A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
5 year
5 years OPUS treatment
干预措施: OPUS 5 years (Behavioral)
2 years of OPUS treatment
2 years OPUS treatment and 3 years of treatment as usual
干预措施: 2 years OPUS treatment (Behavioral)
结局指标
主要结局
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
时间窗: 3 years
次要结局
- 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)
研究者
Merete Nordentoft, Professor, DMSc.
Professor
Mental Health Services in the Capital Region, Denmark