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. 2018 Dec 20;2018(12):CD007964. doi: 10.1002/14651858.CD007964.pub2

Jackson 2009.

Methods Allocation: randomised
Blinding: assessor blind
 Location: four Mental Health Services throughout the West Midlands in the UK
Length of follow‐up: 12 months
Participants Diagnosis: first episode of non‐affective* psychosis (ICD‐10)
N = 76
Sex: 49 M, 17 F
Age: 16 ‐ 35 years, mean ˜ 24.1 years, SD ˜4.7 years
Included: length of illness: mean ˜ 17.4 weeks, SD ˜ 25.4 weeks; experienced a first episode of psychosis within the previous 6 ‐ 18 months
Excluded: non English speakers; unable to give informed consent
Interventions 1. CBT group**: N = 36
Content: The cognitive therapy‐based recovery intervention (CRI) was designed to be delivered on a weekly basis over a 6 month period (i.e. it was limited to a maximum of 26 sessions) and followed a protocol‐based modular approach. There were three key components: (a) engagement and formulation; (b) trauma processing; and (c) appraisals of psychotic illness (shame, loss, and entrapment). The intervention, therefore, is not just designed for those who could be described as 'traumatised' by their experiences of psychosis. It is intended to be helpful for all first episode patients adjusting to and recovering from a first episode of psychosis.
Delivered by: four clinical psychologists and a cognitive behavioural psychotherapist
Freqency: a weekly basis over a 6‐month period
Treatment duration: 6 months
2. Standard care group: N = 30
Content: Those assigned to the standard care group received treatment‐as‐usual from their local mental health services. Standard care consisted of a combination of case management and antipsychotic medication.
Delivered by: not reported
Frequency: not reported
Treatment duration: 6 months
Outcomes Mental state: depression (CDS scores), self‐esteem (RSCQ scores)
Satisfaction with treatment: leaving the study early
Unable to use:
Post‐traumatic phenomena: IES score ‐ not predefined outcome for this review
Attraction, worth, auto self‐regulation, comp, value of existence: RSCQ scores ‐ not predefined outcomes for this review
Notes *We think 'non‐affective' could be schizophrenia, but not necessarily 100%. In this case, we have given this trial the benefit of the doubt and decided to include it.
**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: "Participants were randomly assigned to CBT or Standard care by means of a computerised random number generator administered by the Birmingham University Clinical Trials Unit independent of the research team." (p.455)
Comments: Randomisation was well conducted.
Allocation concealment (selection bias) Low risk Quote: "...random number generator administered by the Birmingham University Clinical Trials Unit independent of the research team." (p.455)
Comments: Participants and investigators enrolling participants could not foresee assignment
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: "In addition, to maintain blindness, therapists and clients were asked not to discuss with the research associates which group they were allocated to and research staff did not attend treatment meetings or access case notes following randomisation. Assessors were asked to record any loss of masking to treatment allocation. " (p.455)
Comments: The outcome assessor was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comments: intention‐to‐treat analysis undertaken
Selective reporting (reporting bias) Low risk Comments: All measured outcomes were reported.
Other bias Low risk Comments: none obvious