Developing and Implementing Randomized Effectiveness Trials in General Medical Settings.

Abstract

This article discusses the development of two mental health services research programs: one targeting depression treatment in primary care and the other early intervention for posttraumatic stress disorders in acute care. Both programs have used the randomized effectiveness trial to assess the delivery of empirically supported psychotherapeutic and psychopharmacologic interventions in these general medical settings. This article explores the fellowship training, clinical experiences, and conceptual frameworks that have informed the progression of the two research programs. Specific modifications to the traditional randomized clinical trial design employed in the effectiveness trials are discussed. This article concludes with reflection on intervention development trajectories and interdisciplinary team compositions that may facilitate the development of mental health interventions that both derive from the best scientific evidence and can be feasibly delivered in real-world treatment settings.

An epidemiologic approach to the development of early trauma focused intervention

“…Clinical psychologists have raised questions about the extension of data derived from experimental designs to social settings (Campbell, 1957) and regarding the ecological validity of experimental findings (Bronfenbrenner, 1977(Bronfenbrenner, , 1979. Public health approaches to the development of early, trauma-focused interventions would suggest that to develop ecologically valid interventions, external validity/generalizability assessments should be more fastidiously incorporated upfront into the design and implementation of clinical investigations (Glasgow & Emmons, 2007;Zatzick, Simon, et al, 2006).…”

“…Barriers in the widespread dissemination of evidencebased practice to real-world treatment settings may arise from aspects of the intervention development processes that fail to adequately take the influence of contextual factors on treatment implementation into consideration (Glasgow & Emmons, 2007;Zatzick, Simon, et al, 2006). A central difficulty may be the lack of focus on issues of external validity up-front in the research design.…”

“…To date, this bench-to-bedside conceptualization of treatment development may be seen as the predominant framework informing early trauma-focused interventions (Davis, Barad, Otto, & Southwick, 2006;Foa & Meadows, 1997;Litz, Gray, Bryant, & Adler, 2002;National Institute of Mental Health, 2002). Other commentary has suggested that diverse investigative designs that vary across efficacy, effectiveness, and dissemination/practice research paradigms may optimally inform the development of interventions that are feasibly and effectively delivered in real-world settings (Kazdin, 2001;National Institute of Mental Health, 1999;SouthamGerow, Ringeisen, & Sherrill, 2006;Street, Niederehe, & Lebowitz, 2000;Weisz et al, 2004;Zatzick, Simon, & Wagner, 2006). There exists, however, a paucity of discussion in the peer-reviewed literature of how diverse methodological approaches can inform the development of early, trauma-focused intervention.…”

Multilevel Interventions: Study Design and Analysis Issues

“…For example, if either of two interventions alone is sufficient to elicit the desired outcome, their combined effect might be less than the sum of their separate effects. Another motivation for a multilevel approach is the belief that interventions are more likely to transfer successfully to other settings if study designs help us understand contextual factors that affect implementation (25)(26)(27).…”

Collaborative Care Interventions in General Trauma Patients

“…Also, many patients leave the emergency department or inpatient ward without an established or referred primary care provider, compounding the disconnect between physical and mental health care. 49,59 The Institute of Medicine (IOM) has developed quality-o-care criteria designed to assist in assessment and intervention of trauma patients. All patient after-care should be based on evidence-based practices.…”