Naeem 2016.
Methods | Allocation: randomised Blinding: assessor blind Location: community mental health services, Canada Length of follow‐up: 16 weeks |
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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 |
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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 |
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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 |
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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 |