Evaluating the therapeutic misconception

The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.     

Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. In each case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants.     

The clinical effectiveness of cognitive behaviour therapy: outcome for a large sample of adults treated in routine practice

There is increasing interest in questions about how far the demonstrated efficacy of psychological therapies in research trials can be translated into clinical effectiveness in routine practice. This paper summarises outcome data from several hundred patients treated with CBT in routine clinical practice in a National Health Service psychology service, and compares their outcomes with some of the published research. Although the data have flaws common in ordinary clinical practice (no untreated controls, missing data, uncontrolled pharmacotherapy, etc.), the analyses suggest that CBT in this context is an effective treatment, albeit with probably not quite such good results as it achieves in research trials. Using clinical significance statistics on standardised measures, about half of the sample reliably improved over a course of therapy, including about a third who recovered to normal range.     

Ethical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits

Previous research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood disorders. This article examines the ecological validity of ketamine trials, measures to protect patients, informed consent procedures, financial inducements to participants and conflict of interest of researchers, therapeutic misconception, concealment, and deception. Further recommendations are purposed to improve ethical standard of clinical research involving ketamine.     

论临床试验中的治疗性误解及对策

研究和临床治疗在根本目的、基本方法、风险的正当性,以及应遵循的伦理原则等多方面都存在着根本性的区别。在临床试验的理论与实践中,混淆治疗与研究两者的区别,就会造成治疗性误解,从而违背科研伦理的知情同意原则,损害受试者的利益。以研究和治疗的区分为出发点,对治疗性误解的原因、引起的主要伦理问题及对策加以讨论。     

Can Clinical Research Be Both Ethical and Scientific? A Commentary inspired by Rosser and Marquis

Problems with clinical research that create conflicts between doctors’ therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. 1 suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science — to enhance the effectiveness of each.     

Systemic family therapy can be manualized: research process and findings

Determining the efficacy of therapeutic interventions is becoming an increasing political and ethical necessity. Comparative therapeutic outcome trials are most powerful when there is a precise specification, or manualization, of the forms that therapies took. Manuals have begun to be developed for structural/behavioural family therapy and couple therapy. The development of these manuals is often reliant on experts' self-report, rather than a systematic analysis of the therapeutic process as it happens. This can limit their validity and applicability to standard clinical practice. In addition, no manuals exist which reflect less structured forms of family therapy aimed at incorporating systemic, postmodern and narrative frameworks. The feasibility of producing a workable manual that reflects the fluidity of such practices has been questioned.
A research project to systematically create and test such a manual is reported. Multiple data sources and research methods, primarily qualitative, were applied to generate a rich specification of the therapy. In reporting these results the contents of various aspects of the final manual are indicated. Procedures to ensure that the prescribed practice is consistent with a widely used approach to systemic family therapy are also described.
The manual will be an important tool for outcome research and therapeutic practice. The account of the research process should be helpful to researchers engaged in constructing a manual for other models of family therapy based on a rigorous analysis of actual practice. The manual itself is available for use by outcome researchers who wish to evaluate this widely used form of systemic family therapy.     

Benchmarking Community-Based Couple Therapy: Considering Measurement Reactivity

Couple therapy has been shown to be effective in randomized clinical trials; however, results from naturalistic couple therapy have been less consistent. This study utilized a benchmarking approach to compare the effectiveness of couple therapy in a community-based setting with findings from efficacy treatments, such as treatment within randomized clinical trials. The current study is the largest couple therapy sample published to date (N = 3,347 couples). Clients in couple therapy were asked to provide initial and weekly ratings of symptomology on the Outcome Questionnaire (OQ-45.2). We found that treatment effect sizes found at community clinics were smaller than efficacy studies (i.e., the benchmark). However, when taking into account measurement reactivity, the effect sizes were comparable. This is the first benchmarking study for community-based couple therapy, allowing for meaningful comparisons and understanding of outcomes in real-world couple therapy. Implications for the field are offered in terms of evaluating community-based psychotherapy studies with benchmarking for couple therapy. Results of this study provide clinicians and researchers a way to meaningfully compare couple therapy outcomes, accounting for differences in community-based practices and randomized clinical trials. This benchmark also underscores the impact of measurement sensitivity, an issue commonly overlooked in psychotherapy research and practice.     

The Duty to Rescue and the Limits of Confidentiality

Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk.     

Definitional and Research Issues in the Common Factors Approach to Psychotherapy Integration: Misconceptions, Clarifications, and Proposals

This paper focuses on two common misconceptions of common factors in therapy. The first misconception entails the confusion between common factors and therapeutic factors, and thus the inappropriate and misleading use of the term therapeutic common factors in various situations. The second misconception is the mixing of commonalities of different kinds and levels in proposed lists and studies of common factors. These areas are discussed and clarified, and recommendations designed to facilitate conceptual and methodological improvements relative to each misconception are offered. The selection of best levels and kinds of common factors to be studied are further explored (i.e., the study of client change events and antecedent therapist behaviors across different therapies), and specific proposals for their research are outlined.     

Using empirical data to inform the ethical evaluation of placebo controlled trials

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Kurz- und Langzeitbehandlung in der Verhaltenstherapie

In Germany, short and long-term psychotherapy are the two established forms for providing basic outpatient cognitive behavior therapy. The goal of the current study is to describe and discuss empirical evidence for these two structural forms; therefore, results from randomized controlled trials are presented and their implications related to the optimal number of therapy sessions are described. Furthermore, important results of naturalistic process outcome research are outlined. Additionally, the individual needs of patients for specific numbers of sessions are described based on data from the Association of Statutory Health Insurance Physicians. The results of randomized controlled trials generally showed strong empirical evidence for the efficacy of short-term cognitive behavior therapy of 7–20 sessions in patients with simple diagnoses; however, there is less empirical evidence in relation to the general efficacy and differential indications for long-term behavior therapy. These study results are supported by data from 200,000 patients receiving outpatient treatment in the German healthcare system. In two thirds of these patients, less than 25 sessions were sufficient to achieve subjectively adequate clinical improvement; however, approximately 10?% of the patients needed more than 60 therapy sessions. Empirical evidence concerning outcomes of long-term therapy with such a high number of sessions is scarce. Future research should address this research gap in order to identify empirically-based individual adaptation rules concerning the optimal number of treatment sessions in long-term therapy.     

Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations

Pragmatic trials testing the effectiveness of interventions under “real world” conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.

     

Behavioral equipoise: a way to resolve ethical stalemates in clinical research

Randomized trials depend on clinicians feeling that they are morally justified in allowing their patients to be randomized across treatment arms. Typically such justification rides on what has been called "clinical equipoise"--when there is disagreement of opinion among the community of experts about whether one treatment is better than another, then physicians can ethically enter their patients into a clinical trial, even if individual physicians are not at equipoise. Recent debates over prominent studies, however, illustrate that controversy can be easily created rather than dispelled by trials, with many clinicians choosing not to use the proven therapy until they receive more convincing evidence of its superiority. In such situations, we propose that a new standard of equipoise be used to guide decisions about the ethical justifications for research trials--a standard of behavioral equipoise. Under behavioral equipoise, a trial is potentially justifiable if it addresses behavioral resistance to prior scientific evidence.     

Guided Internet-Based CBT for Common Mental Disorders

The Internet has become a part of most people’s lives in many parts of the world. Since the late 1990s there has been an intensive research activity in which psychological treatments, such as cognitive behavior therapy (CBT), have been found to be effective when delivered via the Internet. Most research studies indicate that the effects are larger when some form of guidance is provided from a therapist, and unguided treatments tend to lead to more dropout and smaller effects. Guided Internet treatments often consists of book length text materials, but can also include other components such as audio files and video clips. Homework assignment is often included and feedback is given for completed homework. Guided Internet-based CBT (iCBT) has been found to work for problems such as depression, panic-, social anxiety-, and generalized anxiety disorders. There are many research trials in which participants have been recruited via media, and there has been less research conducted in representative clinical settings. Most research has been conducted on adults and in university settings with nationwide recruitment. There is a need for treatments and studies on older adults, children and adolescents. In conclusion, dissemination of the research findings on guided iCBT to regular clinical settings is warranted.     

When "minimal risk" research yields clinically-significant data, maybe the risks aren't so minimal

Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the tasks mimic clinical care and are often conducted in clinical settings. Investigators should anticipate which measures could yield clinically-important findings and should describe explicit plans for data monitoring, disclosure, and follow-up. Protocols that include reliable and valid clinical measures should prompt a more detailed risk assessment by the IRB, even when the tasks meet the regulatory criteria for minimal physical, psychological, or emotional risk.     

Do criminal offenders specialize in crime types?

A common misconception exists that criminal offenders specialize in types of crime, such as serial murders, domestic violence, and sex offenses. This article explores the research on specialization in general criminal offenders, domestic violence offenders, and sex offenders. This review finds that although there are a few specialists, the majority of criminal offenders are generalists who exhibit wide versatility in offending. The implications for legal and mental health policies are discussed.     

Motivational Interviewing as an Adjunct to Cognitive Behavior Therapy for Anxiety Disorders: A Critical Review of the Literature

Cognitive behavior therapy (CBT) is efficaciously and effectively used in the treatment of anxiety disorders; however, as CBT for anxiety routinely utilizes exposure components, clients often experience ambivalence about treatment and their clinicians often must deal with resistance. Motivational Interviewing (MI) is a therapeutic strategy that addresses ambivalence about change in clinical interventions. MI has been applied as an adjunct for treatments such as CBT in order to increase motivation for and commitment to the intervention, especially when components of the treatment may be challenging (e.g., exposure, cognitive restructuring). Though researchers have commented specifically on the use of MI as a supplement to CBT for anxiety disorders, no comprehensive review has systematically assessed the strengths and limitations of extant literature on the topic, nor across anxiety disorders. Findings are summarized from 6 case studies and uncontrolled trials and 11 randomized controlled trials published through March 2016. An integrated critique of this literature also is offered. Limitations and the preliminary nature of the work in this area notwithstanding, it appears that it is feasible to supplement or integrate CBT with MI and that doing so has the potential to improve treatment initiation and engagement, as well as clinical outcomes. A number of directions for future research are addressed, such as determining which MI approaches to implement, with whom, when, and in what contexts.     

Do criminal offenders specialize in crime types?

A common misconception exists that criminal offenders specialize in types of crime, such as serial murders, domestic violence, and sex offenses. This article explores the research on specialization in general criminal offenders, domestic violence offenders, and sex offenders. This review finds that although there are a few specialists, the majority of criminal offenders are generalists who exhibit wide versatility in offending. The implications for legal and mental health policies are discussed.     

Re-evaluating the therapeutic misconception: response to Miller and Joffe

Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research.