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.     

Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial

Clinician-guided Internet-based cognitive behavioural therapy (iCBT) programs are clinically effective at treating specific anxiety disorders. The present study examined the efficacy of a transdiagnostic Internet-based cognitive behavioural treatment (iCBT) program to treat more than one anxiety disorder within the same program (the Anxiety Program). Eighty six individuals meeting diagnostic criteria for generalized anxiety disorder (GAD), panic disorder, and/or social phobia were randomly assigned to a treatment group, or to a waitlist control group. Treatment consisted of CBT based online educational lessons and homework assignments, weekly email or telephone contact from a clinical psychologist, access to a moderated online discussion forum, and automated emails. An intention-to-treat model using the baseline-observation-carried-forward principle was employed for data analyses. Seventy-five percent of treatment group participants completed all 6 lessons within the 8 week program. Post-treatment data was collected from 38/40 treatment group and 38/38 control group participants, and 3-month follow-up data was collected from 32/40 treatment group participants. Relative to controls, treatment group participants reported significantly reduced symptoms of anxiety as measured by the Generalized Anxiety Disorder - 7 Item, Social Phobia Screening Questionnaire, and the Panic Disorder Severity Rating Scale - Self Report Scale, but not on the Penn State Worry Questionnaire, with corresponding between-groups effect sizes (Cohen’s d) at post-treatment of 0.78, 0.43, 0.43, and 0.20, respectively. The clinician spent a total mean time of 46 min per person over the program, participants rated the procedure as moderately acceptable, and gains were sustained at follow-up. Modifications to the Anxiety program, based on post-treatment feedback from treatment group participants, were associated with improved outcomes in the control group. These results indicate that transdiagnostic programs for anxiety disorders may be successfully administered via the Internet.     

Efficacy of self-administered treatments for pathological academic worry: A randomized controlled trial

Research on treatments for reducing pathological worry is limited. In particular, academic worry is a common theme in generalized anxiety disorder (GAD) samples as well as non-clinical student samples. Given the high cost of anxiety disorders to society, research is needed to examine the efficacy of self-administered treatments designed to reduce pathological worry. The primary goal of this study was to investigate the benefits of three self-administered interventions for reducing academic worry. College students (N = 113) experiencing clinically significant academic worry were randomized to either: (a) worry exposure (WE); (b) expressive writing (EW); (c) relaxation consisting of pulsed audio-photic stimulation (APS); or (d) waitlist control (WLC). Participants were instructed to practice their interventions three times per week for one month and completed home practice logs online to track treatment adherence. Academic worry, general anxiety, and perceived stress were assessed at baseline and post-treatment. Academic worry and general anxiety were also assessed at a three-month follow-up. Those assigned to the WE and APS conditions showed significant improvement relative to EW and WLC at post-treatment. All treatment conditions showed continued improvement by follow-up, with no between-group differences. Treatment and public health implications are discussed.     

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.     

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.     

A randomized pilot study of anger treatment for Iraq and Afghanistan veterans

Objective

Anger and aggression are serious problems for a significant proportion of veterans who have served in combat. While prior research has suggested that cognitive behavioral treatments may be effective for anger problems, there are few controlled studies of anger treatment in veterans and no studies of anger treatment focusing exclusively on veterans from the Iraq and Afghanistan wars. This randomized pilot study compared an adapted cognitive behavioral intervention (CBI) to a supportive intervention (SI) control condition for the treatment of anger problems in veterans returning from deployment in Iraq or Afghanistan.

Methods

25 veterans with warzone trauma, problems with anger, and one or more additional hyperarousal symptoms were randomized and 23 started treatment (CBI, n = 12; SI, n = 11). Outcome measures were administered at pre- and post- treatment and at 3 months post-treatment.

Results

CBI was associated with significantly more improvement than SI on measures of anger and interpersonal functioning. Gains were maintained at follow-up.

Conclusions

Findings suggest that CBI may be more effective than an active control providing psychoeducation, relaxation, and supportive therapy for treating anger problems in returning veterans. The findings need to be replicated in an adequately powered and more diverse sample.     

Combining Pharmacotherapy with Cognitive‐Behavioral Interventions for Obsessive‐Compulsive Disorder

This paper reviews the evidence‐based literature concerning the efficacy and effectiveness of cognitive behavior therapy (CBT), drug treatment and their combination for obsessive‐compulsive disorder (OCD). After a brief outline of the seminal studies, the state of the art is presented with reference to the consensual recommendations proposed in the last 10 years. Management of OCD rests on potent selective serotonin re‐uptake inhibitors and CBT, used separately, sequentially, or concurrently. A hierarchical model for clinical decision‐making is reported. With greater severity of OCD, it is recommended to add medications. However, the response rate is still too low in many patients, and some patients remain refractory to any kind of treatment. This stresses the importance of joint efforts of psychological and biological teams to develop new treatments.     

Psychotherapy and (or) Medications for Depression in Youth? An Evidence-Based Review with Recommendations for Treatment

This article reviews existing research pertaining to antidepressant medications, psychotherapy, and their combined efficacy in the treatment of clinical depression in youth. Based on this review, we recommend that youth depression and its treatment can be readily understood from a social-psycho-bio model. We maintain that this model presents an alternative conceptualization to the dominant biopsychosocial model, which implies the primacy of biological contributors. Further, our review indicates that psychotherapy should be the frontline treatment for youth with depression and that little scientific evidence suggests that combined psychotherapy and medication treatment is more effective than psychotherapy alone. Due primarily to safety issues, selective serotonin reuptake inhibitors should be initiated only in conjunction with psychotherapy and/or supportive monitoring.     

An online hazard perception training course reduces heavy braking,speeding, and over-revving rates during everyday driving

In essence, driver training involves learning the skills required to drive safely and avoid dangerous events. However, in traditional on-road driver instruction, drivers virtually never accrue experience of the most significant types of events that they are learning to avoid: crashes. One means of providing this experience safely is to present novice drivers with video clips of real crashes, as part of structured learning exercises. A six-week automated online hazard perception training course for drivers, incorporating evidence-based training methods and over a hundred crash clips, was previously found to improve novice drivers’ hazard perception skill, which is known to be an important attribute for avoiding crashes. However, since hazard perception was measured using computer-based methods, the possibility remained that the training effect might not transfer to actual driving. We report a randomized control trial in which novice drivers were recruited to assess everyday driving behaviour objectively, using g-force triggered dashcams and GPS trackers installed in their vehicles. On-road data were collected for a one-month baseline period, and for a further two months after half of the sample completed the hazard perception training course. Drivers who completed the course significantly reduced their rate of heavy-braking events, their speeding behaviour, and their rate of over-revving events. These findings support the proposal that a relatively inexpensive and highly scalable hazard perception training intervention can improve on-road driving behaviour, with the clear potential to impact real-world driver safety.     

Early childhood education and crime

This article presents new evidence on the crime-reducing impacts of a high-quality, intensive early childhood program with long-term follow-up, evaluated by a randomized controlled trial. Proportionately, more women than men decrease their criminal activity after participating in the program. This gender difference arises because of the worse home environments for girls, with corresponding greater scope for improvement by the program. For both genders, treatment effects are larger for the least-advantaged children, as measured by their mother's education at baseline. The dollar value of the social cost of criminal activity averted is higher for men because they commit more costly violent crimes.