Extended Specialized Assertive Intervention for First Episode Psychosis

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia; First Episode Psychosis of Schizophrenia and Schizotypal Disorder; Psychotic Disorders
• Interventions: Behavioral: OPUS 5 years; Behavioral: 2 years OPUS treatment

• Registration Number: NCT00914238
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Start: 2009-07
• Primary Completion: 2015-06
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 year	OPUS 5 years	5 years OPUS treatment
2 years of OPUS treatment	2 years OPUS treatment	2 years OPUS treatment and 3 years of treatment as usual

Primary Outcome Measures

Name	Time	Method
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)	3 years

Secondary Outcome Measures

Name	Time	Method
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
Simultaneous remission of both psychotic and negative symptoms.	3 years
Psychotic symptoms	3 years

Trial Locations

Locations (2)

Psychiatric Center Bispebjerg; 🇩🇰 Copenhagen, Denmark

Psychiatric Centre Bispebjerg; 🇩🇰 Copenhagen, Denmark