The Meaning vs. The Medical Model in the Empirically Supported Treatment Program: A Consideration of The Empirical Evidence

A review of the debate on the Empirically Supported Treatment Program is presented. It is argued that underlying the specifics of the debate are fundamentally incompatible paradigms: a meaning vs. a medical model. The findings from two gold standard multi-site studies are reviewed to conclude that the control condition meets requirements for an empirically supported treatment. The empirical finding of the failure of clinical training to improve treatment outcomes is explained by the focus on rational factors in training. It is recommended that training of therapists focus on enhancing experiential capacity rather than mastery of manualized treatment approaches.     

Informed consent and the use of placebo in poland: Ethical and legal aspects

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. 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.     

The Ethics of Type 1 Diabetes Prediction and Prevention Research

There are approximately one million cases oftype 1 diabetes in the US, and the incidenceis increasing worldwide. Given that two-thirdsof cases present in childhood, it is criticalthat prediction and prevention research involvechildren. In this article, I examine whethercurrent research methodologies conform to theethical guidelines enumerated by the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research, andadopted into the federal regulations thatprotect research subjects. I then offer twopolicy recommendations to help researchersdesign studies that conform to these ethicalrequirements.     

Treating PTSD in refugees and asylum seekers within the general health care system. A randomized controlled multicenter study

Objective

There has been uncertainty about whether refugees and asylum seekers with PTSD can be treated effectively in standard psychiatric settings in industrialized countries. In this study, Narrative Exposure Therapy (NET) was compared to Treatment As Usual (TAU) in 11 general psychiatric health care units in Norway. The focus was on changes in symptom severity and in the diagnostic status for PTSD and depression.

Method

Refugees and asylum seekers fulfilling the DSM-IV criteria for PTSD (N = 81) were randomized with an a-priori probability of 2:1 to either NET (N = 51) or TAU (N = 30). The patients were assessed with Clinician Administered PTSD Scale, Hamilton rating scale for depression and the MINI Neuropsychiatric Interview before treatment, and again at one and six months after the completion.

Results

Both NET and TAU gave clinically relevant symptom reduction both in PTSD and in depression. NET gave significantly more symptom reduction compared to TAU as well as significantly more reduction in participants with PTSD diagnoses. No difference in treatment efficacy was found between refugees and asylum seekers.

Conclusions

The study indicated that refugees and asylum seekers can be treated successfully for PTSD and depression in the general psychiatric health care system; NET appeared to be a promising treatment for both groups.

ClinicalTrials.gov registry number

NCT00218959.     

Cognitive-behavioral therapy for ADHD in medication-treated adults with continued symptoms

The purpose of the present study was to examine the potential efficacy, patient acceptability, and feasibility of a novel, cognitive-behavioral therapy (CBT) for adults with attention-deficit hyperactivity disorder (ADHD) who have been stabilized on medications but still show clinically significant symptoms. Thirty-one adults with ADHD and stable psychopharmacology for ADHD were randomized to CBT plus continued psychopharmacology or continued psychopharmacology alone. Assessments included ADHD severity and associated anxiety and depression rated by an independent evaluator (IE) and by self-report. At the outcome assessment, those who were randomized to CBT had lower IE-rated ADHD symptoms (p < .01) and global severity (p < .002), as well as self-reported ADHD symptoms (p < .0001) than those randomized to continued psychopharmacology alone. Those in the CBT group also had lower IE-rated and self-report anxiety (p's < .04), lower IE-rated depression (p < .01), and a trend to have lower self-reported depression (p = .06). CBT continued to show superiority over continued psychopharmacology alone when statistically controlling levels of depression in analyses of core ADHD symptoms. There were significantly more treatment responders among patients who received CBT (56%) compared to those who did not (13%) (p < .02). These data support the hypothesis that CBT for adults with ADHD with residual symptoms is a feasible, acceptable, and potentially efficacious next-step treatment approach, worthy of further testing.     

A call to restructure the drug development process: Government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care. The author is Adjunct Professor of Medicine, Weill Medical College of Cornell University, New York, New York, USA.     

The protection of patients’ rights in clinical trials

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. The author is Chairman, Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists.     

Can Psychoanalysis Become Empirically Supported?

The article discusses the application of the ideas of evidence-based medicine or empirically supported treatment to the field of psychoanalysis. The author argues that empirical support is gradual rather than categorical, and that the randomized clinical trial (RCT), which is commonly heralded as the appropriate method of support, confounds patient suitability factors with treatment 'as such'. As a consequence of the exclusive reliance on the RCT, empirical validation of psychological treatments has generally favoured cognitive-behavioural treatments, although there is ample evidence - albeit non-RCT - for the beneficial effects of short-term and long-term psychoanalytic treatment. The author argues for a suitability matching approach to empirical validation, where each treatment is tested, as powerfully as feasible, on samples based on selfselection (patient's choice, clinical assignment, suitability judgments etc.). The paper concludes by referring to two recent studies, indicating that there is reason to evaluate alleged empirical support with caution.     

Competing interests: The need to control conflict of interests in biomedical research

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. This paper is adapted from a lecture presented to a Symposium on Scientific Integrity, Warsaw, Poland, 23 November 1995. Daniel Steiner was Vice-President and General Counsel of Harvard University (1972–92) and in that capacity became familiar with conflict of interest issues. He is currently Counsel to the Boston law firm. Ropes and Gray, and is Adjunct Lecturer in Public Policy at the John F. Kennedy School of Government. Harvard University.     

Cognitive-behaviour therapy for chronic fatigue syndrome: comparison of outcomes within and outside the confines of a randomised controlled trial

Outcomes for cognitive-behaviour therapy (CBT) in randomised controlled trials (RCTs) have rarely been compared to those in routine clinical practice. Taking the case of CBT for chronic fatigue syndrome (CFS), we evaluated the results of a successful RCT against those of the same treatment given in the same setting as part of routine practice. Fatigue and social adjustment scores were compared for patients who received CBT for CFS as part of a RCT (N=30) and patients who received CBT as part of everyday clinical practice (N=384). The results in the RCT were superior to those in routine clinical practice. Between pre-treatment and 6-month follow-up, the RCT showed a larger reduction in fatigue and greater improvement in social adjustment than those in routine treatment. The changes in fatigue scores were similar for both groups during treatment but were greater in the RCT between post-treatment and follow-up. Potential reasons for the superior results of the RCT include patient selection, therapist factors and the use of a manualised treatment protocol. Practitioners need to pay particular attention to relapse prevention and ensuring adequate follow-up in addition to encouraging patients to continue with cognitive-behavioural strategies once treatment has ended.