Status:
COMPLETED
A Large Pragmatic Cluster Randomized Controlled Trial of a Multi-element Psychosocial Intervention for Early Psychosis
Lead Sponsor:
Universita di Verona
Conditions:
Psychosis
Eligibility:
All Genders
18-54 years
Phase:
NA
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 th...
Detailed Description
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" pe...
Eligibility Criteria
Inclusion
- age 18-54 yrs
- residence in the catchment area of participating Community Mental Health Centres
- presence of (a) at least 1 of the following symptoms: hallucinations, delusions, qualitative speech disorder, qualitative psychomotor disorder, bizarre or grossly inappropriate behavior, or (b) at least 2 of the following symptoms: loss of interest, initiative and drive, social withdrawal, episodic severe excitement, purposeless destructiveness, overwhelming fear, marked self-neglect
- first lifetime contact with participating CMHC, occasioned by symptoms enumerated in 3.
- clinical ICD-10 diagnosis of F20-29; F30.2, F31.2, F31.5, F31.6, F32.3, F33.3, F1x.4; F1x.5; F1x.7;F20-F29, as confirmed after 6 months by using the Schedule for Clinical Assessment in Neuropsychiatry (WHO SCAN)
Exclusion
- prior anti-psychotic medication (\> 3 months) provided by any psychiatric or other medical agencies
- mental disorders due to a general medical condition
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT01436331
Start Date
April 1 2010
End Date
May 1 2012
Last Update
January 8 2013
Active Locations (1)
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1
University of Verona - Section of Psychiatry and Clinical Psychology, Department of Public Health and Community Medicine
Verona, Italy, 37134