Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants

Abstract

Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services.

Structural Brain Abnormalities in Youth With Psychosis Spectrum Symptoms

“…4–7 A better understanding of the developmental antecedents of psychosis may lead to both early identification and novel targeted interventions. 8–10 …”

Cost-Effectiveness of Comprehensive, Integrated Care for First Episode Psychosis in the NIMH RAISE Early Treatment Program

“…Research suggests that early intervention for psychotic disorders such as schizophrenia can improve outcomes, [1][2][3][4][5] and 2 cluster randomized trials 6,7 have demonstrated effectiveness in routine service settings. One unanswered question is whether the increased costs of comprehensive first episode psychosis (FEP) programs are offset by reduced inpatient costs, or whether the value of health benefits justifies the additional costs.…”

Development and Testing of the First-Episode Psychosis Services Fidelity Scale

“…We determined that there was sufficient evidence to develop a scale that is based on the evidence for the effectiveness of individual components of FEPS and on evidence from robust large-scale randomized controlled trials of the effectiveness of FEPS (9)(10)(11)(12). In contrast to a scale developed from a single effective program, a scale that is derived from a comprehensive review of the literature can be more easily applied to a broad range of programs.…”