Extended Specialized Assertive Intervention for First Episode Psychosis

Study Overview
=================
Brief Summary
-----------------
In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.

Detailed Description
-----------------
The Danish OPUS I trial succeeded in randomizing 547 patients with first-episode psychosis to a two-year specialized intensive treatment program (OPUS) or standard treatment. The results clearly favored OPUS treatment, and psychotic and negative symptoms, substance abuse, adherence to treatment, use of anti-psychotic medication, user satisfaction, and use of bed days were better in OPUS compared to standard treatment. However, the five-year follow-up, three years after patients from OPUS were transferred to standard treatment, showed that the positive clinical effects were not sustained, when the intensive treatment was terminated, except from OPUS-patients being less likely to stay in institutions than patients who received standard care. Objective: The aim in OPUS II trial is to compare the effect of five-years versus two-years specialized assertive intervention program (OPUS-treatment) for first episode psychosis on clinical symptoms, substance abuse, institutionalization, and labor market affiliation. Hypothesis: It is possible to maintain the positive results of the intensive two-year intervention in another three years for those who keep receiving the specialized assertive intervention program. Design: Open label randomized clinical trial. Setting: Psychiatric Center Bispebjerg and Center for Psychiatric Research Aarhus, Denmark.Participants: 400 patients with first episode of schizophrenia spectrum disorder received treatment in one of the six OPUS - teams for 1½ years. Intervention: Another 3½ years OPUS-treatment versus ½ year OPUS-treatment and thereafter referral to standard treatment. The extended OPUS treatment consist modified assertive case management, rational pharmacotherapy, family psycho-educational intervention, group interventions to aid with recovery, social skills training, cognitive behavior therapy when indicated, and crisis intervention. OPUS-treatment is tailored to meet the individual patient's needs.

Official Title
-----------------
A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial

Conditions
-----------------
First Episode Psychosis of Schizophrenia and Schizotypal Disorder, Psychotic Disorders, Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: 2 years OPUS treatment
* Behavioral: OPUS 5 years


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 year<br>5 years OPUS treatment | Behavioral: OPUS 5 years<br> <br> |
| Active Comparator: 2 years of OPUS treatment<br>2 years OPUS treatment and 3 years of treatment as usual | Behavioral: 2 years OPUS treatment<br>* 2 years OPUS and transfer to standard treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic symptoms |  | 3 years | 
| Simultaneous remission of both psychotic and negative symptoms. |  | 3 years | 
| Substance abuse. |  | 3 years | 
| Suicidal behaviour. |  | 3 years | 
| Use of bed days. |  | 3 years | 
| Independent living. |  | 3 Years | 
| Labour market affiliation. |  | 3 years | 
| User satisfaction. |  | 3 years | 
| Adherence to treatment. |  | 3 years | 
| Compliance with medication |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosocial, Randomized clinical trial, first episode psychosis of schizophrenia and schizotypal disorder, rehabilitation, health service research, schizotypal Disorder