The British Journal of Psychiatry (2017)
210, 342349. doi: 10.1192/bjp.bp.116.190058
Predictors and moderators of treatment outcome
in patients receiving multi-element psychosocial
intervention for early psychosis: results from the
GET UP pragmatic cluster randomised controlled
trial
Antonio Lasalvia, Chiara Bonetto, Jacopo Lenzi, Paola Rucci, Laura Iozzino, Massimo Cellini,
Carla Comacchio, Doriana Cristofalo, Armando DAgostino, Giovanni de Girolamo, Katia De Santi,
Daniela Ghigi, Emanuela Leuci, Maurizio Miceli, Anna Meneghelli, Francesca Pileggi, Silvio Scarone,
Paolo Santonastaso, Stefano Torresani, Sarah Tosato, Angela Veronese, Angelo Fioritti, Mirella Ruggeri
and the GET UP Group*
Background
The GET UP multi-element psychosocial intervention proved
to be superior to treatment as usual in improving outcomes
in patients with first-episode psychosis (FEP). However, to
guide treatment decisions, information on which patients
may benefit more from the intervention is warranted.
Aims
To identify patients characteristics associated with (a) a
better treatment response regardless of treatment type (non-
specific predictors), and (b) a better response to the specific
treatment provided (moderators).
Method
Some demographic and clinical variables were selected
a priori as potential predictors/moderators of outcomes at
9 months. Outcomes were analysed in mixed-effects random
regression models. (Trial registration: ClinicalTrials.gov,
NCT01436331.)
Results
Analyses were performed on 444 patients. Education,
Consistent evidence has been accumulated showing that early
interventions facilitate recovery and reduce long-term disability
in patients with psychosis.1,2 Literature has also shown that early
interventions should be provided on an integrated basis (i.e.
multi-element) and be grounded in evidence-based psychosocial
treatments.35 However, there is as yet no consensus on a service
model for the provision of early interventions for patients with
first-episode psychosis (FEP), nor do we know to what extent early
intervention services are generalisable.68 The GET UP (Genetics,
Endophenotypes, Treatment: Understanding early Psychosis)
PIANO (Psychosis: early Intervention and Assessment of Needs
and Outcome) trial9 was set up to fill this gap. It was designed
to assess early multi-element psychosocial interventions in
epidemiologically representative samples of patients treated in
routine generic mental health settings. A previous paper reported
the feasibility and effectiveness of adding a multi-element psycho-
social intervention to the standard treatment of patients with
FEP. At 9-month follow-up it was clear, based on the retention
rates of patients and families in the experimental arm, that early
*The full list of authors included in the GET UP Group appears in the online
supplement to this paper.
342
duration of untreated psychosis, premorbid adjustment and
insight predicted outcomes regardless of treatment. Only age
at first contact with the services proved to be a moderator
of treatment outcome (patients aged 535 years had greater
improvement in psychopathology), thus suggesting that the
intervention is beneficial to a broad array of patients with
FEP.
Conclusions
Except for patients aged over 35 years, no specific
subgroups benefit more from the multi-element psychosocial
intervention, suggesting that this intervention should be
recommended to all those with FEP seeking treatment in
mental health services.
Declaration of interest
None.
Copyright and usage
B The Royal College of Psychiatrists 2017.
multi-element interventions could be delivered effectively in
routine mental health services. Moreover, compared with patients
receiving routine care, those treated with the early multi-element
interventions displayed greater reductions in overall symptom
severity, and greater improvements in global functioning,
emotional well-being and the subjective burden of delusions.10
Overall, the study findings were consistent with those of a large
trial conducted in the Recovery After an Initial Schizophrenia
Episode (RAISE) initiative, which compared a comprehensive,
multidisciplinary, team-based treatment approach for FEP,
designed for implementation in the USA healthcare system, with
routine community care (i.e. patients in the experimental arm
experienced greater improvement in quality of life, psychopathology
and social functioning).11
In the present study we sought to identify, among baseline
demographic and clinical characteristics, predictors and moderators
of treatment outcomes at 9 months. Existing literature provides
some information on predictors of treatment outcome in patients
with FEP.1217 Available data, however, are rarely based on
epidemiological samples compared with controls, and this
increases the risk of underestimating the complexities of treating
FEP in real-world services.18 The present study attempted to deal

with this gap, and, in particular, aimed to understand: (a) which
patients characteristics are associated with a better treatment
response, regardless of treatment type (non-specific predictors);
and (b) which characteristics are associated with a better response
to the specific FEP treatment provided in the GET UP trial
(moderators). Predictors of outcome across treatment groups
provide prognostic information by clarifying which patients will
respond more favourably to treatment in general, whereas
treatment moderators provide prescriptive information about
optimal treatment selection.19 Although there are clinical
benefits in establishing baseline predictors of overall treatment
success,20 identifying treatment moderators (who will do better
in which treatment) may have more important clinical and cost-
effectiveness implications. Despite the value of identifying the
subgroups of patients and the circumstances associated with the
effectiveness of early multi-element psychosocial interventions
for psychosis, there is as yet little information about moderators
of outcome. These findings would be extremely relevant in order
to clarify generalisability issues of the experimental intervention
effectiveness. The present study aims to fill this knowledge gap.
Based on the existing literature, we hypothesised that, regardless
of treatment, symptomatic improvement at 9 months would be
poorer in men,12 and in people with an early age at onset,13 lower
levels of education,16 a longer duration of untreated psychosis
(DUP),11,21,22 poor premorbid functioning,12,15,16 poor insight,14
lower adherence to medication,23 diagnosis of non-affective
psychosis,24 and higher baseline symptom severity.12,15,16 Given the
lack of available information (with the exception of the DUP as
reported by the RAISE study11), no specific a priori hypotheses
could be made about moderators; thus, moderator analyses will be
exploratory and use the same set of variables analysed as predictors.
Method
The GET UP PIANO trial
The GET UP PIANO trial is a large multicentre randomised
controlled trial comparing an add-on multi-element psychosocial
early intervention with routine care for patients with FEP and
their relatives provided within Italian public general mental
health services. Of the 126 community mental health centres
(CMHCs) located in two northern Italian regions (Veneto and
Emilia-Romagna) and the urban areas of Florence, Milan and
Bolzano, 117 (92.9%) participated, covering an area of 9 304 093
inhabitants. The assignment units (clusters) were the CMHCs,
and the units of observation and analysis were patients and their
families. The trial received approval by the ethics committees of
the coordinating centre (Azienda Ospedaliera Universitaria
Integrata di Verona) and each participating unit and was
registered with ClinicalTrials.gov (NCT01436331). Full details of
the protocol of the GET UP study and the main findings of the
GET UP PIANO trial can be found elsewhere.9,10
Participants
During the index period, all CMHCs participating in the GET UP
PIANO trial were asked to refer individuals with potential cases of
psychosis at first contact to the study team. The inclusion criteria
were: (a) age 1854 years; (b) residence within the catchment areas
of the CMHCs; (c) presence of at least one of the following
symptoms: hallucinations, delusions, qualitative speech disorder,
qualitative psychomotor disorder, bizarre, or grossly inappropriate
behaviour; or two of the following symptoms: loss of interest,
initiative and drive; social withdrawal; episodic severe excitement;
purposeless destructiveness; overwhelming fear; or marked self-
neglect; (d) first lifetime contact with CMHCs, prompted by these
symptoms. Exclusion criteria were: (a) prescribed antipsychotic
Predictors and moderators of treatment outcome for an early psychosis intervention
medication in the past 3 months, for an identical or similar mental
disorder; (b) mental disorders because of a general medical
condition; (c) moderate-severe intellectual disability diagnosis
assessed by a clinical functional assessment; and (d) diagnosis
other than ICD-10 for psychosis25 (with the exception of non-
psychotic disorders comorbid with a primary diagnosis of
psychosis). All eligible patients who achieved clinical stabilisation
were invited to provide written informed consent for assessment.
They were told of the nature, scope and possible consequences of
the trial and that they could withdraw consent at any time. They
were also asked to give consent for family member assessments;
family members who agreed to participate provided written
informed consent.
The specific ICD-10 codes for psychosis (F1x.4; F1x.5; F1x.7;
F2029; F30.2, F31.2, F31.5, F31.6, F32.3, F33.3) were assigned
at 9 months; the best-estimate ICD-10 diagnosis was made by
consensus of a panel of clinicians taking into account all available
information on the time interval from patients intake by
completing the Item Group Checklist (IGC) of the Schedule for
Clinical Assessment in Neuropsychiatry (SCAN).26
Treatments
The experimental treatment consisted of a multi-element psycho-
social intervention, adjunctive to routine care. It included the
delivery of cognitivebehavioural therapy (CBT) for psychosis to
patients,27,28 and of psychosis-focused family intervention29 to
families, together with case management30 involving both patients
and their families. It was provided by CMHC staff, trained in the
previous 6 months and supervised by experts. The intervention
began as soon as patients achieved clinical stabilisation (i.e. a
condition in which they could collaborate in a brief clinical
examination). Core baseline measures were taken. Control arm
CMHCs provided only treatment as usual (TAU), which, in Italy,
comprises personalised out-patient psychopharmacological treat-
ment and non-specific supportive clinical management by the
CMHC.31 Family interventions in TAU consisted of non-specific
informal support sessions.
Measures
A set of core outcome instruments (Positive and Negative
Syndrome Scale (PANSS),32 Global Assessment of Functioning
(GAF),33 Hamilton Rating Scale for Depression (HRSD)34) was
administered by a panel of 17 independent evaluators at baseline
(after clinical stabilisation and before treatment was initiated) and
at 9-month follow-up. For the PANSS the three traditional sub-
scales were considered positive symptoms, negative symptoms
and general psychopathology.
An extensive set of standardised instruments was also
administered at baseline, including the Premorbid Social
Adjustment scale (PSA)35 for premorbid functioning, the
Schedule for Assessment of Insight (SAI-E)36 for insight into
illness and a modified version of the Nottingham Onset Schedule
(NOS)37 for the DUP. These clinical measures, together with base-
line sociodemographics (gender, age at first contact, citizenship,
education) were analysed as putative predictors/moderators.
All the 17 independent evaluators were trained in the
administration and rating of the instruments. For the interrater
reliability, each evaluator independently rated three videos on
the PANSS, which were recorded and rated by an independent
clinician. High levels of agreement (mean percentage agreement
on the items of each scale) were reached between each evaluator
and the clinician. Specifically, 85% for the positive scale, 70%
for the negative scale and 82% for the general scale. The intraclass
correlation coefficient was 0.81. Patients, clinicians and evaluators
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could not be masked to the trial arm. Every effort was made to
preserve the evaluators independence; conflicts of interest were
monitored.
Statistical analyses
Analyses were conducted using an intention-to-treat (ITT)
approach. PANSS, GAF and HRSD scores were analysed separately
in mixed-effects random regression models. In order to take into
account the trial design in which patients (level 1) were nested
within CMHCs (level 2) (CONSORT guidelines for cluster
randomised trials38), the individual CMHCs were included in
the models as a random effect. In order to identify predictors
and moderators of treatment outcome according to MacArthurs
approach,20 we selected a priori, on clinical or empirical grounds
and derived from the literature, a subset of demographic and
baseline clinical variables. Specifically, we investigated gender,
age at first contact, citizenship (Italian/non-Italian), educational
level (high/low), DUP, type of psychosis (affective/non-affective),
premorbid functioning (four components: school and social
functioning, in both childhood and adolescence) and insight into
illness (three components: attribution of symptoms, illness
awareness and treatment adherence). Each model included treat-
ment allocation (T coded as + for patients in the experimental
treatment group and 7 for those in the TAU group), one
predictor/moderator (M standardised), their interaction (T6M)
and the baseline score of the outcome investigated (B standardised).
When the main effect of a variable was significant but the interaction
was not, the variable was considered a non-specific predictor of
outcome. When the interaction was significant (regardless of the
significance of main effects), the variable was considered as a
moderator. For each variable, the predictor and moderator effect
size was calculated using the formulae provided by Kraemer.39
In a secondary analysis, missing data on outcomes were
estimated using a multiple imputation approach by chained
equations (MICE), which generates several different plausible
imputed data-sets and combines results from each of them. MICE
was applied because it allows one to handle different variable
types; specifically, we used predictive mean matching to deal with
possible non-normality when imputing continuous variables and
logistic regression to impute binary variables. The alpha level
was set to 0.05 for all main effects and interactions. All statistical
analyses were carried out using the Stata software package,
version 13.
Results
Demographic and clinical variables of the 444 study participants
examined as potential predictors or moderators of treatment
outcome are presented in online Table DS1.
Predictors
Some attributes of patients predicted outcomes regardless of
treatment assignment. Among sociodemographic characteristics
(Table 1), higher education predicted lower overall symptoms
(b = 70.06, P = 0.034), negative symptoms (b = 70.11, P = 0.009)
and general psychopathology (b = 70.06, P = 0.046) at 9 months.
Several clinical characteristics predicted outcomes at 9 months

Table 1 Sociodemographic characteristics as potential predictors/moderators of treatment outcome a

b (95% CI), P r(DO, DM)b
Outcome at follow-up Interaction with treatment, Predictor Moderator
(adjusted for baseline) Main effect, prediction moderation effect size effect size

Age at first contact

PANSS total 0.04 (70.02 to 0.09), 0.157 70.12 (70.23 to 70.01), 0.032* 0.04 70.06
PANSS positive 70.00 (70.06 to 0.05), 0.889 70.07 (70.8 to 0.05), 0.238 0.00 70.03
PANSS negative 0.06 (70.02 to 0.14), 0.155 70.17 (70.34 to 70.01), 0.042* 0.04 70.06
PANSS general 0.06 (0.00 to 0.11), 0.039 70.14 (70.25 to 70.03), 0.014* 0.06 70.07
GAF score 70.44 (71.95 to 1.07), 0.570 70.13 (73.19 to 2.93), 0.934 70.02 0.00
HRSD score 0.34 (70.51 to 1.18), 0.432 70.13 (71.83 to 1.56), 0.878 0.02 0.00
Gender (reference men)
PANSS total 0.00 (70.05 to 0.06), 0.944 0.04 (70.07 to 0.14), 0.511 0.00 0.02
PANSS positive 0.04 (70.02 to 0.10), 0.179 0.04 (70.07 to 0.16), 0.438 0.03 0.02
PANSS negative 70.02 (70.10 to 0.07), 0.711 70.04 (70.21 to 0.12), 0.595 70.01 70.01
PANSS general 70.01 (70.06 to 0.05), 0.725 0.07 (70.04 to 0.18), 0.227 70.01 0.03
GAF score 70.94 (72.42 to 0.54), 0.213 0.30 (72.67 to 3.26), 0.845 70.03 0.01
HRSD score 0.50 (70.32 to 1.33), 0.229 0.46 (71.19 to 2.10), 0.588 0.03 0.01
Citizenship (reference Italian)
PANSS total 0.01 (70.04 to 0.06), 0.646 70.02 (70.13 to 0.08), 0.647 0.01 70.01
PANSS positive 0.02 (70.03 to 0.08), 0.460 70.04 (70.16 to 0.07), 0.429 0.02 70.02
PANSS negative 0.01 (70.07 to 0.09), 0.860 70.01 (70.17 to 0.15), 0.899 0.00 0.00
PANSS general 0.01 (70.04 to 0.06), 0.691 70.05 (70.15 to 0.06), 0.381 0.01 70.02
GAF score 0.19 (71.23 to 1.62), 0.791 0.79 (72.07 to 3.64), 0.589 0.01 0.01
HRSD score 0.26 (70.56 to 1.09), 0.529 0.10 (71.55 to 1.75), 0.906 0.02 0.00
Education (reference high level)
PANSS total 70.06 (70.12 to 70.00), 0.034* 70.00 (70.11 to 0.11), 0.996 70.06 0.00
PANSS positive 70.03 (70.09 to 0.02), 0.253 70.02 (70.13 to 0.10), 0.751 70.03 70.01
PANSS negative 70.11 (70.20 to 70.03), 0.009* 0.02 (70.15 to 0.19), 0.832 70.07 0.01
PANSS general 70.06 (70.11 to 70.00), 0.046 0.00 (70.11 to 0.11), 0.980 70.06 0.00
GAF score 1.47 (70.04 to 2.99), 0.057 0.48 (72.55 to 3.50), 0.758 0.05 0.01
HRSD score 70.65 (71.52 to 0.21), 0.136 0.65 (71.07 to 2.36), 0.461 70.04 0.02

PANSS, Positive and Negative Syndrome Scale; GAF, Global Assessment of Functioning; HRSD, Hamilton Rating Scale for Depression.
a. Mixed-effects random regression models estimated for patients who were assessed at both baseline and follow-up (experimental treatment group, n = 239; treatment-as-usual
group, n = 153).
b. See Kraemer for the calculation of predictor and moderator effect size.39
*Predictors/moderators that remained significant (P50.05) after applying multiple imputation procedure by chained equations (MICE).

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(Table 2 and Table 3): specifically, a longer DUP predicted
higher depressive symptoms (b = 1.42, P = 0.002); poorer
premorbid social functioning in adolescence predicted higher
levels of overall psychotic symptoms (b = 0.07, P = 0.043) and
depressive symptoms (b = 0.90, P = 0.039); and poorer premorbid
scholastic functioning in adolescence predicted higher negative
symptoms (b = 0.11, P = 0.035). Moreover, poorer attribution of
symptoms predicted higher severity of overall psychotic symptoms
(b = 70.07, P = 0.036), higher levels of positive symptoms
(b = 70.12, P = 0.003) and worse global functioning (b = 2.75,
P = 0.008); and poorer treatment adherence predicted higher level
of overall psychotic symptoms (b = 70.08, P = 0.015), positive
symptoms (b = 70.08, P = 0.017), negative symptoms (b = 70.11,
P = 0.031) and general psychopathology (b = 70.06, P = 0.045).
Multiple imputation analysis confirmed that lower education
predicted a higher severity of symptoms at follow-up (PANSS total
score, b = 70.10, P = 0.016) and that a poorer attribution of
symptoms predicted a higher severity of positive symptoms
(PANSS positive score). Notably, lower educational level
(b = 70.10, p = 0.016), poorer school performance in adolescence
(b = 0.11, P = 0.022) and poorer treatment adherence (b = 70.10,
P = 0.042) predicted a higher severity of negative symptoms
(PANSS negative score). A longer DUP predicted a greater severity
of depression (b = 1.11, P = 0.005), and a poorer attribution of
symptoms predicted worse global functioning at follow-up
(b = 2.14, P = 0.020).
Moderators
We found a differential effect of age at first contact on PANSS total
score (b = 70.12, P = 0.032), negative symptoms (b = 70.17,
P = 0.042) and general psychopathology (b = 70.14, P = 0.014)
(Table 2). Specifically, the experimental treatment became more
beneficial than TAU as age increased. When analyses were rerun
using multiple imputation of missing data, the finding that age
at first contact was a moderator of PANSS total score
(b = 70.11, P = 0.052), negative symptoms (b = 0.18, P = 0.032)
and general psychopathology (b = 70.12, P = 0.030) was confirmed.
In order to determine the age cut-off at which the experimental
treatment started to be significantly superior to TAU, age was
categorised using different cut-offs (20, 25, 30, 35 years) in a
sensitivity analysis. This analysis showed that starting from
35 years of age there was a significant treatment effect on PANSS
(PANSS total: b = 70.12, P = 0.023, moderator effect size = 70.06;
PANSS negative: b = 70.18, P = 0.032, moderator effect

Table 2 Duration of untreated psychosis (DUP), insight (Schedule for Assessment of Insight (SAI)) and diagnosis as potential
predictors/moderators of treatment outcome a
b (95% CI), P r(DO, DM)b
Outcome at follow-up Interaction with treatment, Predictor Moderator
(adjusted for baseline) Main effect, prediction moderation effect size effect size

DUP (months)
PANSS total 0.04 (70.02 to 0.09), 0.171 0.00 (70.11 to 0.11), 0.967 0.04 0.00
PANSS positive 0.03 (70.03 to 0.09), 0.266 0.01 (70.11 to 0.13), 0.855 0.03 0.00
PANSS negative 0.08 (70.00 to 0.17), 0.055 0.01 (70.16 to 0.18), 0.927 0.05 0.00
PANSS general 0.03 (70.02 to 0.09), 0.267 0.00 (70.11 to 0.12), 0.978 0.03 0.00
GAF score 70.84 (72.46 to 0.77), 0.308 0.15 (73.04 to 3.34), 0.927 70.03 0.00
HRSD score 1.42 (0.53 to 2.31), 0.002* 70.83 (72.62 to 0.95), 0.361 0.08 70.03
SAI attribution of symptoms
PANSS total 70.07 (70.14 to 70.00), 0.036 70.04 (70.18 to 0.09), 0.538 70.08 70.02
PANSS positive 70.12 (70.20 to 70.04), 0.003* 70.06 (70.21 to 0.09), 0.447 70.11 70.03
PANSS negative 70.09 (70.19 to 0.01), 0.084 70.16 (70.36 to 0.04), 0.120 70.06 70.06
PANSS general 70.06 (70.13 to 0.01), 0.108 70.01 (70.14 to 0.13), 0.919 70.06 0.00
GAF score 2.75 (0.71 to 4.80), 0.008* 72.08 (75.98 to 1.82), 0.297 0.10 70.04
HRSD score 70.87 (71.75 to 0.00), 0.051 0.10 (71.64 to 1.84), 0.910 70.07 0.00
SAI illness awareness
PANSS total 0.02 (70.07 to 0.10), 0.711 0.10 (70.06 to 0.26), 0.231 0.02 0.06
PANSS positive 70.02 (70.10 to 0.07), 0.668 0.02 (70.16 to 0.19), 0.852 70.02 0.01
PANSS negative 0.04 (70.08 to 0.17), 0.471 0.08 (70.17 to 0.32), 0.534 0.04 0.03
PANSS general 0.01 (70.07 to 0.09), 0.865 0.13 (70.04 to 0.29), 0.125 0.01 0.07
GAF score 70.29 (72.72 to 2.14), 0.815 72.17 (77.17 to 2.83), 0.394 70.01 70.04
HRSD score 70.11 (71.27 to 1.05), 0.858 2.32 (0.02 to 4.62), 0.048 70.01 0.09
SAI treatment adherence
PANSS total 70.08 (70.14 to 70.02), 0.015 70.07 (70.20 to 0.05), 0.268 70.08 70.04
PANSS positive 70.08 (70.15 to 70.01), 0.017 70.07 (70.20 to 0.06), 0.312 70.08 70.03
PANSS negative 70.11 (70.21 to 70.01), 0.031* 70.11 (70.31 to 0.08), 0.265 70.07 70.04
PANSS general 70.06 (70.13 to 70.00), 0.045 70.07 (70.19 to 0.06), 0.285 70.07 70.04
GAF score 1.30 (70.56 to 3.16), 0.170 1.75 (71.88 to 5.38), 0.344 0.05 0.03
HRSD score 70.51 (71.32 to 0.29), 0.212 70.72 (72.34 to 0.89), 0.381 70.04 70.03
Type of psychosis (reference affective)
PANSS total 0.02 (70.04 to 0.07), 0.558 70.02 (70.14 to 0.09), 0.659 0.02 70.01
PANSS positive 0.03 (70.03 to 0.08), 0.310 70.02 (70.13 to 0.10), 0.763 0.03 70.01
PANSS negative 0.02 (70.06 to 0.10), 0.645 70.06 (70.23 to 0.11), 0.471 0.01 70.02
PANSS general 0.01 (70.04 to 0.07), 0.631 70.02 (70.13 to 0.10), 0.779 0.01 70.01
GAF score 71.38 (72.92 to 0.15), 0.077 70.15 (73.18 to 2.88), 0.922 70.05 0.00
HRSD score 0.47 (70.35 to 1.30), 0.261 70.88 (72.54 to 0.77), 0.296 0.03 70.03

PANSS, Positive and Negative Syndrome Scale; GAF, Global Assessment of Functioning; HRSD, Hamilton Rating Scale for Depression.
a. Mixed-effects random regression models estimated for patients who were assessed at both baseline and follow-up (experimental treatment group, n = 239; treatment-as-usual
group, n = 153).
b. See Kraemer for the calculation of predictor and moderator effect size.39
*Predictors/moderators that remained significant (P50.05) after applying multiple imputation procedure by chained equations (MICE).

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Table 3 Premorbid social adjustment (PSA) scale as potential predictor/moderator of treatment outcome a
b (95% CI), P r(DO, DM)b
Outcome at follow-up Interaction with treatment, Predictor Moderator
(adjusted for baseline) Main effect, prediction moderation effect size effect size

PSA social childhood

PANSS total 70.01 (70.08 to 0.06), 0.790 0.07 (70.06 to 0.21), 0.279 70.01 0.04
PANSS positive 70.01 (70.08 to 0.05), 0.694 0.07 (70.06 to 0.20), 0.300 70.01 0.04
PANSS negative 70.02 (70.13 to 0.08), 0.656 0.18 (70.02 to 0.39), 0.083 70.02 0.06
PANSS general 0.00 (70.06 to 0.07), 0.892 0.04 (70.10 to 0.17), 0.599 0.00 0.02
GAF score 70.01 (71.96 to 1.93), 0.990 71.75 (75.63 to 2.13), 0.376 0.00 70.03
HRSD score 0.27 (70.59 to 1.13), 0.534 0.68 (71.03 to 2.39), 0.436 0.02 0.03
PSA school childhood
PANSS total 0.05 (70.02 to 0.12), 0.132 70.02 (70.16 to 0.12), 0.759 0.06 70.01
PANSS positive 0.05 (70.02 to 0.11), 0.154 0.01 (70.12 to 0.14), 0.881 0.05 0.01
PANSS negative 0.07 (70.04 to 0.18), 0.196 70.09 (70.30 to 0.12), 0.396 0.05 70.03
PANSS general 0.05 (70.02 to 0.12), 0.149 70.01 (70.15 to 0.13), 0.888 0.05 70.01
GAF score 71.85 (73.83 to 0.14), 0.069 1.35 (72.59 to 5.28), 0.503 70.06 0.02
HRSD score 0.79 (70.08 to 1.66), 0.076 70.12 (71.87 to 1.62), 0.890 0.06 70.01
PSA social adolescence
PANSS total 0.07 (0.00 to 0.14), 0.043 0.01 (70.12 to 0.15), 0.851 0.07 0.01
PANSS positive 0.04 (70.03 to 0.11), 0.246 70.05 (70.18 to 0.08), 0.463 0.04 70.03
PANSS negative 0.10 (70.00 to 0.21), 0.063 0.08 (70.13 to 0.28), 0.473 0.07 0.03
PANSS general 0.06 (70.00 to 0.13), 0.063 0.01 (70.13 to 0.14), 0.915 0.07 0.00
GAF score 71.24 (73.18 to 0.71), 0.212 72.27 (76.09 to 1.56), 0.246 70.04 70.04
HRSD score 0.90 (0.05 to 1.76), 0.039 70.74 (72.44 to 0.96), 0.395 0.07 70.03
PSA school adolescence
PANSS total 0.05 (70.02 to 0.12), 0.169 0.02 (70.11 to 0.16), 0.729 0.05 0.01
PANSS positive 0.04 (70.03 to 0.10), 0.276 0.06 (70.07 to 0.19), 0.349 0.04 0.03
PANSS negative 0.11 (0.01 to 0.22), 0.035* 70.10 (70.31 to 0.11), 0.366 0.07 70.03
PANSS general 0.03 (70.04 to 0.10), 0.407 0.06 (70.07 to 0.20), 0.359 0.03 0.03
GAF score 71.67 (73.63 to 0.29), 0.094 1.49 (72.41 to 5.40), 0.453 70.06 0.03
HRSD score 0.77 (70.08 to 1.63), 0.077 0.74 (70.97 to 2.45), 0.397 0.06 0.03

PANSS, Positive and Negative Syndrome Scale; GAF, Global Assessment of Functioning; HRSD, Hamilton Rating Scale for Depression.
a. Mixed-effects random regression models estimated for patients who were assessed at both baseline and follow-up (experimental treatment group, n = 239; treatment-as-usual
group, n = 153).
b. See Kraemer for the calculation of predictor and moderator effect size.39
*Predictors/moderators that remained significant (P50.05) after applying multiple imputation procedure by chained equations (MICE).

size = 70.06; PANSS general: b = 70.13, P = 0.015, moderator experienced some benefit from both treatments, with a higher
effect size = 70.07) (Fig. 1). beneficial effect of experimental treatment in terms of reduction
Table 4 (lower part) shows that in the TAU arm patients in PANSS total, negative and general scores.
with an age of onset 535 years experienced no reduction of These findings were confirmed after multiple imputation of
overall psychotic symptoms, negative symptoms and general missing data (results not shown). In order to identify possible
psychopathology at 9 months (see delta scores), whereas patients reasons for this finding, we carried out secondary analyses comparing
with an age of onset less than 35 years (Table 4, upper part) patients with an age of onset 535 years with the rest of the sample.
Results indicate that patients with age at onset 535 years were
Table 4 Strength of moderation by patients age at first
more often females (41.0% v. 67.0%, w2 test, P50.001), less frequently
contact (535 years, 535 years) on the effect of intervention diagnosed with schizophrenia (19.4% v. 30.7%, w2 test, P = 0.033),
(experimental v. treatment as usual) on the various outcome less frequently unmarried (37.9% v. 91.3%, w2 test, P50.001) and
domains unemployed or students (46.6% v. 70.4%, w2 test, P50.001).
Delta, mean Finally, we found that a greater awareness of illness was
Outcome Treatment-as-usual group Experimental group
associated with a higher severity of depression at follow-up in
the experimental group but not in the control group (b = 2.32,
535 years P = 0.048) (Table 2); this finding, however, was not confirmed in
GAF 15.2 (14.9) 19.4 (16.6)
multiple imputation analysis (b = 0.38, P = 0.736). No moderation
PANSS positive 70.68 (0.81) 70.77 (0.81)
PANSS negative 70.68 (1.02) 70.67 (1.00)
was found for GAF and HRSD.
PANSS general 70.56 (0.70) 70.66 (0.73)
PANSS total score 70.63 (0.68) 70.69 (0.70) Discussion
HRSD 75.8 (13.3) 78.8 (1.0)
535 years This is the first study to investigate in a real-world setting which
GAF 13.0 (12.8) 18.3 (16.6) patient characteristics: (a) predict outcome regardless of treatment
PANSS positive 70.71 (0.78) 70.95 (0.72) assignment (non-specific predictors), and (b) moderate differential
PANSS negative 70.21 (0.69) 70.58 (0.93) response (moderators) to an adjunctive multi-element psychosocial
PANSS general 70.33 (0.51) 70.65 (0.60) intervention supplementing routine care for FEP. It used a large
PANSS total score 70.41 (0.48) 70.70 (0.56)
sample and a robust methodological approach.
HRSD 76.7 (13.0) 77.0 (10.2)
As expected, we found several non-specific predictors of
GAF, Global Assessment of Functioning; PANSS, Positive and Negative Syndrome outcome. Patients with lower education, longer DUP, poorer
Scale; HRSD, Hamilton Rating Scale for Depression.
premorbid functioning in adolescence and poorer insight into

346
 Predictors and moderators of treatment outcome for an early psychosis intervention

(a)
3 3
2.8 535 years 2.8 535 years
2.6 TAU 2.6 TAU
2.4 2.4
2.2 EXP 2.2 EXP
Total

2 2
1.8 1.8
1.6 1.6
1.4 1.4
1.2 1.2
1 1
Baseline Follow-up Baseline Follow-up

(b)
3 3
535 years 535 years
2.8 2.8
2.6 TAU 2.6 TAU
2.4 EXP 2.4 EXP
Negative

2.2 2.2
2 2
1.8 1.8
1.6 1.6
1.4 1.4
1.2 1.2
1 1
Baseline Follow-up Baseline Follow-up

(c)
3 3
535 years 535 years
2.8 2.8
2.6 TAU 2.6 TAU
2.4 EXP 2.4 EXP
2.2 2.2
General

2 2
1.8 1.8
1.6 1.6
1.4 1.4
1.2 1.2
1 1
Baseline Follow-up Baseline Follow-up

Fig. 1 Strength of moderation by patients age at first contact on the effect of the intervention (experimental EXP) v. treatment-as-usual
(TAU) group) on the Positive and Negative Syndrome Scale (PANSS).
Left-hand graphs 535 years at first contact, right-hand graphs: 535 years at first contact. (a) Total score; (b) negative symptoms; (c) general psychopathology. Mean scores
are reported on the y-axis; 1, absent; 2, minimal; 3, mild; 4, moderate; 5, moderate-severe; 6, severe; 7, extremely severe).

illness showed poorer clinical outcomes at 9 months irrespective
of the type of treatment. These findings are consistent with the
literature1117,2023 and suggest that patients with FEP with these
characteristics warrant specific attention and may require more
intensive and/or longer treatment.
We found only one significant moderator that acted only on one
outcome: patients age at first service contact, which operated on
negative symptoms and general psychopathology. Specifically, in
the control group, where the effect of the intervention was overall
lower than in the experimental group, the moderation effect by age
at first service contact resulted in lower benefit in older compared with
younger patients. Thus, the experimental intervention was not only
overall significantly more effective than TAU, but was also similar in
both age groups, showing greater generalisability.
The multi-element psychosocial intervention administered at
the first psychotic episode seems to exert a specific additional
beneficial effect on patients who develop onset of psychosis at a
later stage (535 years); these patients, if treated with usual care
alone, would display no or low symptomatic improvement.
Moreover, it is important to note that the multi-component
intervention showed a specific beneficial effect on negative
symptoms, which in general show relatively poorer response to
psychopharmacological treatment in patients with FEP.40,41
It is not completely clear what drives the relationship between
age at first contact and experimental treatment outcome in our
sample. However, data showing that patients with age at onset
535 years were more often women, less frequently diagnosed with
schizophrenia, less frequently unmarried and unemployed or a
student may in part explain the moderating effect of age at first
contact on treatment outcome in our sample. We may also
speculate that patients developing psychosis at a later stage may
be more receptive to structured cognitive coping strategies
provided with both individual CBT and family therapy, since these
patients have been found to be less impaired than younger
patients on a broad array of cognitive tasks,4245 which are most
relevant to adaptive functioning and treatment response. This issue
has some interesting implications, since the idea of intervening early
should not be conflated with intervening in the young, as psychosis
has an impact at all stages of life. A new line of research is specifically
focusing on people over 35 years presenting to mental health services
with a first psychotic episode. This research found that a large
proportion (55%) of patients with FEP present after the age of
25 years46 and suggested extending early intervention provision
to all ages, with treatment tailored to the specific needs of different
age groups.47,48 However, future research should further investigate
the relationship between age and outcome in FEP samples.

347
Lasalvia et al
Overall, the lack of significant moderators of treatment out-
comes suggests that the effects of the experimental intervention do
not vary according to patient baseline characteristics and that its
beneficial effect is generalisable to the overall study population.
The fact that (apart from patients 535 years) no specific subgroups
benefit more from the experimental intervention indicates that early
multi-element psychosocial intervention should be recommended to
all patients with FEP treated in routine mental health services.
Study limitations
Our moderator analyses should be considered as exploratory,
being aimed at providing useful information for designing future
clinical studies. The effect size of the moderators identified in the
present paper may serve as guidance to researchers for estimating
the sample size needed in confirmation studies. In order to test
hypotheses on moderating effects, confirmatory studies would
be needed, including an adequately sized group of patients with
the characteristics of interest (for example, age 535 years), in
which the outcomes of patients receiving different treatments
(i.e. TAU v. GET UP intervention) are compared.
Another potential limitation is the lack of masking in the trial
(patients, clinicians, other care providers and outcome evaluators
were aware of treatment allocation). The study design (cluster)
and the nature of the treatments under investigation did not permit
masking. This limitation is inevitable and common to many cluster
randomised trials investigating the effects of psychosocial inter-
ventions provided in routine care.49 However, we tried to reduce
the possible bias of unmasked outcome assessment by employing
evaluators who were independent from the research team and who
were not involved in treatment provision; every effort was also
made throughout the trial to preserve the outcome evaluators
independence; conflicts of interest were also monitored.
Further research
Our findings provide evidence that the GET UP multi-element
psychosocial intervention is beneficial to a broad array of patients
with FEP treated within routine community mental health
services, and especially among those over 35 years of age. Further
studies in other geographical contexts and with longer-term
outcomes are needed to replicate and extend our findings.
Antonio Lasalvia, MD PhD, UOC Psichiatria, Azienda Ospedaliera Universitaria
Integrata (AOUI), Verona; Chiara Bonetto, PhD, Department of Neurosciences,
Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona,
Verona; Jacopo Lenzi, PhD, Paola Rucci, PhD, Department of Biomedical and
Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna; Laura
Iozzino, Department of Neurosciences, Biomedicine and Movement Sciences, Section
of Psychiatry, University of Verona, Verona; Massimo Cellini, Department of Mental
Health, Az. USL Firenze, Firenze; Carla Comacchio, MD, Doriana Cristofalo,
Department of Neurosciences, Biomedicine and Movement Sciences, Section of
Psychiatry, University of Verona, Verona; Armando DAgostino, MD, Department of
Psychiatry, University of Milano, Milano; Giovanni de Girolamo, MD, IRCSS St John
of God Clinical Research Centre of Brescia, Brescia; Katia De Santi, MD, UOC
Psichiatria, Azienda Ospedaliera Universitaria Integrata (AOUI), Verona; Daniela Ghigi,
MD, Department of Mental Health, Az. USL Rimini, Rimini; Emanuela Leuci, MD,
Department of Mental Health, Az. USL Parma; Maurizio Miceli, MD, Department of
Mental Health, Az. USL Firenze, Firenze; Anna Meneghelli, AO Ospedale Niguarda Ca
Granda Milano, MHD Programma2000, Milan; Francesca Pileggi, MD, Department
of Mental Health, Az. USL Bologna, Bologna; Silvio Scarone, MD, Department of
Psychiatry, University of Milano, Milano; Paolo Santonastaso, MD, Department of
Neurosciences, University of Padova and Azienda Ospedaliera, Padova; Stefano
Torresani, MD, Department of Mental Health, Az. USL Bolzano, Bolzano; Sarah Tosato,
MD, PhD, Department of Neurosciences, Biomedicine and Movement Sciences, Section
of Psychiatry, University of Verona, Verona; Angela Veronese, MD, Department of
Neurosciences, University of Padova and Azienda Ospedaliera, Padova; Angelo Fioritti,
MD, Department of Mental Health, Az.USL Bologna, Bologna; Mirella Ruggeri, MD,
UOC Psichiatria, Azienda Ospedaliera Universitaria Integrata (AOUI), Verona and
Department of Neurosciences, Biomedicine and Movement Sciences, Section of
Psychiatry, University of Verona, Verona, Italy
Correspondence: Antonio Lasalvia, U.O.C. Psichiatria, Azienda Ospedaliera
Universitaria Integrata (AOUI), Policlinico G.B. Rossi, P.le Scuro, 10 37134
Verona, Italy. Email: antonio.lasalvia@univr.it
First received 4 Jul 2016, final revision 15 Nov 2016, accepted 19 Dec 2016
348
Funding
Ministry of Health, Italy Ricerca Sanitaria Finalizzata, Code H61J08000200001.
Acknowledgements
We are grateful to the patients and their family members who participated in this study.
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Data supplement to Lasalvia et al. Predictors and moderators of treatment outcome in
patients receiving multi-element psychosocial intervention for early psychosis: results
from the GET UP pragmatic cluster randomised controlled trial. Br J Psychiatry doi:
10.1192/bjp.bp.116.190058

2 The GET UP Group

8 Table DS1 Potential predictors/moderators of treatment outcome

1
 THE GET UP GROUP includes:

GET UP - Genetics, Endophenotypes, Treatment: Understanding early Psychosis

NationalCoordinator:Professor Mirella Ruggeri (Verona)

Leading Project: PPIIAANNO

O (Psychosis: Early Intervention and Assessment of Needs and Outcome)
Scientific Coordinator: Mirella Ruggeri (Verona)
Administrative Leading Institution: Azienda Ospedaliera Universitaria Integrata Verona, Regione
Veneto
Coordinating Centre: Mario Ballarin, Maria Elena Bertani, Sarah Bissoli, Chiara Bonetto, Doriana
Cristofalo, Katia De Santi, Antonio Lasalvia, Silvia Lunardi, Valentina Negretto, Sara Poli, Sarah
Tosato, Maria Grazia Zamboni

Project TRUMPET (TRaining and Understanding of Service Models for Psychosis Early Treatment)
Scientific Coordinator: Giovanni De Girolamo (Bologna and Brescia)
Administrative Leading Institution: Agenzia Sanitaria e Sociale Regionale, Regione Emilia
Romagna
Coordinating Centre: Angelo Fioritti, Giovanni Neri, Francesca Pileggi, Paola Rucci

Project GUITAR (Genetic data Utilization and Implementation of Targeted Drug Administration
_in the Clinical Routine)
Scientific Coordinator: Massimo Gennarelli (Brescia)
Administrative Leading Institution: IRCCS Centro S.Giovanni di Dio Fatebenefratelli, Brescia
Coordinating Centre: Luisella Bocchio Chiavetto, Catia Scasselatti, Roberta Zanardini

Project CONTRABASS
COgnitive Neuroendophenotypes for Treatment and RehAbilitation of psychoses: Brain imaging,
InflAmmation and StreSS
Scientific Coordinator: Paolo Brambilla (Udine and Verona)
Administrative Leading Institution: Azienda Ospedaliera Universitaria Integrata, Verona, Regione
Veneto
Coordinating Centre: Marcella Bellani, Alessandra Bertoldo, Veronica Marinelli, Cinzia Perlini,
Gianluca Rambaldelli

2
ENROLLMENT AND TREATMENT RESEARCH UNITS:
RESEARCH UNIT Western Veneto:
Coordinator: Antonio Lasalvia (Verona).
Administrative Leading Institution: Azienda Ospedaliera Universitaria Integrata, Verona.
Coordinating Centre: Mariaelena Bertani, Sarah Bissoli, Lorenza Lazzarotto.
Participating MHCs: TAU Arm: Ulss 3 (Bassano), Ulss 4 Alto Vicentino (Thiene), Ulss 5 Montecchio
(Centro; Sud), Ulss 6 Vicenza ( Secondo), Ulss 18 Rovigo (Rovigo), Ulss 20 Verona ( II Servizio), Ulss 22
Bussolengo (Isola della Scala).
Experimental Arm: Ulss 5 Montecchio (Nord), Ulss 6 Vicenza (Primo; Noventa), Ulss 18 Rovigo ( Badia),
Ulss 19 Adria (Adria), Ulss 20 Verona (I Servizio; III Servizio; La Filanda),Ulss 21 Legnago (Il Tulipano; il
Girasole).
MHCs Reference Persons: Sonia Bardella, Francesco Gardellin, Dario Lamonaca, Antonio Lasalvia, Marco
Lunardon, Renato Magnabosco, Marilena Martucci, Stylianos Nicolau Francesco Nifosi, Michele
Pavanati, Massimo Rossi, Carlo Piazza, Gabriella Piccione, Annalisa Sala, Benedetta Stefani, Spyridon
Zotos.
CBT Staff: Mirko Balbo, Ileana Boggian, Enrico Ceccato, Rosa DallAgnola, Francesco Gardellin, Barbara
Girotto, Claudia Goss, Dario Lamonaca, Antonio Lasalvia, Alessia Mai, Annalisa Pasqualini, Michele
Pavanati, Carlo Piazza, Gabriella Piccione, Stefano Roccato, Alberto Rossi, Spyridon Zotos.
Family Intervention Staff: Flavia Aldi, Barbara Bianchi, Paola Cappellari, Raffaello Conti, Laura De Battisti,
Silvia Merlin,. Tecla Pozzan, Lucio Sarto.
Case Management Staff: Andrea Brazzoli, Antonella Campi, Roberta Carmagnani, Sabrina Giambelli,
Annalisa Gianella, Lino Lunardi, Davide Madaghiele, Paola Maestrelli, Lidia Paiola, Elisa Posteri, Loretta
Viola, Valentina Zamberlan, Marta Zenari.
Biological Sample processing and support to Brain Imaging precedures: Sarah Tosato, Martina Zanoni,
Giovanni Bonadonna, Mariacristina Bonomo.

RESEARCH UNIT Eastern Veneto:

Coordinator: Paolo Santonastaso.
Administrative Leading Institution: University of Padua.
Coordinating Centre: Carla Cremonese, Paolo Scocco, Angela Veronese.
Participating MHCs: TAU Arm: Ulss 8 ( Castelfranco), Ulss 9 (Treviso Nord; Oderzo), Ulss 10 (San Don di
Piave), Ulss 12 (Venezia; Mestre sud), Ulss 13 (Dolo), Ulss 14 (Piove di Sacco), Ulss 15 ( Cittadella), Ulss
16 (II Servizio), Ulss 17 (Este; Montagnana).
Experimental Arm: Ulss 8 (Montebelluna; Valdobbiadene), Ulss 9 (Treviso; Mogliano Veneto), Ulss 10
(PortogReserach Unitaro), Ulss 12 (Mestre Centro), Ulss 13 (Mirano), Ulss 14 (Chioggia I; Cavarzere),
Ulss 15 (Camposanpiero), Ulss 16 (I Srvizio; III Servizio), Ulss 17 (Monselice; Conselve).
MHCs Reference Persons: Patrizia Anderle, Andrea Angelozzi, Isabelle Amalric Gabriella Baron,, Enrico
Bruttomesso Fabio Candeago, Franco Castelli, Maria Chieco, Carla Cremonese, Enrico Di Costanzo,
Mario Derossi, Michele Doriguzzi, Osvaldo Galvano, Marcello Lattanzi, Roberto Lezzi, Marisa Marcato,
Alessandro Marcolin, Franco Marini, Stefano Marino, Manlio Matranga, Elisabetta Sabbadin, , Rossana
Riolo, Maria Zucchetto, Flavio Zadro.
CBT Staff: Daniela Argenti, Giovanni Austoni, Maria Bianco, Stefania Bordino, Linda Cibiniel, Maria Chieco,
Marco DallAsta, Filippo Dario, Francesca Dassi, Alessandro Di Risio, Aldo Gatto, Simona Gran,
Emanuele Favero, Anna Franceschini, Silvia Friederici, Vanna Marangon, Marisa Marcato, Stefano
Marino, Giorgio Martinelli, Michela Pascolo, Maya Piaia, Luana Ramon, Elisabetta Sabbadin, Paolo
Scocco, Mara Semenzin, Angela Veronese, Stefania Zambolin, Maria Zucchetto. Anna Dominoni.
Family Intervention Staff: Antonella Buffon, Carla Cremonese, Elena Di Bortolo, Silvia Friederici, Stefania
Fortin,Marisa Marcato, Francesco Matarrese, Simona Mogni, Novella Nicodemo, Alessio Russo,
Alessandra Silvestro, Elena Turella, Paola Viel.

3
Case Management Staff: Lorenzo Andreose, Mario Boenco, Daniela Bottega, Loretta Bressan, Arianno
Cabbia, Elisabetta Canesso, Romina Cian, Caludia Dal Piccol, Maria Dalla Pasqua, Cinzia De Gasperi,
Anna Di Prisco, Lorena Mantellato, Monica Luison, Sandra Morgante, Mirna Santi, Moreno Sacillotto,
Mauro Scabbio, Patrizia Sponga, MLuisa Sguotto, Flavia Stach, MGrazia Vettorato.
Biological Sample processing and support to Brain Imaging precedures: Oscar Cabianca, Amalia Valente,
Livio Caberlotto, Alberto Passoni, Patrizia Flumian, Luigino Daniel, Massimo Gion, Saverio Stanziale,
Flora Alborino, Vladimiro Bortolozzo, Lucio Bacelle, Leonarda Bicciato, Daniela Basso, Filippo Navaglia,
Fabio Manoni, Mauro Ercolin.

RESEARCH UNIT Emilia:

Coordinators: Giovanni Neri, Franco Giubilini.
Administrative Leading Institution: Azienda ULSS, Parma
Coordinating Centre: Massimiliano Imbesi, Emanuela Leuci, Fausto Mazzi, Enrico Semrov.
Participating MHCs: TAU Arm: Piacenza (Castel S.Giovanni), Parma (Parma Est; Sud Est; Valli Taro e
Ceno), Reggio Emilia (CastelNovo nei Monti; Montecchio), Modena (Mirandola; Polo Ovest; Sassuolo;
Pavullo).
Experimental Arm: Piacenza (Piacenza; Fiorenzuola), Parma (Nord; Ovest; Fidenza), Reggio Emilia
(Correggio; Guastalla; Reggio Emilia III; Reggio Emilia; Scandiano), Modena ( Carpi; Polo Est; Vignola).
MHCs Reference Persons: Silvio Anelli, Mario Amore, Laura Bigi, Welsch Britta, Giovanna Barazzoni Anna,
Rubes Bonatti, Maria Borziani, Stefano Crosato, Isabella Fabris, Raffaele Galluccio, Margherita Galeotti,
Mauro Gozzi, Vanna Greco, Emanuele Guagnini, Stefania Pagani, Silvio Maccherozzi, Raffaello Malvasi,
Francesco Marchi, Ermanno Melato, Elena Mazzucchi, Franco Marzullo, Pietro Pellegrini, Nicoletta
Petrolini, Donatella Silvia Rizzi, Paolo Volta.
CBT Staff: Silvio Anelli, Franca Bonara, Elisabetta Brusamonti, Roberto Croci, Ivana Flamia, Francesca
Fontana, Romina Losi, Fausto Mazzi, Roberto Marchioro, Stefania Pagani, Luigi Raffaini, Luca Ruju,
Antonio Saginario, Giulia Stabili, Grazia Tondelli.
Family Intervention Staff: Lucia Bernardelli, Federica Bonacini, Annaluisa Florindo, Marina Merli, Patrizia
Nappo, Lorena Sola, Ornella Tondelli, Matteo Tonna, MTeresa Torre, Morena Tosatti, Gloria Venturelli,
Daria Zampolli.
Case Management Staff: Antonia Bernardi, Cinzia Cavalli, Lorena Cigala, Cinzia Ciraudo, Antonia Di Bari,
Lorena Ferri, Fabiana Gombi, Sonia Leurini, Elena Mandatelli, Stefano Maccaferri, Mara Oroboncoide,
Barbara Pisa, Cristina Ricci.
Biological Sample processing and support to Brain Imaging precedures: Enrica Poggi, Mara
Oroboncoide, Corrado Zurlini, Monica Malpeli, Rossana Colla, Elvira Teodori, Luigi Vecchia, Rocco
D'Andrea, Tommaso Trenti , Paola Paolini

RESEARCH UNIT Romagna:

Coordinators: Francesca Pileggi, Daniela Ghigi.
Administrative Leading Institution: Azienda ULSS, Rimini
Coordinating Centre: Mariateresa Gagliostro , Michela Pratelli, Paola Rucci
Participating MHCs: TAU Arm: Bologna (Zanolini; Scalo; Casalecchio; Vergato; San Giovanni), Ferrara (CSA
Ferrara; SIPI Ferrara Sud; Codigoro; Portomaggiore), Ravenna (Ravenna; Fenza), Forl (Forl), Cesena
(Cesena), Rimini (Riccione).
Experimental Arm: Bologna (Mazzacorati; Tiarini, Nani; S. Lazzaro; Budrio; San Giorgio), Imola
(UOT_Imola), Ferarra (Copparo; Ferrara Nord; Cento), Ravenna (Lugo), Cesena (Rubicone), Rimini
(Rimini).
MHCs Reference Persons: Antonio Antonelli, Luana Battistini, Francesca Bellini, Eva Bonini, Caterina
Bruschi Rossella Capelli, Cinzia Di Domizio, Chiara Drei, Giuseppe Fucci, Alessandra Gualandi, Maria
Rosaria Grazia, Anna M. Losi, Franca Mazzanti Paola Mazzoni, Daniela Marangoni, Giuseppe Monna,

4
 Marco Morselli, Alessandro Oggioni, Silvio Oprandi, Walter Paganelli, Morena Passerini, Maria Piscitelli,
Gregorio Reggiani, Gabriella Rossi, Federica Salvatori, Simona Trasforini, , Carlo Uslenghi, Simona
Veggetti,
CBT Staff: Giovanna Bartolucci, Rosita Baruffa, Francesca Bellini, Raffaella Bertelli, Lidia Borghi, Patrizia
Ciavarella, Cinzia DiDomizio, Giuseppe Monna, Alessandro Oggioni, Elisabetta Paltrinieri, Maria
Piscitelli, Francesco Rizzardi, Piera Serra, Damiano Suzzi, Uslenghi Carlo.

Family Intervention Staff: Paolo Arienti, Fabio Aureli, Rosita Avanzi, Vincenzo Callegari, Alessandra
Corsino, Paolo Host, Rossella Michetti, Michela Pratelli,Francesco Rizzo, Paola Simoncelli, Elena Soldati,
Eraldo Succi.
Case Management Staff: Massimo Bertozzi, Elisa Canetti,Luca Cavicchioli, Elisa Ceccarelli, Stefano Cenni,
Glenda Marzola, Vanessa Gallina, Carla Leoni, Andrea Olivieri, Elena Piccolo, Sabrina Ravagli, Rosaria
Russo, Daniele Tedeschini.
Biological Sample processing and support to Brain Imaging precedures: Marina Verenini, Walter Abram,
Veronica Granata, Alessandro Curcio, Giovanni Guerra, Samuela Granini, Lara Natali, Enrica Montanari,
Fulvia Pasi, Umbertina Ventura, Stefania Valenti, Masi Francesca, Rossano Farneti, Paolo Ravagli,
Romina Floris, Otello Maroncelli, Gianbattista Volpones, Donatella Casali.

RESEARCH UNIT Firenze:

Coordinator: Maurizio Miceli.
Administrative Leading Institution: Azienda Sanitaria di Firenze
Coordinating Centre: Maurizio Miceli.
Participating MHCs: TAU Arm: MOM SMA 5; MOM SMA 8; MOM SMA 11; MOM SMA 12.
Experimental Arm: MOM SMA 3; MOM SMA 7; MOM SMA 9; MOM SMA 10.
MHCs Reference Persons: Andrea Bencini, Massimo Cellini, Luca De Biase, Leonardo Barbara, Liedl
Charles, Maurizio Miceli, Cristina Pratesi, Andrea Tanini, Roberto Leonetti.
CBT Staff: Massimo Cellini, Maurizio Miceli, Riccardo Loparrino, Cristina Pratesi, Cinzia Ulivelli,
Family Intervention Staff: Cristina Cussoto, Nico Dei, Enrico Fumanti, Manuela Pantani, Gregorio Zeloni.
Case Management Staff: Rossella Bellini, Roberta Cellesi, Nadia Dorigo, Patrizia Gull, Luisa Ialeggio,
Maria Pisanu.
Biological Sample processing and support to Brain Imaging precedures: Graziella Rinaldi, Angela Konze

RESEARCH UNIT Milano Niguarda:

Coordinator: Angelo Cocchi.
Administrative Leading Institution: Azienda Ospedaliera Ospedale Niguarda Ca Granda, Milano
Coordinating Centre: Anna Meneghelli
Participating MHCs: TAU Arm: corso Plebisciti; via Mario Bianco.
Experimental Arm: via Cherasco e via Livigno; via Litta Modignani.
MHC Reference Persons: Maria Frova , Emiliano Monzani, Alberto Zanobio, Marina Malagoli, Roberto
Pagani.
CBT Staff: Simona Barbera, Carla Morganti, Emiliano Monzani, Elisabetta Sarzi Amad.
Family Intervention Staff: Virginia Brambilla, Anita Montanari.
Case Management Staff: Giori Caterina, Carmelo Lopez.
Biological Sample processing and support to Brain Imaging precedures: Alessandro Marocchi, Andrea
Moletta, Maurizio Sberna

RESEARCH UNIT Milano S. Paolo:

Coordinator: Silvio Scarone.
5
 Administrative Leading Institution: Azienda ULSS San Paolo, Milano
Coordinating Centre: Maria Laura Manzone
Participating MHCs: TAU Arm: CPS Zona 14 (Barabino).
Experimental Arm: Rozzano; Zona 15 (Conca del Naviglio); Zona 16 (San Vigilio).
MHC Reference Persons: Barbera Barbara, Luisa Mari, Maria L. Manzone, Edoardo Razzini.
CBT Staff: Yvonne Bianchi, MRosa Pellizzer, Antonella Verdecchia.
Family Intervention Staff: MGabriella Sferrazza, MLaura Manzone, Carmine Pismataro.
Case Management Staff: Benedetta Cerrai, Alessandra Gambino, Rosa Panarello.
Biological Sample processing and support to Brain Imaging precedures: Gian Vico Melzi D'Eril,
Alessandra Barassi, Rosana Pacciolla, Gloria Faraci

RESEARCH UNIT Bolzano:

Coordinator: Stefano Torresani (Bolzano).
Administrative Leading Institution: Azienda Sanitaria,, Bolzano
Participating MHCs: TAU Arm: none
Experimental Arm: Bolzano Rossini; Bolzano del Ronco.
MHC Reference Persons: Fabio Carpi, Soelva Margit.
CBT Staff: Monica Anderlan, Michele De Francesco, Efi Duregger, Stefano Torresani, Carla Vettori.
Family Intervention Staff: Carpi Fabio, Doimo Sabrina, Kompatscher Erika, Soelva Margit, Stefano
Torresani
Case Management Staff: Forer Michael, Kerschbaumer Helene.
Biological Sample processing and support to Brain Imaging precedures: Anna Gamper, Maira Nicoletti

PSYCHOTHERAPISTS SUPPORTING TREATMENTS IN THE EXPERIMENTAL ARM:

Chiara Acerbi, Daniele Aquilino, Silvia Azzali, Luca Bensi, Sarah Bissoli, Davide Cappellari, Elisa Casana,
Nadia Campagnola, Elisa Dal Corso, Elisabetta Di Micco, Erika Gobbi, Laura Ferri, Erika Gobbi, Laura
Mairaghi, Sara Malak, Luca Mesiano, Federica Paterlini, Michela Perini, Elena Maria Puliti, Rosaria Rispoli,
Elisabetta Rizzo, Chiara Sergenti, Manuela Soave, Elisabetta Di Micco, Rosaria Rispoli.

EXPERTS SUPERVISING TREATMENTS IN THE EXPRERIMENTAL ARM:

Andrea Alpi, Laura Bislenghi, Tiziana Bolis, Francesca Colnaghi, Simona Fascendini, Silvia Grignani, Anna
Meneghelli, Giovanni Patelli.

SPECIFIC TOPICS RESEARCH UNITS:

RESEARCH UNIT Life Events Firenze - Coordinator: Carlo Faravelli
Coordinating Centre: Silvia Casale
Administrative Leading Institution: University of Florence

RESEARCH UNIT Communications Skills - Coordinator: Christa Zimmermann

Coordinating Centre: Giuseppe Deledda, Claudia Goss, Mariangela Mazzi, Michela Rimondini.
Administrative Leading Institution: University of Verona

RESEARCH UNIT Genetics-IRCCS, FBF Brescia Coordinator: Massimo Gennarelli

Coordinating Centre: Catia Scassellati, Cristian Bonvicini, Sara Longo
Administrative Leading Institution: IRCCS Centro S.Giovanni di Dio Fatebenefratelli, Brescia

6
 RESEARCH UNIT Neuropsicopharmacology-IRCCS, FBF Brescia Coordinator: Luisella Bocchio Chiavetto
Coordinating Centre: Roberta Zanardini
Administrative Leading Institution: IRCCS Centro S.Giovanni di Dio Fatebenefratelli, Brescia

RESEARCH UNIT Molecular Biology, AFaR, FBF, Roma Coordinator: Mariacarla Ventriglia
Coordinating Centre: Rosanna Squitti
Administrative Leading Institution: Department of Neuroscience, AFaR-Fatebenefratelli Hospital, Rome,
Italy

RESEARCH UNIT LENITEM - IRCCS, FBF Brescia Coordinator: Giovanni Frisoni

Coordinating Centre: Michela Pievani
Administrative Leading Institution: IRCCS Centro S.Giovanni di Dio Fatebenefratelli, Brescia

RESEARCH UNIT RUBIN, Udine-Verona Coordinator: Matteo Balestrieri

Coordinating Centre: Paolo Brambilla, Cinzia Perlini, Veronica Marinelli, Marcella Bellani, Gianluca
Rambaldelli, Alessandra Bertoldo, Paolo Carpeggiani, Alberto Beltramello, Franco Alessandrini,
Francesca Pizzini, Giada Zoccatelli, Maurizio Sberna, Angela Konze
Administrative Leading Institution: DISM, Universit di Udine, Udine (Mrs Marina Dorligh)

RESEARCH UNIT STRESS, University of Pavia Coordinator: Pierluigi Politi

Coordinating Centre: Enzo Emanuele, Natascia Brondino.

RESEARCH UNIT Neuroimmunologiy-IRCCS S. Raffaele, Milano Coordinator: Gianvito Martino

Coordinating Centre: Alessandra Bergami e Roberto Zarbo

RESEARCH UNIT Animal Models, Univ. Milano Coordinator: Marco Andrea Riva

Coordinating Centre: Fabio Fumagalli, Raffaella Molteni, Francesca Calabrese, Gianluigi Guidotti,
AlessiaLuoni, Flavia Macchi.

INDEPENDENT EVALUATORS AND RESEARCHERS SUPPORTING THE ONSITE DATA COLLECTION:

Stefania Artioli, Marco Baldetti, Milena Bizzocchi, Donatella Bolzon, Elisa Bonello, Giorgia Cacciari, Claudia
Carraresi, MTeresa Cascio, Gabriele Caselli, Karin Furlato, Sara Garlassi, Alessandro Gavarini, Silvia
Lunardi, Fabio Macchetti, Valentina Marteddu, Giorgia Plebiscita, Sara Poli, Stefano Totaro.

FAMILIES AND USERS ASSOCIATION (AITSAM):

Tali Corona Mattioli

INTERNATIONAL ADVISORY BOARD:

PIANO: Paul Bebbington, Max Birchwood, Paola Dazzan, Elisabeth Kuipers, Graham Thornicroft;
GUITAR: Carmine Pariante; CONTRABASS: Steve Lawrie, Carmine Pariante, Jair C. Soares

7
Table DS1 Potential predictors/moderators of treatment outcome (experimental treatment group,
n=272; TAU group, n=172).

BASELINE (after clinical

stabilisation)
Treatment as Experimental P-value
usual group treatment (Chi-square or
(n=172) group t-test, where
(n=272) appropriate)
Age at first contact with services, mean
(s.d.) 31.5 (9.2) 29.3 (9.8) 0.017
<35 years, n (%) 106 (61.6%) 194 (71.3%) 0.033
35 years, n (%) 66 (38.4%) 78 (28.7%)
Gender, n (%)
Male 94 (54.7%) 166 (61.0%) 0.184
Female 78 (45.3%) 106 (39.0%)
Citizenship, n (%)
Italy 149 (86.6%) 241 (88.6%) 0.535
Other 23 (13.4%) 31 (11.4%)
Education, n (%) (13 missing) (9 missing)
Low (primary-middle school) 68 (42.8%) 95 (36.1%) 0.174
High (secondary school, university) 91 (57.2%) 168 (63.9%)
Duration of Untreated Psychosis DUP (30 missing) (31 missing)
(months), mean (s.d.) 7.7 (18.3) 7.4 (17.6) 0.870
Insight SAI, mean (s.d.) (60 missing) (55 missing)
Attribution of Symptoms 5.72 (3.30) 5.41 (3.27) 0.457
Illness Awareness 8.12 (1.64) 7.67 (1.71) 0.121
Treatment Adherence 4.24 (1.73) 3.78 (1.89) 0.032
Type of Psychosis, n (%)
Non-affective psychosis 132 (76.7%) 214 (78.7%) 0.632
Affective psychosis 40 (23.3%) 58 (21.3%)
Premorbid Social Adjustment PAS, mean (70 missing) (62 missing)
(s.d.)
Social Childhood 1.50 (1.22) 1.62 (1.30) 0.433
School Childhood 1.35 (1.00) 1.31 (1.11) 0.752
Social Adolescence 2.00 (1.43) 2.05 (1.44) 0.785
School Adolescence 1.98 (1.77) 1.83 (1.36) 0.389

8
Predictors and moderators of treatment outcome in patients
receiving multi-element psychosocial intervention for early
psychosis: results from the GET UP pragmatic cluster
randomised controlled trial
Antonio Lasalvia, Chiara Bonetto, Jacopo Lenzi, Paola Rucci, Laura Iozzino, Massimo Cellini, Carla
Comacchio, Doriana Cristofalo, Armando D'Agostino, Giovanni de Girolamo, Katia De Santi, Daniela
Ghigi, Emanuela Leuci, Maurizio Miceli, Anna Meneghelli, Francesca Pileggi, Silvio Scarone, Paolo
Santonastaso, Stefano Torresani, Sarah Tosato, Angela Veronese, Angelo Fioritti, Mirella Ruggeri and
the GET UP Group
BJP 2017, 210:342-349.
Access the most recent version at DOI: 10.1192/bjp.bp.116.190058

Supplementary Supplementary material can be found at:

Material http://bjp.rcpsych.org/content/suppl/2017/03/06/bjp.bp.116.190058.DC1

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