The National Institute of Mental Health is putting its research and clinical muscle into determining whether early intervention in schizophrenia can improve outcomes later in life.

The Recovery After an Initial Schizophrenia Episode (RAISE) program, a research project of the NIMH, will test “whether early, aggressive, and preemptive intervention can slow or halt clinical and functional deterioration in schizophrenia,” Amy Goldstein, Ph.D., said at the American Psychiatric Association’s Institute on Psychiatric Services.

Dr. Goldstein, who is associate director of the RAISE initiative, and her colleagues described the ambitious project, which includes a randomized clinical trial of community-based treatment, as well as a component for limiting disability from schizophrenia and promoting recovery through integrated care.

Instead of focusing on the management of established illness and entrenched disability in people with schizophrenia, RAISE is comparing the effectiveness of a phase-specific intervention for first-episode psychosis with usual community care. The RAISE investigators also are conducting an implementation study to determine which factors hinder and which facilitate quick adoption of early psychosis interventions.

With early treatment, patients tend to have better responses to antipsychotic medications and experience better outcomes with social and vocational rehabilitation programs. In addition, early intervention has “a greater impact for psychological therapies that target residual symptoms, behavioral adaptation, and quality of life,” said Dr. Goldstein, who also is chief of the NIMH Preventive Intervention Program.

RAISE ETP

The RAISE ETP (Early Treatment Programs) trial pits the RAISE “Navigate” model for community-based treatment of patients with first-episode psychosis with standard care. Navigate uses a team-based approach to provide patients with individualized psychopharmacology, individual resiliency training, family psychoeducation, and supported employment and/or education, said coinvestigator Dr. Delbert G. Robinson of Hofstra North Shore-Long Island Jewish School of Medicine in Hempstead, N.Y.

Dr. Delbert G. Robinson
The medication component is supported by an online tool that can be used on desktop, laptop, and tablet computers. The tool combines clinician ratings, clinical findings, and patient self-reports to help identify the optimum medication for each patient.

In the ongoing RAISE ETP clinical trial, patients are randomized for a minimum of 2 years to the Navigate program or to a currently available treatment program at a community center. The programs are judged by clinical raters masked to randomization who conduct live, two-way video interviews to assess diagnosis and outcomes.

Although it is still too early to analyze the data, it is encouraging that the community centers participating in the trial were able to recruit 404 patients, and the study thus far has demonstrated that community centers with no previous experience in treating first-episode psychosis can provide integrated treatment, Dr. Robinson said.

“This is an RCT [randomized controlled trial] where the primary outcome measure is not symptoms, it’s quality of life,” he said.

RAISE Connection

The RAISE Connection Program is a two-site demonstration study of an intervention designed to limit the disability of patients with early-stage psychotic disorders by helping with recovery, empowerment, skills training, and personalized support, said Dr. Lisa B. Dixon, of the University of Maryland, Baltimore.

“With first-episode [psychosis], you don’t have people who think they have an illness; in fact, in most cases, they’re quite certain they don’t. So part of what we’re doing is to try to help them set the stage and develop a set of attitudes and relationships to their illness that will be durable lifelong,” she said.

The Connection team includes a full-time master’s-level clinician as team leader; a 0.20-0.25 full-time equivalent psychiatrist; a full-time supportive employment and education specialist; and a half-time recovery coach who deals with issues of self-management, substance abuse, and family.

For the first 1-3 months, the team strives to develop trusting relationships with the patient and his family and to identify community support, minimize stigma, and maintain continuity of care. The care includes home visits, meetings with caregivers, escorting patients to treatment, if needed, and ensuring that they have adequate housing and financial resources.

Over months 4-21, the staff help patients with social skills, wellness, and communications by mediating conflicts and helping the patient and his family and friends with coping and relapse-prevention strategies.

In the final phase, usually months 22-24, patients are helped with the transition to long-term care and community support.

Dr. Dixon described the Connection program as a cross between Critical Time Intervention programs, Assertive Community Treatment interventions, employment agencies, and drop-in centers.

“This model best fits a region with sufficient population density to support a fully dedicated team. A very big challenge for the field is how to position this kind of a model within an overall treatment continuum,” she concluded.

Dr. Goldstein and Dr. Dixon reported that they had no relevant disclosures. Dr. Robinson has received grant support from the NIMH. Bristol-Myers Squibb and Janssen have supplied medication for the research.