BIOSTATS6004 Design Of Randomised Controlled Trials

Question Assignment (1000 words) Your task is to write a brief proposal for an RCT for an intervention of your choice. This should be for a non-pharmacological intervention, instead focusing on a psychological or psychosocial intervention. This proposal should be written as if submitting to an imaginary grant funding body. Your aim is to convince the funding body that the RCT you propose is valuable, rigorous and robust and thus should be funded. Your proposal should not exceed 1000 words and should comprise the following sections: Background – briefly describe the key research question, making reference to relevant background literature and why your proposed RCT is valuable and robust. Hypotheses – outline one or two key hypotheses Methods – describe the RCT– make sure to include: Design (number of groups / conditions) Sample (size and details) The primary outcome and additional measures/data Discussion – What are the broader implications of the predicted outcomes of the RCT? What additional or future studies might logically follow? Are there are any key limitations of the current study? Answer Introduction Medical studies are not only minds consuming but are also demanding in terms of training. As a result, students pursuing medical courses are at the prevalence of developing psychological distress. Studies suggest that compared to other populations, medical students are at the risk of contracting mental disorders (Voltmer et al., 2015). In the past, there have been several programs aimed at reducing and managing stress in medical schools, results of which indicate a reduction in psychological distress and improvement in performance. However, these training programs are minimal, few institutions can access them, and the providers have got busy schedules (Voltmer, Kötter and Spahn 2012). This renders the training as rare events. This, therefore, means that a rigorous scientific method is deemed appropriate to enhance stress management among medical students. This paper will present a randomized control trial aimed at examining the effectiveness of the specially developed mindfulness-oriented stress management program in lessening stress levels amongst medical learners in training institutions. Scientific studies highlight that burnout symptoms in medical students are in range of 45-71 percent. The studies also suggest a rise in psychological morbidity among the students. Higher symptom loads are also evident, and this may result in mental disorders (Dahlin, Joneborg, and Runeson 2015). The effect of stress varies depending on how long the students have stayed in the learning institution. In a different study by IsHak et al., (2013), different students scored different marks on Patient Health Questionnaire (PHQ) based on the stages of their training. The questionnaire was based on the depressive syndrome and anxiety syndromes. Students in their first, second and third year of the study reported the poorest mental health score based on the Short Form-12 Health Survey. The results suggest that the longer one continues to learn, the more the stress they develop and consequently a poor mental health. Different studies by Seliger, and Braehler (2007) convey the same findings. It is therefore clear that multiple studies portray a high level of psychological distress among medical school students. Objectives of the Study To investigate how effective a mindfulness-oriented stress management program can be in lessening stress levels amongst medical learners in training institutions. Hypothesis H0; Stress prevention training/programs reduce stress levels among medical students H1; Stress management is associated with minimal chances of psychological distress and disorders Methodology The randomized control trial will encompass four assessments. A baseline assessment, post-intervention, one year and 5- year follow up test. They are all time-based. The protocol will address three groups of people, control, standard treatment and experimental treatment. Selection of participants is done randomly (Guthrie et al., 2008). Recruitment of the Participants The subject will be selected from second to eighth-semester students pursuing medical courses. Other students to be considered are those from dental studies because their learning is analogous to those of medical pupils (Midtgaard, Ekeberg, Vaglum, and Tyssen 2008). The trial will involve approximately 470 students from Johannes Gutenberg University, and the distribution will be as follows; 200 medical students and 50 dental students in their second semester and an equal number from the eighth semester. A minimum of 30 percent of the participants are expected to be enrolled in the initial semester and regarding the five years follow up assessment, a 50% drop out of the initial figure is anticipated (Dahlin, Joneborg, and Runeson 2015).. Randomization With regards to treatment, participants will be allocated to either Autogenic, MediMind or control group. Autogenic training will represent the standard group while MediMind is the experimental treatment. Students are randomized based on their course; medical or dental, their stage of learning; second or eighth semester and finally based on their gender; male or female. This was aimed at preventing confounding as well as allowing for the homogenous distribution of participants among the three groups (Aktekin,et al,. 2011). The ratio of allocation is 2:2:1 for Autogenic training, MediMind, and control respectively. All participants are notified of the groups they belong to, and after the five years, all will be invited to fill out a questionnaire (Shapiro, Shapiro, and Schwartz 2010). Trainers and Intervention The two treatment groups will meet for six weeks and on a weekly basis, with each session being 1.5 hours. Within this period, training information and assignments will be handed over to the groups. Four trainers will present the invention and training to the standard and experimental group of students. Besides, two clinical psychotherapists experienced in mindfulness meditation will be deployed for the experimental group. Outcome Tools Upon completion of each assessment time points, the participant will fill in the same questionnaire along with standard demographic measures. This takes approximately 45 minutes. The primary outcome tools include Tier Inventory for the Assessment of Chronic Stress and brief COPE. The secondary outcome measures will be the Brief Symptom Inventory (BSI) while the additional or another criterion will be the Response Style Questionnaire (RSQ) and Freiburg Mindfulness Inventory (FMI) (Kuhlmann, Bürger, Esser, and Hammerle, 2015). Discussion The objective of the study is to investigate how effective a mindfulness-oriented stress management program can be in lessening stress levels amongst medical learners in training institutions. Having worked on the confounding aspect of the randomized controlled trial, the data obtained will be analyzed based on experimental design. The success of the study depends on motivational bias among the selected participants. Studies show that only highly motivated students volunteer to participate in weekly training (Dyrbye, Thomas and Shanafelt, 2006). The other important consideration is the workload on the students. Indeed they have a curriculum to cover and other studies must take this into consideration. Further, response rates on completion of the assessments might be affected because it’s almost impossible to collect data at the end of the last training session. Typically, students will be requested to submit their questionnaires after that (Dyrbye et al., 2014). As regards to motivation and rate of dropouts, the numbers are expected to rise in the control group as they do not benefit from any form of training. This is also likely to impact data collection. Regardless of the above-mentioned limitations, the study will explore one of the possible ways of alleviating stress among medical students. This will consequently eliminate the chances of contracting psychological distress and psychological disorders (Moffat, McConnachie, Ross, and Morrison, 2004).

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