Extended Specialized Assertive Intervention for First Episode Psychosis (OPUS II)
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Purpose
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 | Intervention |
|---|---|
|
First Episode Psychosis Psychotic Disorders Schizophrenia Schizoaffective Disorder |
Behavioral: 5 years OPUS treatment Behavioral: 2 years OPUS treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Psychotic symptoms [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Simultaneous remission of both psychotic and negative symptoms. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Substance abuse. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Suicidal behaviour. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Use of bed days. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Independent living. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
- Labour market affiliation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- User satisfaction. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Adherence to treatment. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Compliance with medication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5 year
5 years OPUS
|
Behavioral: 5 years OPUS treatment
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.
|
|
Active Comparator: 2 year
2 years OPUS
|
Behavioral: 2 years OPUS treatment
2 years OPUS and transfer to 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.
Eligibility| Ages Eligible for Study: | 18 Years to 37 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Merete Nordentoft, Professor | +45 206 075 52 | mn@dadlnet.dk |
| Contact: Marianne Melau, nurse, MSc | 45 206 075 51 | mm21@regionh.dk |
| Denmark | |
| Psychiatric Centre Bispebjerg | Not yet recruiting |
| Copenhagen, Denmark, 2400 | |
| Psychiatric Center Bispebjerg | |
| Copenhagen, Denmark, 2400 | |
| Principal Investigator: | Merete Nordentoft, Professor | University of Copenhagen |
More Information
No publications provided by University of Copenhagen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merete Nordentoft, professor, chief physician, DMSc, PhD, MPH, Copenhagen University, Faculty of Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00914238 History of Changes |
| Other Study ID Numbers: | Danish OPUS II trial |
| Study First Received: | May 28, 2009 |
| Last Updated: | June 3, 2009 |
| Health Authority: | Denmark: The Ministry of the Interior and Health Denmark: Danish Dataprotection Agency |
Keywords provided by University of Copenhagen:
|
Randomized clinical trial first episode psychosis rehabilitation |
psychosocial health service research schizotypal Disorder |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 19, 2013