The RAISE (Recovery After an Initial Schizophrenia Episode) Early Treatment Program Clinical Trial was the first randomized controlled trial of multidisciplinary intervention ever conducted in multiple community settings in the USA. It compared a protocol-driven care program against the community care usually offered to people with first episode psychosis. This ground-breaking study was funded by the National Institute of Mental Health with Dr. John Kane (Zucker Hillside Hospital, Glen Oaks, New York, USA) as the principal investigator.
The study found that quality of life at two years, the primary outcome of this landmark US study, improved significantly more among patients with first episode psychosis who were given comprehensive psychosocial and pharmacological treatment than in those receiving standard community care.
Patients in the integrated intervention group were also significantly more likely than controls to be in work, school or college; more likely to stay in treatment; and they showed significantly greater symptom relief according to the Positive and Negative Syndrome Scale (PANSS) and the Calgary Depression Scale for Schizophrenia.
Coordinated care can be given in a wide range of community settings and improves the quality of life of FEP patients. But early intervention is essential.
The RAISE project involved 34 non-academic centers across 21 states in the US.
The comprehensive care package, termed NAVIGATE, had four evidence-based interventions:
- personalized medication management;
- family psycho-education;
- individual therapy focused on resilience; and
- support in employment and education
The program emphasized shared decision making centered on patient preferences. For pharmacotherapy, an expert panel developed a web-based decision support system to facilitate choice of treatment.
Medication was individualized to reduce side effects
The psychosocial interventions combined general modules – goal setting, education about psychosis, relapse prevention and processing the psychotic episode – with modules individualized to the patient. These included dealing with negative feelings and substance abuse, living healthy, and developing relationships.
Quality of life was measured by centralized physician assessors using the Heinrichs-Carpenter scale during a live, two-way video interview.
Comprehensive care did not reduce rate of hospitalization for psychiatric indications: 34% in the NAVIGATE group, 37% among controls. However, it is important to note that these rates are relatively low for first episode psychosis and reflect well on the centers randomized to the control arm.
Based on the 404 patients randomized by center, the study showed that comprehensive intervention can improve the trajectory of patients with first episode psychosis in the life domains that matter most to them and their families.
The median duration of untreated psychosis (DUP) for patients enrolled in the trial – defined as the time between onset of psychotic symptoms and the start of drug treatment – was 74 weeks. This led to a finding with profound implications for our understanding of the importance of timely intervention. The integrated care program led to a robust improvement in outcome in patients for whom intervention was achieved relatively early, but had far less effect in patients with a DUP longer than 74 weeks.
Findings have profound implications for timely intervention
In an interview for PiM, the principal investigator for the RAISE project, Dr. John Kane, said that we can help patients deal with the fact that they have experienced the onset of a serious illness, and we help them achieve their goals and aspirations.
The more we succeed in improving outcomes, the more we will succeed in reducing the stigma of mental illness, he continued. But the longer the period of undiagnosed and untreated psychosis, the more difficult it is to achieve that good outcome.