Principles for Designing Randomized Preventive Trials in Mental Health: An Emerging Developmental Epidemiology Paradigm

An emerging population-based paradigm is now being used to guide the design of preventive trials used to test developmental models. We discuss elements of the designs of several ongoing randomized preventive trials involving reduction of risk for children of divorce, for children who exhibit behavioral or learning problems, and for children whose parents are being treated for depression. To test developmental models using this paradigm, we introduce three classes of design issues: design for prerandomization, design for intervention, and design for postintervention. For each of these areas, we present quantitative results from power calculations. Both scientific and cost implications of these power calculations are discussed in terms of variation among subjects on preintervention measures, unit of intervention, assignment, balancing, number of pretest and posttest measures, and the examination of moderation effects.     

Factors Associated With Treatment Response in an Internet-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement

Internet-based psychological interventions have proven effective in the treatment of prolonged grief disorder (PGD). Yet, some patients do not benefit from treatment in a clinically significant way. We aimed to examine predictors of symptom reduction in an Internet-based intervention for PGD after cancer bereavement, in order to identify possible treatment mechanisms and discern directions for future intervention design. A secondary analysis of data from a randomized wait-list controlled trial on an Internet-based intervention for PGD after cancer bereavement was conducted. Multiple regression models were used (1) to test for the influence of pretreatment PGD, working alliance, avoidance and gender on PGD symptom reduction; and (2) to explore further predictors of treatment success with a best subset selection protocol. The regression models explained 18% (Model 1) and 34% (Model 2) of variance in symptom reduction. Participants with more favorable symptom change had more severe pretreatment PGD scores and better working alliance. Those with lower social support and less posttraumatic growth experienced more PGD symptom change. In conclusion, therapeutic alliance is an important factor that should be monitored and fostered. Findings regarding social support and posttraumatic growth need further replication and clarification.     

Pilot randomised controlled trial of counselling in a community mental health setting: Pitfalls and learnings

The establishment of counselling and psychotherapy as “evidence‐based” interventions is contingent on the effective implementation of randomised controlled trials (RCTs) in real‐world clinical settings. This paper identifies some of the pitfalls that led to the termination of a practical RCT in a community mental health setting. It reflects upon the significance of the lessons learned by drawing on similar challenges that are documented in the wider literature. Issues surrounding staff turnover, counsellor engagement and procedural clarity are discussed, as is the conflict between the time required for research procedures and counsellors’ clinical time constraints. In our recommendations, we recognise the decisive role of collaboration and counsellor motivation in research partnerships, and the significance of clinical relevance, communication, training and research co‐production in achieving them. Time commitment is identified as the pivotal challenge in the formation and maintenance of collaborative research, but one that also must be overcome for the advancement of the counselling and psychotherapy field.     

急性心肌梗死治疗的临床试验分析

急性心肌梗死是冠心病中的危重症,病死率高。为在现有基础上进一步降低病死率,临床开展了众多针对各治疗策略的大型试验研究。在分析这些临床试验的基础上,从提高梗死血管开通率、改善心肌微循环灌注、挽救心肌和休克治疗四个方面综述了各种治疗策略的优势及不足,以期对临床治疗方案的选择起到借鉴作用。     

Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice?

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Introduction

Cognitive behavioral therapy evolved from systematic studies testing learning theories. This research led to the development of effective treatment approaches for a variety of disorders. In more recent years we have moved away from relying on experimental psychopathology studies to directly inform our treatment approaches. This paper describes why the alienation from experimental psychopathology studies is detrimental to the advancement of treatment approaches. Examples of how systematic research can be conducted to address questions regarding treatment mechanisms and moderators are provided. Drawing on experimental psychopathology research can also lead to a better understanding of core processes of psychopathology, which in turn can lead to transdiagnostic treatment approaches.     

Cognitive testing of an instrument to evaluate acceptability and use of pre-exposure prophylaxis products among women

Given the range of pre-exposure prophylaxis (PrEP) products currently being tested to prevent HIV in women, a standardized Acceptability and Use of PrEP Products Among Women Tool may facilitate comparisons of product acceptability and use across different geographies, trials, and users. We conducted three rounds of cognitive interviewing over 2 months in 2016, with 28 South African women who had experience participating in a range of PrEP product trials. The final instrument contained 41 items, including five new items that improved construct validity and 22 items modified for clarity. Changes were made due to unclear wording, difficulty answering, participant embarrassment, low response variability, and administrative formatting. Cognitive interviewing provided a means to address issues that would have inhibited this tool's ability to accurately collect data otherwise. This rapid, low-cost study provided valuable insight into participants' understanding of questions and demonstrated the utility of cognitive interviewing in international clinical trials.