Freeman 2014.
Methods | Allocation: randomised Blinding: assessor blind Location: Oxford Health NHS Foundation Trust, UK Length of follow‐up: 12 weeks |
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Participants | Diagnosis: schizophrenia (n = 22); schizoaffective disorder (n = 6); other (n = 2) N = 30 Sex: 20 M, 10 F Age: mean ˜ 41.9 years, SD ˜ 11.5 years Included: length of illness: not reported; a current persecutory delusion; scoring at least 3 on the conviction scale of the PSYRATS; the delusion had persisted for at least three months; negative beliefs about the self as indicated by endorsing at least one negative schematic belief on the Brief Core Schema Scale (BCSS); aged between 18 and 70; and where major changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage Excluded: a primary diagnosis of alcohol or substance dependency; organic syndrome or learning disability; a command of spoken English inadequate for engaging in therapy or the assessments; and currently having individual CBT (though previous experience of CBT was not an exclusion criterion) |
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Interventions | 1. CBT group*: N = 15 Content: 1) negative thoughts about the self, 2) positive activities, and 3) positive thoughts about the self Delivered by: clinical psychologists Frequency: six sessions to each individual over eight weeks Treatment duration: 8 weeks 2. Standard care group: N = 15 Content: Standard care was delivered according to national and local service protocols and guidelines. It usually consisted of prescription of anti‐psychotic medication, visits from a community mental health worker, and regular outpatient appointments with a psychiatrist. Delivered by: not reported Frequency: not reported Treatment duration: 8 weeks |
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Outcomes | Global state: rehospitalisation Mental state: delusions (PsyRATS scores), anxiety (BAI scores), depression (BDI scores), self‐esteem (RSCQ, SCS, BCSS scores), paranoia (GPTS scores), well‐being (WEMWS scores) |
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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: "...randomisation was carried out by using varying randomised permuted blocks via a sequence obtained from web site." (p.2) Comments: Randomisation was well conducted. |
Allocation concealment (selection bias) | Low risk | Quote: "The randomisation was conducted by a researcher independent of recruitment and assessment process." (p.2) Comments: Allocation was well concealed. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Informing patients of allocation was carried out by a therapist." (p.2) Comments: Participants and personnel knew the group assignment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Assessments were carried out by a rater, a graduate psychologist, blind to allocation." (p.2) Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: no attrition |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |