Kuipers 1997.

Methods	Allocation: randomised Blinding: no blinding Location: the Maudsley Trust, London; Addenbrooke's Hospital Trust, Cambridge and Norfolk Mental Health Trust, Norwich, UK Length of follow‐up: 18 months
Participants	Diagnosis: schizophrenia (n = 39); delusion disorder (n = 13); schizoaffective disorder (n = 2) N = 60 Sex: 38 M, 22 F Age:19 ‐ 65 years old Included: length of illness: 1 ‐ 26 years; at least one current positive psychotic symptom (such as delusions or hallucinations) that was distressing, unremitting (at least the past six months) and medication‐resistant, that is, had not responded to a previous trial of at least six months of appropriate antipsychotic medication. Clients prescribed clozapine needed to have been stable on this for at least one year (to allow time for all benefit to occur). Excluded: drug, alcohol or organic problems as primary features
Interventions	1. CBT group*: N = 28 Content: Initial sessions were focused on facilitating engagement in treatment. Considerable effort was spent on building and maintaining a good basic therapeutic relationship, and this relationship was characterised by considerable flexibility on the part of the therapist. When necessary, treatment was arranged in locations convenient to the client, including home visits and proactive outreach. Behavioural therapy techniques, including activity scheduling, relaxation, and skills training. Delivered by: experienced clinical psychologists Frequency: one‐hour session conducted weekly then fortnightly Treatment duration: 9 months 2. Standard care group: N = 32 Content: case management and medication Delivered by: not reported Frequency: not reported Treatment duration: 9 months
Outcomes	Mental state: clinically important change (no improvement) *, general (BPRS scores) Adverse events: death Satisfaction with treatment: leaving the study early Unable to use: Mental state: changes in key psychotic symptoms (PSE‐10, MADS, BAI, BDI, BHS, SCQ scores ‐ data not reported Functioning: social (SFS scores) ‐ data not reported
Notes	*Participants in the CBT group also received the standard care intervention. **A change of less than five points on the BPRS was taken as indicating no reliable clinical change.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "...randomised permuted blocking and a block size of six." (p.319) Comments: adequate randomisation
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	High risk	Quote: "...it is extremely difficult to make assessments that are totally blind to the treatment condition and this was not attempted." (p.319) Comments: blinding of outcome assessment not ensured
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comments: Four participants from the CBT group and seven participants from the control group left the study early. However, no reasons were reported.
Selective reporting (reporting bias)	High risk	Comments: Many measured outcomes were not reported.
Other bias	Low risk	Comments: none obvious