A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis (GETUP-PIANO)
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%.
|Psychosis||Other: Treatment As Usual (TAU) Behavioral: TAU+CBT for pts+Family Intervention+CM.|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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 and Effectiveness: GET UP-PIANO Trial|
- 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
- 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
|Study Start Date:||April 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Treatment As Usual (TAU)||
Other: Treatment As Usual (TAU)
Services participating in the trial are routine public Community Mental Health Centres (CMHCs), which operate within the Italian National Health Service. Multi-disciplinary teams operating these CMHCs provide a wide range of integrated programmes, including inpatient care, day care, rehabilitation, outpatient care, home visits, 24-hour emergency services, and residential facilities. Standard care for FEP patients generally consists of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management at the CMHC level. Family interventions generally consist of non-specific informal support/educational sessions. Both specialized individual psychotherapeutic interventions for patients (included CBT) and specialized psycho-educational or cognitive-oriented family interventions are usually not provided, due to lack of trained professionals.
|Experimental: TAU+CBT for pts+Family Intervention+CM||
Behavioral: TAU+CBT for pts+Family Intervention+CM.
The experimental treatment package is administered by the CMHC staff, after training and with ongoing supervision by experts. Cognitive-behavioural therapy (CBT) is based on the model developed by Kuipers in 1998 and Garety in 2008. A total of 20-30 CBT sessions per patient will be delivered, with weekly sessions during months 1-3 and fortnightly over the following 6 months. Family Intervention is based on the model proposed by Leff in 1982 and further developed by Kuipers in 2002. It includes a total of 10-15 sessions with each individual family: 6 in months 1-3, and at least 1 session/month in the 6 months afterwards. Every patient/family will have a dedicated Case Manager, who will coordinate all planned interventions. Specific training programs have been developed, with assessment of the staff competence. Detailed Manuals based on international standards have been developed and will be used. Fidelity will be measured at the end of the trial.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01436331
|University of Verona - Section of Psychiatry and Clinical Psychology, Department of Public Health and Community Medicine|
|Verona, Italy, 37134|
|Principal Investigator:||Mirella RUGGERI, M.D.||Universita' di Verona|