OPUSII: Extended Specialized Assertive Intervention for First Episode Psychosis

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00914238

Collaborator

Mental Health Centre Copenhagen (Other), Region Capital Denmark (Other), Medical Research Council (Other), Aarhus University Hospital (Other)

400

Enrollment

Locations

Arms

Duration (Months)

200

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
First Episode Psychosis of Schizophrenia and Schizotypal Disorder Psychotic Disorders Schizophrenia Schizoaffective Disorder	Behavioral: 2 years OPUS treatment Behavioral: OPUS 5 years	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5 year 5 years OPUS treatment	Behavioral: OPUS 5 years
Active Comparator: 2 years of OPUS treatment 2 years OPUS treatment and 3 years of treatment as usual	Behavioral: 2 years OPUS treatment 2 years OPUS and transfer to standard treatment.

Arm

Intervention/Treatment

Experimental: 5 year

5 years OPUS treatment

Behavioral: OPUS 5 years

Active Comparator: 2 years of OPUS treatment

2 years OPUS treatment and 3 years of treatment as usual

Behavioral: 2 years OPUS treatment

2 years OPUS and transfer to standard treatment.

Outcome Measures

Primary Outcome Measures

Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) [3 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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