A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

Table 1 Study schedule: instruments used at baseline and follow-up assessments in the Genetics, Endophenotypes and Treatment: Understanding Early Psychosis (GET UP) Psychosis Early Intervention and Assessment of Needs and Outcome (PIANO) trial

	Enrolment (12 months)	Baseline	Follow-up (9 months from baseline)
Patients
Review of inclusion criteria	X
Informed consent signed	X
Consent for involvement of family members	X
Sociodemographic and clinical data		X
Instruments
Core set: PANSS, HAM-D, BRMRS, GAF, DAS		X	X
TIB, Life events (CECA-Q, PBI), neuropsychological tests (WCST, AX-CPT, WAIS)		X
CDUS, PSYRATS, SAI-E, CAN-EU, WHOQOL-Bref, LEE		X	X
LCS, VSSS-EU			X
SCAN			X
Psychosocial/pharmacological treatment/admissions schedule			X
VITreT			X
Reporting of pharmacological side-effects and other adverse events		X	X
Family members
Informed consent signed	X
IEQ-EU, GHQ		X	X
PSA		X
VSSS-Relatives			X

AX-CPT, AX-Continuous Performance Test; BRMRS, Bech-Rafaelsen Mania Rating Scale; CAN-EU, Camberwell Assessment of Needs; CDUS, Clinical Drug Use Scale; CECA-Q, Childhood Experience of Care and Abuse Questionnaire; DAS, Disability Assessment Scale; GAF, Global Assessment of Functioning; GHQ, General Health Questionnaire; HAM-D, Hamilton Rating Scale for Depression; IEQ-EU, Involvement Evaluation Questionnaire; LCS, Life Chart Schedule; LEE, Level of Expressed Emotion Scale; PANSS, Positive and Negative Syndrome Scale; PBI, Parental Bonding Instrument; PSA, Premorbid Social Adjustment; PSYRATS, Psychotic Symptom Rating Scale; SAI-E, Schedule of Assessment of Insight; SCAN, Schedule for Clinical Assessment in Neuropsychiatry; TIB, Test Intelligenza Breve (Italian version of the New Adult Reading Test); VITreT, Verona Interview for Treatment Termination; VSSS-EU, Verona Service Satisfaction Scale, patient version; VSSS-Relatives, Verona Service Satisfaction Scale, relatives version; WAIS, Wechsler Adult Intelligence Scale; WCST, Wisconsin Card Sorting Test; WHOQOL-Bref World Health Organization Quality of Life.

ISSN: 1745-6215