A Tool to Advance the Effectiveness and Dissemination of Empirically Supported Psychotherapies and the NIMH Public Health Research Agenda

Carroll and Nuro's (this issue) stage model will likely hasten the availability of more educationally effective and clinically complete therapy manuals for both research and practice. The model is an important and concise tool for broadly disseminating knowledge about psychotherapy manual development that has accrued over the 20 years since manuals became required for federally funded therapy outcome research. The current paradigm shift to a public health research agenda, spearheaded by the National Institute of Mental Health (NIMH), is evident in the model's specifications for stage III manuals. The immense challenge for researchers to truly meet the scientific demands of stage III manuals (and the NIMH's research charge) is briefly discussed. An autobiographical case report is also presented to illustrate that manuals for empirically supported therapies are not, in all cases, as "unfriendly" to practice and practitioners as much contemporary literature suggests, and as the stage model is intended to remedy.     

Treatment Manuals for the Real World: Where Do We Build Them?

Carroll and Nuro (this issue) outline a model for development of psychotherapy manuals that parallels the recently articulated stage model of psychotherapy research. The authors outline excellent considerations for treatment manuals in early, middle, and late stages of development. As manual testing moves from pilot studies and efficacy tests in university settings to transportability studies in clinical settings, the complexity of the manuals increases. These considerations also raise the broader question, however, of whether the stages of psychotherapy research as commonly implemented are best suited for developing treatments appropriate for "real-world" clinical settings. I suggest that all stages of research are perhaps better conducted in clinical as opposed to university settings. A change in research infrastructure would be challenging at first but could ultimately accelerate development of psychotherapy technologies.     

One Size Cannot Fit All: A Stage Model for Psychotherapy Manual Development

There has been controversy surrounding the roles and value of psychotherapy manuals in clinical practice since their inception. It has been underrecognized that the appropriate roles and content of manuals should evolve with the stage of development of a given treatment. This article proposes a stage model in which manuals are seen as evolving with the level of development of the treatment, from the basic outlines necessary for preliminary evaluation of the treatment in early pilot studies (stage I), to highly defined guidelines that demark the internal and external boundaries of treatment for efficacy studies (stage II), and finally to elaborated systems appropriate for use with diverse clinical populations (stage III). We propose guidelines for the content of manuals at the various stages, as well as strategies for developing "clinician-friendly" manuals to facilitate broader use of empirically supported treatments.     

A national survey of practicing psychologists' attitudes toward psychotherapy treatment manuals

There has been considerable debate and little empirical data on the role of psychotherapy treatment manuals in clinical practice. Attitudes toward treatment manuals are a potentially important determinant of how likely practitioners are to use manual-based treatments in clinical practice. A total of 891 practicing psychologists nationwide were surveyed about their attitudes toward treatment manuals and their ideas about the content of manuals. Practitioners held widely varying attitudes toward treatment manuals, and ideas about what constitutes a manual were associated with attitudes in a predictable way. Recommendations are made for how to gather more useful information about practitioners' attitudes toward the many changes affecting current models of clinical practice.     

A Stage Model of Behavioral Therapies Research: Getting Started and Moving on From Stage I

The progressively rigorous methodological requirements of conducting clinical trials of behavioral treatments has placed a large burden on individual investigators, as treatment manuals, methods of evaluating treatment quality and fidelity, and persuasive evidence of the treatment's promise are now virtual requirements of receiving support for conducting a clinical trial of a new or adapted treatment. A Stage Model of Behavioral Therapies research, by articulating the progressive stages of development and evaluation for behavioral treatments, recognizes the scientific merit and need for support for treatment development and initial evaluation designated as stage I. This article describes the conduct of stage I research, including issues addressed in stage I research, major design decisions confronted by investigators, the close relationship of stage I to stage II research and proposes a time line for stage I research.     

Improving psychotherapeutic services via randomized clinical trials, treatment manuals, and component analysis designs

In order to advance the practice of psychotherapy and to discover how to improve on the benefits of psychotherapy, we propose that practitioners and researchers should rely more on the results of randomized clinical trials research. On the practice side, the routine use by practitioners of manuals for empirically supported treatments holds the promise of providing scientifically based clinical services to clients. On the research side, there is much to be gained in using component analysis designs to determine the effective elements of a treatment that has been established as empirically supported in randomized clinical trials. Once these elements are identified, the next version of the treatment manual then could highlight the crucial aspects of treatment to be included in clinical practice. thus further refining scientifically based psychotherapeutic services.     

Psychotherapy for depression: current and future directions in research, theory, practice and public policy

This article is based on a symposium held at the 1998 Annual Meeting of Society for Psychotherapy Research (Snow Bird, Utah). Recognized experts addressed current and future directions in psychotherapy for depression from the perspectives of process and outcome research, basic research, theoretical models, clinical practice and training, and public policy. The specific issues discussed at the symposium included the strengths and limitations of major forms of psychotherapy; the therapeutic factors common and unique to different approaches; the future viability of current theories of depression; the role of treatment manuals in clinical practice and training; the development of new interventions based on basic research; and the priorities that should guide federal funding.     

Implicit and Untested Assumptions About the Role of Psychotherapy Treatment Manuals in Evidence- Based Mental Health Practice

We consider Carroll and Nuro's (this issue) model of treatment manual development in the broader context of attempts to bring accountability and evidence- based practice to clinical services. The current Zeitgeist surrounding treatment manual dissemination is guided by several implicit and largely untested assumptions. We describe each assumption, consider how it guides current thinking about dissemination of empirically supported treatments, and briefly summarize relevant research. We conclude that treatment manual development and dissemination, while clearly a worthwhile pursuit, is only one way to merge science and practice.     

The evolution of psychotheroapy training: reflections on manual-based learning and future alternatives

Although psychotherapists-in-training may rely significantly on their clinical intuitions when first beginning to practice therapy, they quickly discover that much more is required to conduct effective treatment. Increasingly over the past two decades, training manuals have been used to impart explicit guidelines to beginning psychotherapists. In addition, manuals offer a means for helping more experienced therapists to learn new approaches, while also allowing careful research on the relative efficacy of different psychotherapies. In some instances, manuals have been designed specifically to address troublesome transference and countertransference issues (e.g., Time-Limited Dynamic Psychotherapy; Strupp & Binder, 1984). But even manualized treatments that target hostile interactions between therapist and patient are sometimes of limited use in teaching therapists to work with difficult patients, as illustrated by the Vanderbilt II Psychotherapy Research Project. Experimental research on the distinctions between implicit learning and explicit learning (e.g., Lee & Vakoch, 1996) helps explain the constraints of manualized treatments. By relying on explicit, clearly articulated guidelines, treatments conducted in accordance with manuals may interfere with tacit reasoning processes. As a consequence of the strong emphasis that manuals place on explicit rules for treatment, this type of training can hinder the development of complex clinical judgments. Future generations of novice psychotherapists may benefit from training experiences that are designed to promote an integration of implicit and explicit learning.     

Toward evidence-based interventions for diverse populations: The San Francisco General Hospital prevention and treatment manuals

Clinical trials have seldom included adequate samples of people of color. Therefore, practitioners serving ethnic minorities often do not have access to readily available evidence-based interventions. This article summarizes the development and empirical evaluation of prevention and treatment manuals designed for low-income ethnic minority populations at San Francisco General Hospital. The manuals were often designed by people of color familiar with the communities for which they were developed. Independent research teams in multi-site national and international clinical trials have evaluated many of these manuals with encouraging results.     

Current status of phase I clinical trials in Asia: an academic perspectives

Clinical trials increasingly occured in Asia during the past years as pharmaceutical industries embraced globalization in the clinical research fields. The trend is true with phase III clinical trials but not for early stage/phase I clinical trials in Asian countries is still under-represented. The conduct of phase I clinical trials is considered more sophisticated and difficult than the later stage clinical trials. There are continuing concerns from the pharmaceutical industries about the capacity of Asian countries in conducting this type of clinical trials. We highlighted several problems concerning the ethical and scientific issues, the implementation of ICH-GCP and local regulations, investigators and clinical trial subjects. The purpose of this paper is to give some perspectives addressing the problems in conducting phase I clinical trials. Improving collaboration and capacity building among the Asian countries is a solution that we proposed in order to increase the quality and quantity of phase I clinical trials in Asian countries.     

Is Psychotherapy More Than Manual Labor?

Stimulated by Wilson's (this issue) elegant efforts to reassure researchers and practitioners of the soundness of using treatment manuals for purposes of training and practice, I have elected to discuss some likely responses of expert but non-manual-initiated psychotherapists to the following invitations: (a) to collaborate with researchers in efforts to improve treatment manuals and (b) to adopt manuals in their own clinical practice. I review the recent history of problematic outcome research findings and the researchers' clear denigration of the therapists' valued clinical judgment. The likely differential responses of novice and expert psychotherapists are discussed, as is the condition that is most likely to reduce the researchers' and practitioners' continuing state of "assault and nattery."     

Manual-Based Treatment: An Essential Ingredient of Clinical Practice in the 21st Century

Wilson (this issue) raises several thought-provoking issues pertaining to the use of manual-based treatments (MBTs) in clinical practice. Based on my experiences as a researcher of manual-based treatments for social phobia and as a clinical psychologist in independent practice, I share my perspective on several of Wilson's points. Comorbid conditions do not appear to hinder the outcomes of MBTs for social phobia, and participants in controlled clinical trials do not appear very different from persons who refuse or are excluded from participation. Manuals can be written in a manner that retains a great deal of flexibility for the clinician, and these manuals may be productively employed in clinical settings. Proper implementation of MBTs requires experience with the disorder of interest and a strong background in theories of psychopathology and therapy technique.     

The problem of the placebo response in clinical trials for psychiatric disorders: culprits,possible remedies,and a novel study design approach

The placebo response is a major issue in clinical trials for psychiatric disorders. Possible contributing factors to this problem include diagnostic misclassification, issues concerning inclusion/exclusion criteria, outcome measures' lack of sensitivity to change, measurement errors, poor quality of data entry and verification, waxing and waning of the natural course of illness, regression toward the mean phenomenon, patient and clinician expectations about the trial, study design issues, non-specific therapeutic effects, and high attrition. Over the past few decades, researchers have attempted to reduce the placebo effect in a variety of ways. Unfortunately, approaches with very little or no benefit have included restricting enrollment to selected populations, rater training, requirement of same rater, and placebo lead-in phases. Some benefits, although often marginal, have been derived from standardizing diagnostic procedures, managing clinicians' overestimation of change, simplification of study visits and assessments, minimizing non-specific, therapeutic effects, extending trial duration, reducing number of sites, increasing the sensitivity of outcome measures, and reducing the number of treatment arms. Thus far, there has been no attempt to develop new study designs aimed at reducing the placebo effect. We are proposing a novel study design, called 'Sequential Parallel Comparison Design', suitable for double-blind, placebo-controlled trials in psychiatric disorders. This design is aimed at reducing both the overall placebo response rate and the sample size required for such trials. Its usefulness in clinical research needs to be tested empirically. If this study design were to be found to meet its stated goals, this could markedly facilitate the process of clinical development of new compounds for the treatment of psychiatric disorders.     

Antiretroviral therapy for initial human immunodeficiency virus/AIDS treatment: critical appraisal of the evidence from over 100 randomized trials and 400 systematic reviews and meta-analyses

There have been over 100 randomized clinical trials (RCTs) of diverse regimens of antiretroviral therapy for treatment-naïve human immunodeficiency virus-positive patients. A further 400 systematic reviews and meta-analyses are informed by these trials. There are, however, difficulties in using systematic reviews and meta-analyses of this clinical evidence to inform guidelines and clinical practice. Several issues can make the interpretation of comparative effectiveness challenging. In this article, we review the key challenges in interpreting multiple trials in this population. We specifically examine the network geometry of the clinical trial comparisons, the predominance of non-inferiority trial designs, issues related to potential class effects, heterogeneous documentation of adverse events, and a relative lack of RCTs that reflect specific current clinical guideline recommendations. We conclude with recommendations for future clinical trials and meta-analyses.     

Assessing the Role of Treatment Manuals: Have They Become Necessary but Nonsufficient Ingredients of Change?

We argue that the controversies and ambivalence surrounding treatment manuals are in part due to three somewhat inconsistent functions that these manuals serve, or may soon be serving: (1) to provide detailed guidelines to clinicians, (2) to operationalize developmental steps in psychotherapy research programs, and (3) to serve as a list of options that might soon be guiding, and potentially dictating, treatment reimbursements. We also argue that although the slow pace of scientific development is at odds with the immediate needs of clinicians, the inconsistency between the first and second functions of treatment manuals is not a problem per se—it simply reflects the intrinsic dilemma underlying the Boulder model. A key problem, however, is the possibility that our current state of empirical knowledge might be used in the near future as the main basis for prescribing psychotherapy (i.e., the inconsistency between the second and third functions of manuals). Treatment manuals are described as necessary but nonsufficient tools that may be best used as the "first line of attack" in narrowly defined treatment conditions. The creation of a new task force is suggested to delineate such treatment conditions, to generate possible guidelines for addressing clinical situations that have not yet been empirically investigated, and to recommend future research directions to improve psychotherapy effectiveness. Finally, clinicians and researchers are encouraged to use a treatment strategy that has been empirically supported to entice third-party payers to fund future psychotherapy research.     

The promise of and problems with evidence-based medicine for paediatric asthma management

The concept of 'evidence-based medicine' has now been in widespread use in clinical practice for over a decade. There are different types of clinical study, which may provide evidence on which to base clinical decisions, but some are much less robust than others. In making decisions about treatment, one of the highest levels of evidence in primary research is the randomized controlled trial. This study design has been used in clinical research for over 50 years. Systematic reviews of randomized controlled trial are scientific studies that review, critically appraise and, where appropriate, aggregate results from a number of different randomized controlled trials. They are increasingly being used throughout health care to provide guidance about treatment. Under the auspices of The Cochrane Collaboration, systematic reviews of randomized controlled trials are being conducted across the whole of health care. One of the most active areas for this work is within the field of asthma and clinicians are now able to access a large number of different systematic reviews on The Cochrane Library. If used appropriately, they can aid the clinician in making decisions about individual patients and provide a sound evidence base from which clinical guidelines can be developed.     

Therapist Reactions to Manual-Guided Therapies for the Treatment of Adolescent Marijuana Users

Treatment researchers are increasingly advocating the use of evidenced-based treatment manuals. Here we describe therapist reactions to the use of manual-guided therapies in a multisite, randomized field experiment that evaluated five outpatient treatment protocols for adolescents who abuse or are dependent on marijuana. Data are summarized from qualitative interviews with 16 therapists and 3 case managers who provided the treatments. All of those interviewed felt that the manuals provided a structure to their therapeutic work, and the majority felt they were able to address individual patient needs. Therapists' reactions did vary depending on the type of manual they used (e.g., session-based, principle-based, or procedure-based). Recommendations for the development and use of manual-guided therapies to improve adolescent substance abuse treatment are discussed.