Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis in a 10 Million Inhabitant Catchment Area Aimed to Measure the Treatment's Feasibility and Effectiveness: GET UP-PIANO Trial
Brief Summary: Multi-element interventions for first-episode psychosis (FEP) are promising but have mostly been conducted on non epidemiologically representative samples in experimental settings, raising the risk thereby of underestimating the complexities involved in treating onset psychosis in "real world" services. The PIANO Trial (Psychosis early Intervention and Assessment of Needs and Outcome) is part of a more broad-based research program (Genetics, Endophenotype and Treatment: Understanding early Psychosis - GET UP) and aims to: 1) test, at 9 months, the effectiveness, as compared to treatment as usual (TAU) of multi-component psychosocial intervention on a large epidemiologically-based cohort of FEP patients and their family members recruited from a 10 million inhabitant catchment area; 2) identify barriers that may hinder its feasibility and patient/family conditions that can render this type of treatment ineffective or inappropriate; 3) identify clinical, psychological, and environmental and service predictors of treatment effectiveness in FEP.

Study participants will be recruited from Community Mental Health Centers (CMHCs) operating for the Italian National Health Service and located in several Northern and Central Regions of Italy. The GET UP PIANO Trial has a pragmatic cluster randomized controlled design, which is considered the gold standard approach for trials that evaluate complex interventions implemented at the institutional level, with the aim of improving health. The assignment units (clusters) are the CMHCs, and the units of observation and analysis are the Centers' patients and their family members.

Patients in the experimental group will receive TAU plus: (a) Cognitive-Behavioural Therapy (CBT) sessions, (b) psycho-educational sessions for family members, and c) a case manager, to serve as the patient's referent. Patient enrollment will take place over a 1 year interval, after a 3 month-long piloting. The fidelity of the experimental interventions and the characteristics of TAU will be regularly monitored. Several psychopathological, psychological, functioning and service use variables will be assessed at baseline and 9 month follow-up by independent evaluators. Assuming an expected incidence rate of 17/100.000 per year for functional psychoses (as previously estimated in Italy), the investigators expect to recruit about 800 patients, and 600 relatives. Assuming an attrition rate of about 50%, the size of the trial would detect at 9 months a difference in terms of primary outcome from 25% for the TAU arm to 10% for the intervention arm, with a power of 80%.


Options:
A: Arm Label: Individual psychoeducation; Type: EXPERIMENTAL; Interventions: Other: Individual psychoeducation | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control | Intervention Type: OTHER; Name: Control; Assigned to Arm(s): Control | Intervention Type: OTHER; Name: Individual psychoeducation; Assigned to Arm(s): Individual psychoeducation
B: Arm Label: Integrated Treatment; Type: EXPERIMENTAL; Interventions: Behavioral: Integrated Treatment | Arm Label: Community Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Community Care | Intervention Type: BEHAVIORAL; Name: Integrated Treatment; Assigned to Arm(s): Integrated Treatment | Intervention Type: BEHAVIORAL; Name: Community Care; Assigned to Arm(s): Community Care
C: Arm Label: Treatment As Usual (TAU); Type: ACTIVE_COMPARATOR; Interventions: Other: Treatment As Usual (TAU) | Arm Label: TAU+CBT for pts+Family Intervention+CM; Type: EXPERIMENTAL; Interventions: Behavioral: TAU+CBT for pts+Family Intervention+CM. | Intervention Type: OTHER; Name: Treatment As Usual (TAU); Assigned to Arm(s): Treatment As Usual (TAU) | Intervention Type: BEHAVIORAL; Name: TAU+CBT for pts+Family Intervention+CM.; Assigned to Arm(s): TAU+CBT for pts+Family Intervention+CM
D: Intervention Type: BEHAVIORAL; Name: Integrated treatment, family involvement; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Social skills training; Assigned to Arm(s): N/A

Answer: C