Subject:
A New Treatment Program Effective for First-Episode Psychosis

Background:

Catching patients early in the course of their psychotic disorders may improve outcomes. A new NIMH-funded study compared a very comprehensive treatment program with treatment as usual, and the results were promising.

Methods:
The study is the first multisite, randomized controlled trial in the U.S. that compares outcomes of comprehensive, team-based coordinated care in early psychosis to usual care. Called RAISE-ETP (Recovery After an Initial Schizophrenia Episode—Early Treatment Program), the study tests an experimental treatment called NAVIGATE, which is assisted by a Web-based system called COMPASS. While the study contains many acronyms (perhaps too many), the term NAVIGATE itself is not an acronym—it’s just a good verb description of the goal of the program, which is to help patients “navigate” their way from that first episode of psychosis to recovery.
Researchers enrolled 404 patients with a first episode of psychosis and randomly assigned them to one of two treatment groups. Patients in the experimental arm (n=223) received the NAVIGATE package of treatments, which included personalized medication management, family psychoeducation, individual therapy focusing on resilience, case management, and employment and education support for at least 2 years. The control group (n=181) received treatment as usual, which in community mental health centers is mostly medication.

Actually, the study’s methods were a little more interesting than this. Instead of randomly assigning individual patients to these treatments, researchers randomly assigned clinics. Thus, of 34 community mental health centers enrolled, 17 were assigned to NAVIGATE and 17 were assigned to usual care. The advantage is that this confers a real-world flavor to the study. It’s more practical to train a clinic’s entire staff on how to provide a comprehensive suite of treatments than it is to pluck individual patients out of the clinic for specialized treatment at an academic center. The disadvantage is that it’s harder to make sure patients in the two groups are truly comparable because they weren’t randomly assigned individually. 

All the patients were between 15 and 40 years of age (mean was 23), with a history of only one episode of psychosis and a diagnosis of schizophrenia, schizoaffective, schizophreniform, or brief psychotic disorder (more than 50% had schizophrenia). Patients in the study had taken no more than 6 months of antipsychotic medications, and the average time between the onset of symptoms and first treatment was 74 weeks—nearly 1 and 1/2 years. The patients in the NAVIGATE group were more likely to be male than those in usual care (77% vs 66%), had worse PANNS scores (78 vs 74), were less likely to have had a prior hospitalization (76% vs 82%), and were less likely to be in school at baseline (16% vs 26%). Whether these group differences affected the results of the study is unclear. 

The NAVIGATE treatment technique:
So what were some of the specifics of the NAVIGATE treatment? While the paper didn’t get into details, the NAVIGATE website provides more information (www.navigateconsultants.org). Each patient is assigned 4 different clinicians: a prescriber, a therapist, a family education clinician, and a “supported employment and education” (SEE) specialist. There’s also an overall case manager who may be one of the existing team members. Patients have sessions with one or more team members weekly for the first 6–12 months, then less frequently (usually monthly) during months 12–18. 

There’s a detailed manual for each of the 4 treatments on the website available for free download. As a psychiatrist who doesn’t really specialize in psychosis, but who still sees plenty of psychotic patients, I found scanning these manuals to be quite helpful. I learned useful information on how to do cognitive restructuring with severely ill patients, on what supported employment actually means, and on how family education can be helpful. 

Results:
Patients were assessed every 6 months over 2 years. Those assigned to NAVIGATE had significantly greater improvement on the primary outcome measure—the Quality of Life Scale score. The largest improvements were seen in interpersonal relations, sense of purpose, motivation, curiosity, emotional engagement, and engagement in activities. A significantly larger proportion of NAVIGATE patients were either working or going to school during the study. In terms of core symptoms, NAVIGATE patients showed more improvement on psychotic and depressive symptoms in the Positive and Negative Syndrome Scale (PANSS). NAVIGATE patients stayed in treatment significantly longer than the usual treatment patients (median of 23 months vs 17 months). There was no significant difference in hospitalization rates between the two groups (relatively low rates in both groups of about 3%–4% per month or 34%–37% of patients hospitalized over two years). 

Finally, catching patients earlier helped their outcome. Patients who received NAVIGATE and who had a duration of illness less than 74 weeks had significantly greater improvement in quality of life and psychotic symptoms than those patients who went longer than 74 weeks before getting treated (effect sizes of 0.54 vs 0.07 for QLS and 0.42 vs 0.13 for PANSS—the larger the effect size, the greater the effect was of that intervention).

Carlat’s Take: 
A comprehensive care program for first episode psychosis patients appears to help more than treatment as usual, at least over a 2-year period. The authors say they are continuing their assessments for 5 years and will someday publish those results. A limitation of the study is that it’s not clear if the NAVIGATE program produced its benefits via its specific components or more non-specifically, by exposing patients to visits and more time with clinicians. A more systemic issue is whether community mental health centers can afford to implement NAVIGATE. That’s not clear, though the authors are optimistic, for two reasons: First, insurance covers many of the NAVIGATE services, such as medications, individual therapy, and family therapy; second, the federal government has allocated money to support programs targeting first-episode psychosis. Let’s hope that money helps.