The National Institute of Mental Health (NIMH) is launching a large-scale research project to explore whether using early and aggressive treatment, individually targeted and integrating a variety of different therapeutic approaches, will reduce the symptoms and prevent the gradual deterioration of functioning that is characteristic of chronic schizophrenia.
The Recovery After an Initial Schizophrenia Episode (RAISE) project is being funded by NIMH with additional support from the American Recovery and Reinvestment Act (ARRA). RAISE is a model example of how money from the Recovery Act can accelerate science related to public health problems and potentially benefit those citizens most in need.
“This new initiative will help us determine whether intervention that is started early, incorporates diverse treatment and rehabilitation approaches, and is sustained over time, can make it possible for more people with schizophrenia to return successfully to work and school,” said NIMH Director Thomas R. Insel, M.D. “Moreover, the interventions being tested will be designed from the outset to be readily adopted in real-world health care settings and quickly put into practice.”
Despite the availability of moderately effective treatments, such as antipsychotic medications and various psychosocial interventions, people with schizophrenia often do not receive treatment until the disease is already well-established, with recurrent episodes of psychosis, resulting in costly multiple hospitalizations and disabilities that can last for decades. Periods of unemployment, homelessness, and incarceration are common, making schizophrenia a costly disease for individuals, their families, and the community at large.
RAISE will test approaches that involve intervening immediately upon first diagnosis, systematically incorporating the range of options that are now available in a more piecemeal fashion to people with schizophrenia. These options include medications, psychosocial treatments, and rehabilitation, including teaching patients and families how to manage the disease. The hope is that such a coordinated approach tailored to each individual and sustained over time may make lasting differences in the acceptability of treatment and overall function.
Agencies and organizations that play a role in providing health care and other services to people with schizophrenia will have an opportunity to participate in the design of the interventions to be evaluated by RAISE. Federal organizations, including the Substance Abuse and Mental Health Services Administration, the Social Security Administration, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, the Walter Reed Army Medical Center, and the National Institute on Drug Abuse, will be involved along with mental health care consumers and family members, private health care providers, additional scientific experts, and state and local agencies. Other agencies may become involved as the project proceeds. Involving these stakeholders will help ensure that, if successful, this evidence-based approach can be disseminated and adopted rapidly, thus significantly speeding the transition between research findings and their use in real-world practice.
Two research groups will work in parallel to develop and test potential intervention approaches. One group will be led by John M. Kane, M.D., of the Zucker Hillside Hospital, Feinstein Institute for Medical Research, Manhasset, N.Y. The second group will be led by Jeffrey Lieberman, M.D., of the Research Foundation for Mental Hygiene, Inc., New York City. The research teams feature national and international collaborations, with treatment to be delivered in up to 30 clinical sites across the United States.
Recovery Act funds will underwrite the initial two phases of the trial, during which the investigators will refine the interventions with input from stakeholders and conduct a feasibility study to demonstrate that each intervention can be fielded in real world community treatment settings and be evaluated in a randomized clinical trial design. With long-term funds committed by NIMH to complete these phases plus a full-scale clinical trial, funding for the study is $40 million.
“Depending on the study’s outcome, RAISE could help set the stage for a paradigm shift in the way schizophrenia is treated in the United States. The ultimate goal of the initiative is to eliminate the chronic form of schizophrenia that is so costly and devastating to the individual, family members, and society as a whole,” said Robert Heinssen, Ph.D., acting director of the NIMH Division of Services and Intervention Research and project officer for RAISE. “This Recovery Act-supported project will hire and help train many mental health researchers and care providers for a project that is likely to help some of our most vulnerable citizens lead more productive and satisfying lives.”
NIMH is using Recovery Act funds to carry out objectives identified in its Strategic Plan. Among these objectives is to develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses and to strengthen the public health impact of NIMH-supported research.