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. 2019 Nov 1;2019(11):CD012236. doi: 10.1002/14651858.CD012236.pub2

EIPS‐Germany.

Methods Allocation: randomised
Blinding: not stated*
Setting: Cologne, Bonn, Dusseldorf, Munich, Germany
Inclusion criteria: ERIraos criteria, 18‐36 years
Exclusion criteria: < 18 years and > 36 years, treatment with antipsychotics, history of psychotic episode, refusing enrolment in research studies, refusing psychopharmacological treatment, living out of area, moving out of area, delirium, dementia, amnesic or other cognitive disorder, mental retardation, psychiatric disorders due to somatic factor or related to psychotropic substances, alcohol or drug misuse in last 3 months, diseases of central nervous system (inflammatory, traumatic, epilepsy etc.)**
Duration: 36 months (12 months' treatment + 24 months' follow‐up)
Participants Diagnosis: risk for developing psychosis
N = 128
Sex: men and women, ˜60:40% M:F
Age: 18‐36 years, average ˜26, SD 6 years
History: not reported
Interventions 1. IPI: individual CBT, group skills training, cognitive remediation and multifamily psychoeducation, up to 30 sessions. N = 63***
2. Supportive counselling: support, psychoeducation and counselling, up to 30 sessions. N = 65***
Outcomes Transition to psychosis: ERIraos, PANSS
Leaving the study
Functioning: GAF, SAS–II****
Mental state: PANSS (total, positive and negative score), MADRS
Notes *Raters could have been aware of the treatment allocation.
**Presence of inclusion criteria for the LIPS‐Germany was additional exit criteria from EIPS‐Germany study
***After randomisation, 2 in IPI group and 1 in supportive counselling group failed to attend any treatment sessions.
****15 participants not accounted for
*****37 participants not accounted for
Funding: German Federal Ministry of Education and Research
Power analysis, sample size calculation: not reported
Adherence: see Table 14
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by computer‐generated, by block, results placed in sealed envelopes and only opened at the time of treatment allocation
Allocation concealment (selection bias) Unclear risk Quote: "Using sealed envelopes."
Comment: allocation concealment method insufficiently described; it is unclear whether envelopes were sequentially numbered and opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not reported in any of the manuscripts where this study was described. In the study protocol (NCT00204087) it was indicated: "Masking: None (open label)"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "as well as in most trials involving psychosocial interventions it was extremely difficult to make assessments that are totally blind to the treatment condition. Although ratings were mainly carried out by people, who were not involved in treatment, raters could have been aware of the treatment allocation, which raises the possibility that rating bias could have influenced the results."
Comment: high possibility that raters may not have been blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Out of 128 randomised participants, 47 dropped out of the trial before its completion (attrition 37%). In the IPI group, attrition rate was 37% (N = 23, 1 withdrawn from intervention because of suspicion of organic brain disease and 22 lost to follow‐up: 3 moved, 19 did not return). In the supportive counselling group, attrition rate was 37% (N = 24, 24 lost to follow‐up: 7 moved, 17 did not return).
Selective reporting (reporting bias) Low risk All outcomes mentioned in registered protocol (NCT00204087) and publications' methods reported in the manuscript
Other bias Low risk We did not identify any other sources of bias.