'Real World' Approach to Early Psychosis Markedly Improves Outcomes

Pam Harrison

October 20, 2015

UPDATED October 21, 2015 // A novel program that takes a comprehensive, multidisciplinary approach to first-episode psychosis significantly improves functional and clinical outcomes in young patients and can be successfully implemented in community-based clinics, new research shows.

Investigators at the Albert Einstein School of Medicine in New York City found that patients who underwent the so-called NAVIGATE program experienced greater improvement in quality of life and psychopathology and were more involved in work and school than their counterparts who received standard community care.

"What stimulated the study was the feeling that we could be doing a better job at providing the right treatment at the right time for people who've developed a psychotic disorder such as schizophrenia," lead author John Kane, MD, adjunct clinical professor of psychiatry and behavioral sciences, Albert Einstein School of Medicine, told Medscape Medical News.

Dr John Kane

"And the study was an opportunity to combine different aspects of treatment that have been studied elsewhere and to make sure that we could implement this kind of comprehensive, specialty-care model in the United States across a range of different clinics in different geographic locations.

"The finding that NAVIGATE was especially important for patients who received treatment early in their illness underscores the need for interventions that are tailored to new patients to keep them from developing chronic illness."

The study was published online October 20 in the American Journal of Psychiatry.

Improved Outcomes

A total of 404 individuals aged 15 to 40 years were enrolled in the study. Of these participants, 223 were assigned to the NAVIGATE program, and 181 to the community care group.

The mean age in both groups was 23 years, and the median duration of untreated psychosis was 74 weeks for the entire sample.

The majority of patients in both groups met diagnostic criteria for schizophrenia spectrum ― 56% of the NAVIGATE group, and 51% of the community care patients.

Each participant received at least 2 years of treatment.

The NAVIGATE program includes four core interventions. These include personalized medication management, family psychoeducation, resilience-focused individual therapy, and supported employment and education.

"NAVIGATE improved outcomes for patients over 24 months, with effects seen in length of time in treatment, quality of life, participation in work and school, and symptoms," the investigators write.

On the primary outcome measure, which was the Quality of Life Scale total score, NAVIGATE participants experienced significantly greater improvement during the 2-year assessment period than those in community care, with an effect size of 0.31, which was clinically meaningful.

Numerically, for the NAVIGATOR group, the mean change from baseline to month 24 on the Quality of Life Scale total score was 15.79, compared with 9.89 for the community care group.

More improvement was also found on the subscales of interpersonal relations, intrapsychic foundations (that is, a sense of purpose, motivation, curiosity, and emotional engagement), as well as engagement with common objects and activities.

Greater improvements were also seen on Positive and Negative Syndrome Scale (PANSS) total score (P < .02), the PANSS depressive factor score (P < .05), and the Calgary Depression Scale for Schizophrenia (P < .04) between baseline and month 24 for NAVIGATE participants compared with their community care counterparts.

Patients assigned to the experimental intervention remained in treatment longer than community care patients, at a median of 23 months, compared with a median of 17 months (P < .04), and were more likely to have received mental health outpatient services each month, at a mean of 4.53 services, compared with a mean of 3.67 services for those assigned to community care.

NAVIGATE participants were also much more likely to endorse receipt of key services included in the experimental intervention than patients in community care (P < .0001).

A significantly greater proportion of NAVIGATE recipients were either working or going to school at any time during each month of the program compared with the community care group (P < .05).

Comprehensive, Recovery-Oriented Intervention

Dr Kane and colleagues note that the duration of untreated psychosis significantly moderated the treatment effect of the experimental program with regard to the total Quality of Life Scale and PANSS scores over time.

Specifically, there was a "substantial difference" in effect sizes from treatment when comparing patients whose untreated psychosis lasted 74 weeks or less and those whose untreated psychosis lasted longer than 74 weeks. Treatment effects were significantly greater on both scales for those with a shorter duration of untreated psychosis.

"We were not entirely surprised that we found duration of untreated psychosis to be an important factor in the treatment effect," said Dr Kane.

"But it underscores the need for greater attention to be paid in reducing the duration of untreated psychosis, and it reminds us that with almost every mental illness, individuals often go not just for months but for years without getting the proper diagnosis, so we have to do a much better job at early identification and treatment."


Rates of hospitalization were relatively low and did not differ between the two groups.

Dr Kane noted that there has been progress in terms of funding and guidance for reimbursement for first-episode services.

In fact, federal agencies have shown a lot of interest in taking advantage of the research that the National Institute of Mental Illness (NIMH) has funded.

"The idea is that we are building on things that have been demonstrated to be effective, and we wanted to make sure they were brought together in a comprehensive, specialty-care model," Dr Kane said.

"So the importance of this study was to demonstrate that this can be done in real-world community clinics across the US and to show that the program really can have an impact on patient outcome."

The NAVIGATE program was developed as part of the Early Treatment Program of Recovery After an Initial Schizophrenia Episode, an NIMH initiative.

The Case for More Rapid Treatment

In an accompanying editorial, NIMH Director Thomas Insel, MD, said that one of the more remarkable aspects of the study was the substantial degree to which treatment effect was moderated by the duration of untreated psychosis.

Dr Thomas Insel

Indeed, as Dr Insel points out, the overall effects of NAVIGATE were largely driven by the robust response in both quality-of-life measures and overall symptoms among those with a shorter duration of untreated psychosis.

"The median duration of untreated psychosis in the entire sample was 74 weeks — a clear indication of the need to identify young people with mental illness at much earlier stages and to get them into effective treatment more rapidly," Dr Insel writes.

"These results demonstrate the importance of early detection, early engagement, and integrated care following the onset of psychosis," he added.

Dr Kane has been a consultant for Alkermes, Amgen, Bristol-Myers Squibb, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest, Genentech, H. Lundbeck, Intra-Cellular Therapies, Janssen Pharmaceutica, Johnson & Johnson, Merck, Novartis, Otsuka, PierreFabre, Reviva, Roche, Sunovion, and Teva. He has also received honoraria for lectures from Bristol-Myers Squibb, Genentech, Janssen, Lundbeck, and Ontsuka, and he is a shareholder in MedAvante and the Vanguard Research Group. Dr Insel has disclosed no relevant financial relationships.

Am J Psychiatry. Published online October 20, 2015. Full text, Editorial

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