Startup 2004.

Methods	Allocation: randomised Blinding: assessor blind Location: psychiatric hospitals, UK Length of follow‐up: 24 months
Participants	Diagnosis: schizophrenia, schizophreniform or schizoaffective disorder N = 90 Sex: 68 M, 22 F Age: 18 ‐ 65 years, mean ˜ 30.5 years, SD ˜ 8.7 years Included: resident within the catchment area, currently experiencing an acute psychotic episode, not already receiving psychological treatment, showing no evidence of organic mental disorder Excluded: not reported
Interventions	1. CBT group*: N = 47 Content: This is a highly individualised, needs‐based form of CBT for psychotic disorders and is based on collaborative empiricism and (evolving) cognitive‐behavioural formulations. Delivered by: clinical psychologists who were employed as specialists in serious mental illness and conducted CBT for schizophrenia on a routine basis Frequency: 90‐minute session, up to a maximum of 25 sessions, were provided at weekly intervals where possible. Treatment duration: 6 months 2. Standard care group: N = 43 Content: Treatment‐as‐usual comprised pharmacotherapy, nursing care during hospitalisation, and community care after discharge. Delivered by: not reported Frequency: not reported Treatment duration: 6 months
Outcomes	Mental state: general (BPRS scores), insight (ITAQ scores) Adverse events: death (any cause) Functioning: general (GAF scores), social (SFS scores) Unable to use: Mental state: psychotic and disorganisation (SAPS subscale scores) ‐ not validated scale Satisfaction with treatment: leaving the study early ‐ data not reported for standard care group
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: "...were randomized to groups by inviting the patients themselves to toss a coin and let it fall to the ground in front of the assessor." (p.420) Comment: 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: "...the follow‐up assessments were not conducted blind to group allocation." (p.420) Comments: The outcome assessor could foresee assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comments: ITT analysis was used to deal with the missing data.
Selective reporting (reporting bias)	Low risk	Comments: All measured outcomes were reported.
Other bias	Unclear risk	Quote: "The baseline general function in TAU group is higher than that in standard care group." (p.420)