Farhall 2009.
Methods | Allocation: randomised Blinding: assessor blind Location: outpatients, in Melbourne, Australia Length of follow‐up: 18 months |
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Participants | Diagnosis: schizophrenia (n = 51); schizoaffective disorder (n = 7); schizophreniform disorder (n = 8); delusional disorder (n = 6); mood disorder with hallucinations/delusions (n = 13); others with positive symptoms (n = 7). (DSM‐IV) N = 94 (92 participants completed the trial) Sex: 55 M, 37 F Age: mean ˜ 32 years, SD ˜ 9.6 years Included: length of illness: not reported; in the opinion of their case manager, one or more recovery needs that could potentially be addressed by a component of the local version of CBTp (see CBT group below) Excluded: participants with a diagnosis of any DSM‐IV non‐psychotic disorder, brief psychotic disorder, drug‐induced psychosis, mood disorder without hallucinations or delusions, or participants with a comorbid intellectual disability or without conversational English |
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Interventions | 1. CBT group*: N = 45 Content: The CBT intervention is based on efficacy trials conducted in the UK (Kuipers 1998). It is similar in scope and content to the therapy outlined by Fowler 1995. Therapists work with participants for 12 ‐ 24 sessions on agreed recovery goals using one or more of the following recovery therapy components: everyday coping, working with symptoms, understanding the experience of psychosis, strengthening adaptive view of self, personal/emotional issues or comorbid disorders, relapse prevention, and family or social reintegration. Delivered by: 12 clinical psychologists Frequency: 12 ‐ 24 sessions Treatment duration: 9 ‐ 12 months after baseline 2. Standard care group: N = 49 Content: Standard care was delivered within a case management framework and comprised medication and one or more of a range of services as required including: information, support, illness education, linkage to other services, assistance with benefits, crisis intervention, and family support. Delivered by: not reported Frequency: not reported Treatment duration: 9 ‐ 12 months after baseline |
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Outcomes | Mental state: general, positive symptoms, negative symptoms, affective symptoms (PANSS scores); anxiety, depression (HADS scores), self‐esteem (RSES scores), insight (SRIS scores) Adverse events: death Functioning: life skills (LSP scores) Satisfaction with treatment: leaving the study early Unable to use: Functioning: general (GAF, WRAT, MMSE scores) ‐ data not reported Satisfaction with treatment: CSQ‐8 (scores) ‐ data not reported |
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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) | Low risk | Quote: "Treatment allocation was randomly assigned on the basis of a tossed coin. The allocation was witnessed by an independent observer. " (p.50) Comments: The author described a random component in the sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comments: The author did not state the allocation concealment method. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The author did not state the method of blinding here. 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: "A research psychologist who was not involved in the therapy intervention administered all assessments but was not blind to participants' group assignments, apart from at baseline. A research assistant who was blind to group assignment scored and analysed the instruments." (p.50) Comments: The outcome assessor was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: Intention‐to‐treat analyses were conducted. |
Selective reporting (reporting bias) | High risk | Comments: Several measured outcomes were not reported. |
Other bias | Low risk | Comments: none obvious |