Clinical Trial: A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

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'

Detailed Summary:

BACKGROUND. It has been shown that most clinical and psychosocial deterioration in psychosis occurs within the first 5 years of illness onset, suggesting thereby that this timeframe is a "critical" period for initiating treatment. Research has therefore more recently focused on early detection and intervention for psychosis, showing that the beneficial effects of antipsychotic medication on first-episode psychosis (FEP) are tempered by the fact that, despite initial symptom reduction, functional recovery is typically poor, even when optimal pharmacological treatment is provided. Family members suffer due to the high emotional burden of being caregivers and frequently show signs of psychological distress. Over the last few years, there has been a growing interest in psychosocial intervention as a means of facilitating recovery and reducing long-term disability associated with psychosis. Literature on psychosocial interventions in FEP can be viewed in terms of two broad categories: 1) studies evaluating specific (i.e. single-element) psychosocial interventions (e.g. individual cognitive behavioral therapy), and 2) studies evaluating comprehensive (i.e. multi-element) interventions, which may include early detection strategies, individual, group, and/or family therapy, and case management (in addition to pharmacological treatment). The latter appear very promising and have been found to be associated with symptom reduction/remission, improved quality of life, increased social and cognitive functioning, low inpatient admission rates, improved insight, high degree of satisfaction with treatment, less time spent in hospital, decreased substance abuse, and fewer self- harm episodes. Most multi-element research programs, however, have been conducted on non-epidemiologically representative samples in experimental settings, raising the risk thereby of underestimating the complexities involved in treating FEP in "rea
Sponsor: Universita di Verona

Current Primary Outcome:

  • Relapses [ Time Frame: 9 months ]
    We define relapse as an episode that has resulted in an admission to a psychiatric inpatient unit (number and days of hospitalization) and/or any case noted record of increase in psychotic symptoms' severity during the study period
  • Positive and negative symptoms [ Time Frame: change from baseline at 9 month follow-up ]
    Positive and Negative symptoms will be measured by the positive and negative subscales of the PANSS and by the PSYRATS


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Service Satisfaction in patients and relatives [ Time Frame: 9 months ]
    Service satisfaction will be measured by using the Verona Service Satisfaction Scale, versions for patients and relatives
  • Patient Functioning [ Time Frame: change from baseline at 9 month follow-up ]
    Functionig will be assessed by using the Global Assessment of Functioning Scale and the WHO-Disability Assessment Scale
  • Patient emotional wellbeing [ Time Frame: change from baseline at 9 month follow-up ]
    Emotional wellbeing will be measured by using the anxiety and depression items of the PANSS and the Hamilton-D and selected items of the WHO QoL Scale
  • Service disengagement [ Time Frame: 9 months ]
    Service disengagement and time to service disengagement will be assessed by consulting case records and local databases
  • Patient Needs for care [ Time Frame: change from baseline at 9 month follow-up ]
    Needs for care will be assessed by using the Camberwell Assessment of Need scale
  • Key relative expressed emotions [ Time Frame: change from baseline at 9 month follow-up ]
    Expressed emotions will be measured by using the Level of Expressed Emotion Scale
  • Key relative burden [ Time Frame: change from baseline at 9 month follow-up ]
    Family burden will be measured by using the Involvement Evaluation Questionnaire


Original Secondary Outcome: Same as current

Information By: Universita di Verona

Dates:
Date Received: September 14, 2011
Date Started: April 2010
Date Completion:
Last Updated: January 7, 2013
Last Verified: January 2013