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Study shows efficacy, feasibility of NIMH RAISE first-episode psychosis treatment program

A comprehensive first-episode psychosis treatment program is effective and implementation is feasible in U.S. community clinics, according to results from the NIMH Recovery After an Initial Schizophrenia Episode-Early Treatment Program study.

“Comprehensive first-episode psychosis programs that emphasize low-dose antipsychotic medications, cognitive-behavioral psychotherapy, family education and support, and vocational and educational recovery have been implemented worldwide, but few randomized controlled trials have compared multimodal, multidisciplinary team approaches to usual care in first-episode psychosis,” John M. Kane, MD, of Zucker Hillside Hospital, North Shore–Long Island Jewish Health System, Glen Oaks, New York, and colleagues wrote. “Such programs can be easier to implement in settings with a national health care system, which is perhaps why a multisite study of first-episode psychosis treatment has never been conducted in the United States in nonacademic, community clinics under existing reimbursement mechanisms.”

To test NAVIGATE — a comprehensive, multidisciplinary, team-based treatment approach for first-episode psychosis — in a real-world setting, researchers randomly assigned 34 clinics in 21 states to NAVIGATE or community care. Diagnosis, duration of untreated psychosis and clinical outcomes were assessed over 2 years among 404 individuals with schizophrenia and at least 6 months of antipsychotic treatment. The mean age of participants was 23 years. The primary outcome was total score of the Heinrichs-Carpenter Quality of Life Scale.

“NAVIGATE consisted of four evidence-based interventions: personalized medication management, family psychoeducation, resilience-focused individual therapy, and supported employment and education,” Thomas Insel, MD, director of the NIMH, said in an accompanying editorial. “The component interventions were offered as a package, with the addition of a team leader who coordinated services and served as a primary point of contact for individuals and their families.”

Researchers found greater improvements in quality of life (P < .02) and psychopathology and greater work and school involvement (P < .05) among the 223 recipients of NAVIGATE compared with the 181 recipients of community care.

Individuals who received NAVIGATE also stayed in treatment longer than those who received community care (P < .004).

The median duration of untreated psychosis was 74 weeks. Individuals who received NAVIGATE whose untreated psychosis lasted less than 74 weeks had greater improvements in quality of life and psychopathology compared with those with a longer duration of untreated psychosis and those in community care.

Hospitalization rates were relatively low compared with other first-episode psychosis clinical trials and did not differ between groups, according to researchers.

“The RAISE-ETP study demonstrates that diverse U.S. community clinics can implement a team-based model of first-episode psychosis care, producing greater improvement in clinical and functional outcomes as compared with standard care,” Kane and colleagues wrote. “These effects were more pronounced for those with shorter duration of untreated psychosis, suggesting that the receipt of appropriate first-episode psychosis treatment at the proper time in the illness course can have a substantial impact on outcomes.” – by Amanda Oldt

Disclosure: Kane reports consultant roles for Alkermes, Amgen, Bristol-Myers Squibb, Eli Lilly, EnVivo Pharmaceuticals (Forum), Forest, Genentech, H. Lundbeck, Intra-Cellular Therapies, Janssen Pharmaceutical, Johnson and Johnson, Merck, Novartis, Otsuka, PierreFabre, Reviva, Roche, Sunovion, and Teva; receiving honoraria for lectures from Bristol-Myers Squibb, Genentech, Janssen, Lundbeck, and Otsuka; and being a shareholder in MedAvante and Vanguard Research Group. Please see the full study for a list of all authors’ relevant financial disclosures.