Treatment manuals: use in the treatment of bulimia nervosa

As psychology has moved toward emphasizing evidence-based practice, use of treatment manuals has extended from research trials into clinical practice. Minimal research has directly evaluated use of manuals in clinical practice. This survey of international eating disorder professionals examined use of manuals with 259 clinicians’ most recent client with bulimia nervosa. Although evidence-based manuals for bulimia nervosa exist, only 35.9% of clinicians reported using a manual. Clinicians were more likely to use a manual if they were younger; were treating an adult client; were clinical psychologists; were involved in research related to eating disorders; and endorsed a cognitive-behavioral orientation. Clinicians were less likely to use a manual if they provided eclectic psychotherapy that incorporated multiple psychotherapeutic approaches. We conclude that psychotherapy provided in clinical practice often does not align with the specific form validated in research trials, and “eclecticism” is at odds with efforts to disseminate manuals into clinical practice.     

Dialectical Behavior Therapy Is Effective for the Treatment of Suicidal Behavior: A Meta-Analysis

Dialectical Behavior Therapy (DBT) prioritizes suicidal behavior and other self-directed violence as the primary treatment targets, and has been demonstrated to reduce self-directed violence in clinical trials. This paper synthesizes findings from controlled trials that assessed self-directed violence and suicidality, including suicide attempts, non-suicidal self-injury (NSSI), suicidal ideation, and accessing psychiatric crisis services. Eighteen controlled trials of DBT were identified. Random effects meta-analyses demonstrated that DBT reduced self-directed violence (d = -.324, 95% CI = -.471 to -.176), and reduced frequency of psychiatric crisis services (d = -.379, 95% CI = -.581 to -.176). There was not a significant pooled effect of DBT with regard to suicidal ideation (d = -.229, 95% CI = -.473 to .016). Our findings may reflect the prioritization of behavior over thoughts within DBT, and offer implications for clinical practice and future research concerning the implementation of DBT for acute suicidality.     

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.     

Conducting Outcomes Research in a Clinical Practice Setting: The Effectiveness and Acceptability of Acceptance and Commitment Therapy (ACT) in a Partial Hospital Program

Multiple challenges exist integrating research into clinical practice, particularly in acute care settings where randomized controlled trials may be impractical or unethical. Partial or day hospitals are one such setting. As compared to outpatients and inpatients, relatively little research is conducted or reported in partial hospital program (PHP) patients, leaving providers in this setting without a solid empirical basis from which to draw. We report treatment outcomes and patient satisfaction from the first 750 patients enrolled in a clinical research PHP utilizing the acceptance and commitment therapy (ACT) treatment model. ACT is a well-established, transdiagnostic behavior therapy. However, to date no study has examined the use of ACT in acute day hospitals. We hypothesized that applying ACT with this patient group would result in significantly improved depression, anxiety, functioning, and quality of life from intake to discharge. We additionally expected that patients would report high satisfaction with ACT treatment groups. Patients (n = 750 full sample, n = 518 completed treatment) completed daily measures of symptoms, functioning, and ACT processes at intake and discharge, and postgroup satisfaction surveys. Results showed significant improvements in symptoms and impairment. ACT process variables also increased over the course of treatment. Importantly, patient satisfaction was high for all groups. Thus, ACT provides an appropriate, flexible, effective, and satisfactory model for this patient group. A comparison of our findings using ACT to the limited research using other models in PHP settings is discussed, as well as challenges in the overall process of integrating research into routine clinical care.     

Are explanatory trials ethical? Shifting the burden of justification in clinical trial design

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.     

Autonomy support and preference-performance dissociation in choice-reaction time tasks

The purpose of the current study was threefold: (a) to examine the effects of participants having the autonomy to choose the practice order of two reaction time (RT) tasks – a choice-RT task and a Simon task – on performance, (b) to examine whether one order of practice is better than the other, and (c) to examine whether participants might choose a practice order that hinders their performance. The study was conducted online and participants completed the tasks on their own computer. Fifty-nine participants were randomly assigned into three groups: (a) autonomy – participants chose which task they would like to practice first, (b) choice-first – participants practiced the choice-RT task first, and (c) Simon-first – participants practiced the Simon task first. Out of these three groups we created an autonomy group (n = 17) and a no-autonomy (yoked) group (n = 17). All participants performed eight familiarization trials of each task, practiced 160 trials (8 blocks × 20 trials) of each task, and performed a post-test of 20 additional trials of each task after a three-minute rest. The main findings were that (a) participants in the autonomy group had faster RTs compared with participants in the no-autonomy group, (b) performing the choice-RT task first led to faster RTs compared with performing the Simon task first, and (c) nine of the 17 participants in the autonomy group chose to practice the Simon task first. The findings of this study suggest that providing participants with autonomy can lead to improved performance. However, there may be a dissociation between participants' preference of practice order and their performance.     

A Model for Adapting Evidence-Based Interventions to Be LGBQ-Affirmative: Putting Minority Stress Principles and Case Conceptualization Into Clinical Research and Practice

The mental health field now possesses clinical trials attesting to the efficacy of affirmative practice with sexual minority individuals. With the goal of efficiently moving the results of these clinical trials into real-world clinical practice, this paper offers a model for adapting existing evidence-based practices originally developed for the general population to be lesbian, gay, bisexual, and queer (LGBQ)-affirmative. The adaptation model presented here guides clinicians to incorporate six LGBQ-affirmative transtheoretical principles of change into practice. These principles facilitate raising awareness of the impact of minority stress on sexual minority clients’ mental health and on client self-evaluation while drawing upon sexual minority resilience and intersectional experiences to build empowering coping skills and validating relationships. The adaptation model also provides a transtheoretical approach to case conceptualization that directs clinicians to consider the role of early and ongoing minority stress on sexual minority clients’ cognitive, affective, motivational, behavioral, and self-evaluative experiences that maintain current distress. This case conceptualization approach highlights common associations among these experiences, suggesting clear routes of interventions for many sexual minority client presentations. Case examples from recent clinical trials of LGBQ-affirmative cognitive-behavioral therapy illustrate how these principles and this case conceptualization can be effectively utilized in practice. While the principles and case conceptualization are meant to be transtheoretical and therefore applicable across therapeutic techniques, to date they have been tested only in clinical trials for cognitive-behavioral treatments. Therefore, this paper concludes with a call for future research to determine the effectiveness of implementing this adaptation model across diverse therapeutic modalities and client presentations.     

Testing Clinical Intuitions About Barriers to Improvement in Cognitive-Behavioral Therapy for Panic Disorder

Although clinical intuitions influence psychotherapeutic practice and are a rich source of novel hypotheses for research, many remain to be empirically tested. This study evaluates whether clinicians’ beliefs about barriers to progress in cognitive-behavioral therapy (CBT) for panic disorder are supported by data. Data from a randomized-controlled trial comparing CBT to panic-focused psychodynamic psychotherapy (PFPP) for adults with primary panic disorder (N = 161) were used to evaluate 15 factors endorsed by clinicians as impediments to CBT in a recent survey. Panic severity was assessed before, during (at Weeks 1, 5, and 9), and at termination of treatment (Week 12) using the Panic Disorder Severity Scale. Hierarchical linear modeling revealed that none of the perceived barriers were predictive of poor outcome. Contrary to clinicians’ intuitions, dissociation during panic attacks was associated with greater symptomatic improvement in both treatment arms (β = ?0.69, p < .05), above the effect of established predictors. Moderation analyses revealed that when patients had PTSD diagnosed with the Anxiety Disorders Interview Schedule (β = 1.71, p < .05) or less severe panic disorder (β = 0.45, p = .04), they changed more rapidly in CBT than in PFPP. Overall, clinician agreement was inversely related to the strength of a predictor (r = ?.24, p = .39). Although clinical intuitions can be useful as clinical and empirical signals, such beliefs should be critically examined before informing practice. Dialogue between academics and clinicians might be enhanced through research that incorporates input from front-line practitioners.     

Building tasks from verbal instructions: An EEG study on practice trial exposure and task structure complexity during novel sequences of behavior

Configuring the mind to perform a novel task is an effortful process and one that is related to differences in general intelligence. Previous research has suggested that when participants are given instructions for a future task, representations of the rules contained in the instructions can influence subsequent behavior, even when the rules are not necessary to perform the upcoming task. One hypothesis for the continued activation of rule representations suggests that the practice trials participants perform before the experimental trials may instantiate the unnecessary task rules into participants’ mental model of the task (i.e., the task space). To test this hypothesis, EEGs were recorded as participants (N = 66) completed a multirule task designed to contrast the effects of increasing task structure complexity and practice trial exposure. The results showed that, as was predicted, performance is significantly poorer when more task rules are specified in the task instructions. Practice trials with the extra rule did not affect task performance, indicating that an unacted verbal instruction is sufficient to incorporate the rule into participants’ mental model of the task. The EEG results showed that instruction complexity was linked to a phasic increase in frontal theta synchronization but reduced posterior alpha and beta desynchronization. These changes in synchronization occurred during a time period of low intertrial phase coherence and suggest that participants were “checking the task rules” amidst a trial. This transient neural activity may reflect compensatory mechanisms for dealing with increased mind-wandering that is more likely to occur in complex tasks.     

The epistemology and ethics of chronic disease research: Further lessons from ECMO

Robert Truog describes the controversial randomized controlled trials (RCTs) of extracorporeal membrane oxygenation (ECMO) therapy in newborns. Because early results with ECMO indicated that it might be a great advance, saving many lives, Truog argues that ECMO should not have been tested using RCTs, but that a long-term, large-scale observational study of actual clinical practice should have been conducted instead. Central to Truog’s argument, however, is the idea that ECMO is an unusual case. Thus, it is an open question whether Truog’s conclusions can be extended to other areas of medical research. In this paper, I look at epistemological and ethical issues arising in the care of patients with chronic diseases, using ECMO as a starting point. Both the similarities and the dissimilarities of these two cases highlight important issues in biomedical research and support a conclusion similar to Truog’s. Observational studies of clinical practice provide the best evidence to inform the treatment of patients with chronic disease.     

Self-control over combined video feedback and modeling facilitates motor learning

Allowing learners to control the video presentation of knowledge of performance (KP) or an expert model during practice has been shown to facilitate motor learning (Aiken, Fairbrother, & Post, 2012; Wulf, Raupach, & Pfeiffer, 2005). Split-screen replay features now allow for the simultaneous presentation of these modes of instructional support. It is uncertain, however, if such a combination incorporated into a self-control protocol would yield similar benefits seen in earlier self-control studies. Therefore, the purpose of the present study was to examine the effects of self-controlled split-screen replay on the learning of a golf chip shot. Participants completed 60 practice trials, three administrations of the Intrinsic Motivation Inventory, and a questionnaire on day one. Retention and transfer tests and a final motivation inventory were completed on day two. Results revealed significantly higher form and accuracy scores for the self-control group during transfer. The self-control group also had significantly higher scores on the perceived competence subscale, reported requesting feedback mostly after perceived poor trials, and recalled a greater number of critical task features compared to the yoked group. The findings for the performance measures were consistent with previous self-control research.     

Commentary on Koons et al.’s (2013) “Negotiating for Improved Reimbursement for Dialectical Behavior Therapy: A Successful Project”

This paper provides a commentary of Koons, O’Rourke, Carter, and Erhardt (this issue), which takes an inspiring first step in bridging research and clinical practice. We encourage the field to take the following from this paper: (a) evidence-based treatment (EBT) can work in real-world settings; (b) publishable research can be accomplished in a purely clinical environment; (c) some insurance companies are willing to pay more for EBTs; and (d) getting sufficient pay for more time-consuming work has potential to help patients. Koons et al. found the crucial synthesis for all clinicians: In a purely clinical setting, research demonstrated that people got better and the providers were paid more for their work.     

Standards,Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

ABSTRACT

A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.     

Academic-industrial relationships: Opportunities and pitfalls

Over the past 50 years, academic-industrial collaborations and technology transfer have played an increasingly prominent role in the biomedical sciences. These relationships can speed the delivery of innovative drugs and medical technologies to clinical practice, creating important public health benefits as well as income for universities and their faculty. At the same time, they raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research. The leadership of Harvard Medical School convened a group of leaders in academic medicine to formulate guidelines on individual financial conflicts of interest. They and other groups are working to formulate a national consensus on this issue. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

A Systematic Review of Ethnoracial Participation in Randomized Clinical Trials of Behavioral Activation

As of the last available NIH report, people of color (POC) constituted 28.1% of enrollment across all U.S. domestic clinical trials. The literature on prevalence rates of depression among POC is mixed. While the prevalence rates of depression may vary across POC, it remains unknown to what degree POC have been included in outcome clinical trials of depression since NIH’s mandates for inclusion of minorities in clinical outcome research. Following PRISMA guidelines, the present review identified randomized controlled trials of behavioral activation from 1989 to 2021 using the following search engines: PsycINFO, EMBASE, and Cochrane Central Register of Controlled Trials. We reviewed 5,247 articles and included 28 articles that met full inclusion criteria (n = 5,169 participants). Across studies included in this review, 70% were non-Latinx White, 14.1% were African American, 8.9% were Latinx, 0.5% were Asian, 2.9% were other, and 3.7% were unknown. Results indicated an increase in representation of ethnoracial inclusion rates across time and that recruitment method was not associated with adequate inclusion of POC. However, the university setting was associated with inadequate representation of POC.     

Exploring automaticity in text processing: syntactic ambiguity as a test case

A prevalent assumption in text comprehension research is that many aspects of text processing are automatic, with automaticity typically defined in terms of properties (e.g., speed and effort). The present research advocates conceptualization of automaticity in terms of underlying mechanisms and evaluates two such accounts, a computational-efficiency account (underlying computational processes become more efficient with practice) and a memory-based processing account (the underlying basis of processing shifts with practice, from computing interpretations to retrieving prior interpretations). In five experiments, short texts containing either an ambiguous or unambiguous syntactic structure were presented for multiple study trials. In both conditions, reading times in target regions decreased across trials, indicating automatization. Several findings supported the memory-based processing account (e.g., practice effects were largely item-specific, reading times were longer for ambiguous versus unambiguous sentences on early trials but converged on later trials) Some evidence was also found for a contribution of gains in computational efficiency (i.e., some item-general practice effects were observed). Implications for research on automaticity and text processing are discussed.     

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.     

Felicitometric hermeneutics: interpreting quality of life measurements

The use of quality of life (QOL) outcomes in clinical trials is increasing as a number of practical, ethical, methodological, and regulatory reasons for their use have become apparent. It is important, then, that QOL measurements and differences between QOL scores be readily interpretable. We study interpretation in two contexts: when determining QOL and when basing decisions on QOL differences. We consider both clinical situations involving individual patients and research contexts, e.g., randomized clinical trials, involving groups of patients. We note the ethical importance of such understanding: proper interpretation and communication facilitate health care decision making. Communication that facilitates interpretation is of moral significance since better communication can attenuate ethical problems and inform choices. Much of what is communication worthy about QOL assessments is determined by the particular QOL instrument used in the assessment and how it is administered. In practice, these choices will be driven by the purpose of the assessment, but, it is argued, to maximize understanding, we should combine the information garnered from traditional standardized QOL instruments, from individualized QOL assessments, and from a recently proposed dialogic paradigm, where QOL is determined by shared conversation regarding the interpretation of texts. And, while some studies can surely succeed using abbreviated methods of administration (e.g., postal surveys may suffice for certain purposes), we will focus on methods of administration involving interviewer?Crespondent interaction. We suggest that during the QOL elicitation process, interviewer and respondent should engage in a two-way conversation in order to achieve a shared understanding of the ??answers?? to QOL ??questions?? and, finally, to reach a shared interpretation of the individual??s QOL.     

Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part

Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand the experiences and motivations of young people who took part in clinical trials. This is a qualitative interview study of 25 young people aged 10–23 who were invited to take part in clinical trials. Interviews were audio or video recorded and analyzed using framework analysis. Young peoples' motivations were both personal benefit and helping others. Both incentives appeared to be more complex than expected. We introduce the terms “network of exchange” and “intergenerational solidarity” to describe these motivations. To improve recruitment, professionals should be more open about research opportunities, provide better information, and give young people feedback after the trial has ended.     

Placebo effects in developmental disabilities: implications for research and practice

Recent clinical trials of secretin in children with autism showed robust placebo effects and no benefit of secretin over placebo. This article explores the reasons for the observed placebo effects, focusing on the heightening of positive expectancy by media attention and by the sensory experiences associated with intravenous injections. Comparisons are drawn with research involving other novel treatments and other clinical populations of children with developmental disabilities and neurobehavioral disorders. Research regarding mechanisms of placebo effects is reviewed, including patient and clinician attributes, expectancy effects, participation effects, changes in caregiver behavior, and conditioning. New evidence regarding the biological basis of placebo effects is briefly presented. Since placebo effects are ubiquitous and may operate by a variety of mechanisms, research design is critical in designing clinical trials and in evaluating other outcomes research. Measurement issues important for research in developmental disabilities are emphasized. Ethical concerns have been raised regarding the use of placebo in clinical research, but current analysis suggests that placebo controls are necessary and defensible on ethical grounds, if certain conditions are met. The study of placebo effects ("placebology") holds great promise as a new area of research in therapeutics. The author's research in the potential augmentation of stimulant effects in children with attention deficit/hyperactivity disorder (ADHD) by adding placebo in open label is briefly presented. The placebo has always been integral to the practice of medicine, but advances in scientific medicine and medical ethics have diminished the role and use of placebo in practice. An innovative approach to the ethical use of placebo is proposed.