Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* 18-45 years of age
* F2 diagnosis in ICD 10
* Address in Copenhagen, Frederiksberg or Aarhus
* Antipsychotic medication not exceeding 12 weeks
* Informed consent

Exclusion Criteria:
B: Inclusion Criteria:

* Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:

  * schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS
* Any duration of untreated psychosis
* Any ethnicity
* Ability to participate in research assessments in English
* Ability to provide fully informed consent (assent for those under age 18)

Exclusion Criteria:

* Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent
* More than 4 months of prior cumulative treatment with antipsychotic medications
* Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder
* Current psychotic disorder due to a general medical condition
* Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion
* Clinically significant head trauma
* Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial
C: Inclusion Criteria:

1. age 18-54 yrs
2. residence in the catchment area of participating Community Mental Health Centres
3. 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
4. first lifetime contact with participating CMHC, occasioned by symptoms enumerated in 3.
5. 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 Criteria:

1. prior anti-psychotic medication (\> 3 months) provided by any psychiatric or other medical agencies
2. mental disorders due to a general medical condition
D: Inclusion Criteria:

* patients aged 18 - 37 years
* first episode psychosis in schizophrenia spectrum
* treated for 1½ year in the five OPUS teams in the Capital Region and the OPUS teams in Region Midt
* patients who will give signed informed consent to participate in the trial

Exclusion Criteria:

* patients who are not treated in one of the OPUS team in the Capital Region and Region Midt
* patients who don't give signed informed consent to participate in the study

Answer: C