NIMH Strategies for Moving Evidence-Based Mental Illness Treatments from Laboratory to Real World Therapies
The National Institute of Mental Health is funding small interdisciplinary networks to explore develop-ment of research plans that would move the growing body of knowledge about evidence-based treatments for mental illnesses out of psychology laboratories and into “real world” settings.
One group assembled by APS Member Marc Atkins, a child psychology specialist at the University of Illinois-Chicago, is examining the mental health capacity of schools and how the education system might improve that capacity.
“It includes clinicians, school people and researchers who meet regularly and plan to develop the research,” explained Grayson Norquist, Director of Services and Intervention Research at NIMH. “The ultimate goal is to have such groups aim toward a research program.”
NIMH is also weighing whether to fund large-scale Translational Research Centers in Behavioral Science (TRCBS) to advance the translation of basic behavioral science research and relevant integrative neuroscience research to address all aspects of mental disorders. The centers would be supported with up to $1.5 million a year for five years.
“An important goal of the centers,” states a program announcement on the TRCBS, “is to transcend the barriers of disciplines, research settings, and institutions in order to harness the full range of modern behavioral science to the service of the nation’s critical mental health needs…
“Since … [the centers] are defined by their integrative nature and not by departmental or geographic boundaries, projects constituting a given center may be based at a variety of institutions, representing both basic and clinical or services research.”
The centers are expected to include components from both basic behavioral science and clinical or services research settings and “must demonstrate the integration of basic and clinical work, with an organization conceived to promote sharing of information in both directions between the basic and clinical or services components.”
The TRCBS program and the small interdisciplinary networks are among the latest initiatives responding to a challenge posed a half dozen years ago by then director of NIMH Steven Hyman, when he convened the Clinical Treatment and Services Research Workgroup. In a preface to the group’s report, he charged it with the “urgent task” of developing tools to bridge the gap from research to practice and “better enable people with mental illnesses to receive optimal care.” (See excerpts from the group’s final report.)
“Through research,” Hyman wrote, “we continue to develop and refine an array of safe and efficacious interventions, yet more emphasis must be devoted to translating the yield of basic and clinical research into effective treatments for patients encountered in non-research settings. More attention must be paid, also, to designing treatment delivery systems and policies that facilitate provision of optimal care.”
NIMH has launched an array of strategies to accomplish the agenda the 1997 work group and its successors identified.
“We want research to move from basic science settings to real world settings,” said NIMH Deputy Director Richard Nakamura, an APS Fellow and Charter Member. “Part of that is to move beyond research to the places where the services are provided. We frequently find that treatments that work well in academic centers don’t work so well when you actually have people who have co-morbid conditions sitting in front of you in a clinic.
“Very often, when people leave their training in university [and begin clinical work], they wonder what world researchers are living in, compared to the world they see in the clinic. I think this program of ours is intended to solve some of those problems,” Nakamura said. “We want to make sure that evidence-based practices coming out of the labs here are useful in real-world settings, and to get feedback from [those settings] to get interventions that are more useful and practical.”
“Often, for clinicians, the kind of research that’s been done before is not necessarily relevant to the patient that is sitting in front of you,” said Norquist. The kinds of projects NIMH is now engaged in, he said, address basic underlying questions – infrastructure-building and requiring researchers to work with the various communities of service users, from clinicians, health maintenance organizations, and pediatricians to schools and even prisons.
“Just telling people what is the right thing to do does not get them to do it,” Norquist said. “In many cases, clinicians feel frustration because there are no empirically valid treatments available. We may not have any help for them, so they treat these disorders with whatever they can come up with themselves in the absence of validated treatments.”
Despite the lack of an evidence base, clinicians often believe they know what the intervention should be in a given case, he says, but there’s danger in generalizing from one or a few patients to the larger population. Nevertheless, “a lot of clinical discoveries have come from the bedside. Clinicians do recognize things. That’s one of our interests, to get more clinician-scientists into our research. Seeing a lot of people can be important in coming up with ideas about interventions.”
THE TRANSLATIONAL CONTINUUM
NIMH describes translational research as a continuum that extends from basic research into mental processes to pre-clinical research, from pre-clinical to clinical, and from testing interventions under controlled conditions to application of those interventions in real-world health care settings.
“We start with very basic models of behavior both at the human and animal level,” explained APS member Bruce N. Cuthbert, Chief of NIMH’s Adult Psychopathology and Prevention Research Branch. “For example, one of our projects takes research done by Steve Luck at the University of Iowa – basic research on brain mechanisms of attention – and collaborates with [University of Maryland psychologist] James Gold, who studies schizophrenia.
“The idea is to apply Luck’s models to schizophrenia patients to see how this works in schizophrenia. It appears that attention mechanisms of perception are relatively normal among schizophrenia patients; however, mechanisms that control retaining it in short term memory appear to be deficient in schizophrenia patients. The goal is not yet to uncover a treatment, but to understand the disorder better and apply that to a patient population. Then, we can use that to try to devise an improved treatment – behavioral or pharmacological.”
All along the translational continuum “we are starting to work with providers to get them involved at the research level,” said Norquist. “We’re asking how can we change consumers’, providers’, and even system-level behaviors, and to have feedback to understand what’s important to them, the kinds of interventions they need so researchers can start to tailor interventions to what they really need.”
If evidence-based interventions are to find their way into general practice, however, researchers also need to investigate what factors impede or enhance that process. This is why the Institute convened a “dissemination and implementation” work group in January 2002. Specifically directed to examine the dissemination and implementation of Children’s Mental Health Services, its findings could apply equally across NIMH’s other areas of concern.
“Efforts to disseminate knowledge to stakeholder groups or implement ‘evidence-based’ interventions have often failed partly due to their poor fit with the target audience or setting context,” the work group reported. “Current conceptual models, methods and strategies have also been largely ineffective at facilitating dissemination or implementation efforts to translate research into practice.”
‘INNATE DIFFERENCES’ AND OTHER HURDLES
Among the barriers the work group identified were hurdles that “likely stem from innate differences between ‘science’ and ‘practice.’… For instance, while scientific research seeks to first advance knowledge, clinical practice seeks to do what is immediately best for individual patients.
“While science progresses at a slow and incremental pace, the practice world requires quick decisions, sometimes in the face of no evidence. It is likely the case that as science increases its relation to local realities … it will also increase its chances for consumption.”
A second hurdle, the group reported, was understanding the target audience. “In the mental health community, this target audience varies widely from policy makers and state administrations to local providers or family consumers.”
Understanding organizational incentives and structures is also critical, the group said, because however willing an individual provider might be to incorporate new evidence-based practices, those efforts could be stymied by administrative obstacles, competition for resources, and readiness for change.
“[D]issemination and implementation research methodologies must take into account a flexible and complex process,” the group stated. “Current methodological designs often fail to capture contextual and process factors – critical to the analysis of dissemination and implementation.”
The participants noted, however, that research journals emphasize study outcomes at the expense of process factors. As a result, “Measurement tools to capture culture, context and process strategies are lacking, but likely exist in other fields of study.” This, they said, underscores the need for mental health dissemination and implementation research to use interdisciplinary approaches.
One fundamental need is to put infrastructure in place that can enable and support those interdisciplinary approaches along the continuum from basic research to service settings. NIMH’s primary tool for building the bench-to-practice infrastructure is the Interventions and Practice Research Infrastructure Program (IP-RISP), launched in response to recommendations of the 1997 Clinical Treatment and Services Research Workgroup.
“Little is known about how to best incorporate interventions into diverse settings or about what mental health care is in the day-to-day practices of different providers,” the IP-RISP public announcement stated. To fill that knowledge gap, the program seeks to partner academic settings with nonacademic clinical and service settings – ranging from health and community clinics to prisons and jails – that have large and diverse patient and provider populations but lack the resources for strong scientific research.
The announcement described such partnerships as win-win propositions: “The nonacademic settings can benefit … by providing empirical validation for treatment approaches and variations in care, creating robust evaluations of programmatic benefit and outcome, and assessing ways to improve care. The academic settings can benefit … by strengthening and diversifying their study populations and perspectives.”
Dissemination research is needed on two fronts: how best to deliver evidence-based interventions, and how to vary those interventions in practice to meet individual differences.
“The primary research challenge for the delivery of interventions in actual practice is to determine whether and how efficacious interventions can have a clear and beneficial effect when carried out in such settings with diverse and representative populations,” the IP-RISP announcement stated. “Similarly, the primary research challenge for practice research is to carefully characterize variations in care for individuals in typical practice settings, track pathways into care, delineate real practice factors associated with those variations, and use that knowledge to direct quality improvement and dissemination.”
NIMH launched its Dissemination and Implementation Research Program to address this variability by funding state-level efforts to build bridges between science and service.
“For many years, mental health researchers have assumed that an intervention deemed efficacious within clinical trials will be easily transmitted to the field; unfortunately, this has not been the case,” the program’s web site laments. “Recent literature has instead underscored the importance of understanding the many factors that affect whether the practice community will use a given intervention.
“Invited research on dissemination will address how information about mental health care interventions is created, packaged, transmitted, and interpreted among a variety of important stakeholder groups. Research on implementation will address the level to which mental health interventions can fit within real-world mental health service systems.”
One Request for Applications offers to fund states’ efforts to plan how to build a two-way bridge between science and service, focusing on the implementation of evidence-based practices, and a Program Announcement encourages mental health researchers to work with interdisciplinary scientists and practice stakeholders “to develop conceptualizations of dissemination and implementation that are applicable across diverse practice settings, and design studies that will accurately assess the outcomes of dissemination and implementation efforts.”
When it comes to actually disseminating evidence-based interventions, “we can do dissemination research,” Cuthbert said, “but talking to individual clinicians goes beyond our mandate.” For that part of the continuum, NIMH works with the Substance Abuse and Mental Health Services Administration (SAMHSA) to place evidence-based interventions within clinics and other service settings.
“Recently, we and SAMHSA initiated a program called ‘Bridging Science to Service’ to provide an initial list of evidence-based treatments for SAMHSA to consider – empirically supported and validated treatments proven to be scientifically effective, that can be distributed to all of SAMHSA’s grantees and health care sites to implement in the real world,” Cuthbert said. “We see this as a really exciting new program that provides an avenue for us to get some of these treatments out into the real world. We see this as an ongoing effort to maintain this avenue of dissemination for treatment.”
49-step Translational Action Plan
The NIMH Clinical Treatment and Services Research Workgroup, which includes the nation’s most distinguished treatment and services researchers, was convened in 1997 by Steven Hyman, then director of the National Institute of Mental Health, and staffed by APS Fellow and Charter Member Jane Steinberg, director of extramural activities at NIMH. Over the course of a year it met (including a meeting at the APS Convention) to review issues pertinent to translating science into practice. The following excerpt is from its final report, issued in 1998.
“Researchers, policy makers, health care providers, and most critically, individuals with mental illnesses and their families today recognize that translating the remarkable breakthroughs (of science) into procedures and policies of everyday clinical practice is an urgent, essential, and achievable task. …
“The Workgroup reviewed the NIMH research portfolio that extends from academic research settings to large, statewide service systems, to the moving target of ‘frontline’ clinical care. The review made vividly clear the need for mutually enriching interaction between research and both practice and service systems. …
“Toward this end, the Workgroup shaped an action plan with 49 recommendations for fulfilling the nation’s commitment to individuals with mental illnesses.”
The recommendations are grouped into four themes:
“Increase the usefulness of NIMH research for individuals with mental illnesses, clinicians, purchasers, and policy makers through informed priority-setting.
“Selectively expand the NIMH portfolio in the domains of efficacy, effectiveness, practice, and service systems research, to foster integration across these fields and to expedite the implementation of research-based practices and policies.
“Identify research innovations in design, methods, and measurement, to facilitate the translation of new information from bench to trial to practice.
“Strengthen NIMH’s leadership and administrative activities to provide the infrastructure to achieve the goals … in a timely manner.”
Examples under the fourth heading:
NIMH is asked to work with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) to encourage timely joint funding decisions for co-morbid substance abuse and mental illness research.
NIMH should explore shared review opportunities with NIAAA and NIDA to enhance the review of applications on co-morbid substance abuse and mental illness applications.
Review panels should have patients/consumers, providers, or policy makers as members to ensure expertise on the utility of research findings in intervention research.
The full report is available at: www.nimh.nih.gov/research/bridge.htm.
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