Naeem 2015.
Methods | Allocation: randomised Blinding: Assessors were blind to allocation and were based in a separate location. Location: 2 hospitals, Pakistan Length of follow‐up: 4 months |
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Participants | Diagnosis: schizophrenia or a related disorder (ICD‐10, RDC) N = 116 Sex: 70 M, 46 F Age: 18 ‐ 65 years, mean ˜ 31.1 years, SD ˜ 7.4 years Included: length of illness: mean ˜ 5.8 years, SD ˜ 3.7 years; living within travelling distance of the hospital; having at least 5 years of education or living with a carer with at least 5 years of education Excluded: comorbid alcohol or substance dependence; severe learning impairment; problems due to an organic condition; high levels of disturbed behaviour, or high risk of suicide or homicide |
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Interventions | 1. CBT group*: N = 59 Content: A spiritual dimension was included in formulation, understanding and in therapy plan; equivalents of CBT jargons were used in the therapy; culturally appropriate home work assignments were selected and participants were encouraged to attend even if they were unable to complete their homework; folk stories and examples relevant to the religious beliefs of the local population were used to clarify issues. Delivered by: psychology graduates with more than 5 years experience of working in mental health Frequency: 6 to 10 sessions Treatment duration: 4 months 2. Standard care group: N = 57 Content: This normally consists of prescribing antipsychotic medication as considered suitable by the treating psychiatrist and nursing care. Delivered by: not reported Frequency: not reported Treatment duration: 4 months |
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Outcomes | Mental state: positive symptoms, negative symptoms, affective symptoms (PANSS scores); delusion, hallucination (PSYRATs scores), insight (SAI scores) 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: "...randomly assigned, allocation lists were generated by a web‐based automated randomisation system..." (p.145). Comments: The investigators described a random component in the sequence generation process. |
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 | Quote: "Assessors were blind to allocation and were based in a separate location." (p.144) Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comments: Six participants from CBT group and eight participants from control group left the study early. No reason was reported. |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |