Med5351 Research In Medicine | Assessment Answers

Answer:

Introduction

Depression poses a significant negative impact on the heath and the quality of life of the soccer players with injury. Given the high rates of depression among the soccer players with injury very little is known about the effective of the antidepressants. Very little research has been done related to the psychiatric or the psychological issues in the field of the sports medicines.

There is a critical need to combat against depression and other mental injuries in athletes as stated by (32). This paper describes about the effect of the antidepressants like paroxetine and Bupropion studied in small trials, but the studies were inconsistent and could not prove many effects in the treatment of depression (25).   In the ISSP survey it has been found that majority of the scientist has prescribed fluoxetine for treating depression in the adults other than other antidepressant medications like clomipramine, fluvoxamine,

nefazodone, and paroxetine, because of the activating property than its sedative property. Prozac is a drug that has its mode of action similar to that of fluoxetine. Conversely the study have also demonstrated adverse effect of fluoxetine, such as sweating, decreased sex drive, nausea, which proves that there is a lot of research still to be made to find the impact of this sort of antidepressants. One of the important finding is that no difference has been found between fluoxetine and placebo in the ergometer test of fatigue, power and anaerobic capacity that indicates that the medications does not affect the athletic performance, and hence can be used as antidepressants.

The importance for this study stems from the fact that it researches whether Prozac can be used to alleviate or reduce the psychological symptoms. If the study turns out positive it will have a sizable impact on how athletes are usually treated for depression and similar mental injuries. It is stated that there is a vital need for similar studies pertaining to these facts as they can be fundamental in the field of soccer and can allow athletes a much easier time in in the rehabilitation process (25).

It is assessed that a similar study was conducted by (22) which took a look at the rate of injured athletes and the rate of recoveries using specific drugs. This study was to find out the effectiveness of ketamine, an inotropic glutamatergic N-methyl-D-aspartate (NMDA) receptor blocker showing the fast acting antidepressant actions. The effect of the ketamine have been found to be dependent upon the brain derived neurotropic factors (BDNF) and the activation of the high affinity BDNF receptor.  One of the important finding of the paper was that ketamine has a rapid antidepressant effect in depressed individuals, however it remains unclear whether routine use of ketamine can be used without having any adverse effects. Another limitation of the study was its small sample size that questioned the validity of the research. The article also raises a question as to whether the antidepressant would produce the effect in a large population within a time frame with limited side effects and whether it would provide a long term sustained relief. The synaptic mechanism of ketamine is still not clearly understood.

All these studies have provided the rationale for finding an appropriate drug for the treating depression in injured athletes.

Aim and Objectives

The purpose of this paper is to explore the effects of Prozac on injured athletes. It compares treatment group and placebo group to obtain the significance of the drug. The paper critically examines how antidepressants (Prozac) can impact the treatment of an injured athlete.

The principal objective of this study is to understand and comprehend the extent to which Prozac aids athletes in dealing positively with brain injuries, decrease recovery time, and shun a recurrence of a similar injury. The study conducts an intervention between the placebo group and the treatment group to establish the effects of the drug. The study is proposed after realizing that patients with brain injuries more often recover after being prescribed for an antidepressant.

Another objective is to observe whether or not there is a corresponding relationship between the dosage of Prozac and the rate of recovery from depression or memory loss among patients. The placebo group would be used as a control for testing the medical therapy of the drug.

It shall also be determined if the drug has some side effects on the patients. In the same vein, the research is expected to tell whether depression is a byproduct of unfortunate or sudden changes in circumstances which the athletes find themselves or whether depressions are the direct consequences of the damage of the brain.

Hypothesis

• H₁- Participants subjected to prescribed doses of Prozac will show an improvement in their depression recovery rates, upon comparison to the placebo group.
• H₀- Prescribed doses of Prozac will not show any significant improvement in the depression recovery rate of the participants, when compared to the placebo group.

Research Plan

The research is based on an intention to treat analysis (ITT) where all athletes, who will be randomly allocated to the intervention and control group, following their recruitment, will be included in the analysis in the groups to which they will be randomised. This ITT will result in unbiased comparisons between the Prozac and placebo treatment groups. The research plan will encompass a physical examination of the athletes, with a prior history of depression and brain injuries (1). This will involve a sampling of the individuals, with the aim of obtaining relevant information on the potential benefits and contraindications of Prozac. The study will also encompass conduction of a thorough interview of medical officers on their experiences with the administration of the drug for treating injuries (12). This will be facilitated by visiting several health facilities for collecting data. Following formulation of a hypothesis, a range of assessments will also be conducted for two weeks, for determining potential effects of Prozac. The interviews will be conducted over a period of 1 ½ months. Different practitioners will be scheduled to examine the experiment for obtaining a clear answer to the hypothesis. This will be followed by publication of a report. The study is anticipated to cover three months. The research will also involve use of a questionnaire. Thus, it would adopt a triangulation approach.

Participants

The research participants would include 3 clinicians, 50 undergraduate practitioners (28 male and 22 female) many who received extra credit in the university course, and two professional practitioners. As such the mean university grade point average would be 4.17. Potential participants would be excluded if anyone of them is taking special medication, menstruating, or has no clue on the role of antidepressant. Current soccer players, with previous brain injuries and doctors who have prescribed drugs for depression and anxiety will be selected. The sample (N) is expected to involve not more than 150 people.

Study Design

The research would adopt both an experimental and non-experimental approach, in the form of a randomised controlled trial (RCT). Athletes will be randomly allocated to either of the two groups, the intervention and the control group, respectively, and will be blinded to the treatment. Masking relevant information about the intervention will reduce or eliminate bias in the trial outcomes. The number of participants for the trial would be less than 150 subjects. The athletes in the intervention group will be instructed to take the drug Prozac at a dose of 20mg/day. Participants in the control group will be subjected to administration of similar looking placebo pills that would act as fake medication. After two weeks, those who showed intolerable side effects and without any major improvement will be given a higher dose of two capsules of Prozac (40mg/day or placebo). The dosage will be titrated down to 10mg/day for participants who report adverse effects. All kinds of non-pharmacological interventions for depression, such as, psychotherapy, and light therapy will be prohibited. Weekly assessments will be conducted for the intervention and control group to determine the recovery of the subjects. Power analysis will be used for determining the sample size. Significance level will be assumed at 5% and power level at 80%. The study will have a tighter control on the variables and will allow easier time for commenting on the cause and effect scenarios.

Data Collection

Self-reported questionnaires comprising of measurements obtained from the integrated frameworks would be returned before any athlete leaves the hospital. A research assistant would be available to help in the process of completing the questionnaires. Experiments would also be conducted by the placebo group on the effects of the drug. All the data gathered will be thoroughly documented and used only after the express permission of the participant. Any participant who is unwilling to have his data published in literature will have his data discarded form the documentation.

The data of the placebo group will also be analyzed and a comparison shall be drawn with the data of the treatment group to assess and document the level of improvement or lack thereof that has been observed in the treatment group.

Study variables

Explanatory variable

The resources for symptoms interpretation would be measured by assessing the characteristic symptoms of anxiety and depression. Depression would also be measured using the Beck Depression Inventory. Adding the individual scores for all 21 questions will help in evaluating the depression scale among the participants. Demographic characteristics would be collected from medical records and would include status, age, the type of race one participates in, and the duration since one started taking part in athletics.

Data Analysis

Analyses would be conducted by using the 14.0 version of the SPSS software for windows. The randomized controlled trial would test the null hypothesis (H₀) and the alternative hypothesis (H₁). To accomplish whether (H₁) is correct, the study would begin testing from (H_O). The research inference of accepting the alternative hypothesis and rejecting the null hypothesis will depend on an error of α =0.05. The statistical power would be (1-?, 80%) (20). Notably, a sample of not more than 150 would be used, and the power for the assessment of closer fit is expected to have an estimation of 1, to signify a high power. In designing as well as analyzing the clinical trial, two primary issues associated with patients’ heterogeneity have to be taken into account including the effect of bias and the effect of chance. It is important to note that these two primary issues would be addressed by enrolling an adequate number of patients in the research and utilizing randomization for the treatment assignment. The ITT evaluation of data outcome will include all persons randomized and accounted in their specific groups. Factorial designs will also prove useful since they will help in reducing all forms of inefficiencies by addressing more than a single comparison intervention in a single trial. The study would employ observation recording forms, FGD figure guides, questionnaires, and medical reports in gathering or collecting data.

Reliability and Validity   

The reliability and validity of the study would be ensured through engagement of highly professional doctors and clinicians (20). The analysis and verification of results would also involve expert clinicians. Each weekly results shall be critically analyzed by doctors and professionals. Any undesired variable shall be struck immediately from the record to ensure reliability. Based on the differences in depression recovery rates between the intervention and placebo group, a conclusion shall be drawn.

The doctors will also be in charge of overlooking the procedure to ensure no variable or inconsistency occurs and that the research is conduced as closely as possible to the proposed methods

Project milestone

Ethical considerations

The study would only involve medical doctors, and soccer athletes who have suffered from brain injuries and depression. The research would take into account the dignity and integrity of the respondents and will avoid leading questions (19). Patients in the clinics would be invited to participate in a face-to-face interaction during the research and would be informed of the aim or objective of the study. Following an ethical approval from the human ethics committee, a written informed consent will be taken from all participants.

Safety Considerations

It shall be ensured that the participants are subjected to no harm during this time while the research is conducted, and that their safety shall be prioritized. They will not be exposed to any experimental treatment. They shall be provided the proper nutritive foods. Weekly reports shall also assess their health and physical conditions that may or may not have been affected by the research protocol.

Follow-up

The injured athletes would have to be followed up on, even after being discharged from the healthcare facility to obtain more information from them regarding the drug effects. This will help in the completion of the study and make it more reliable and valid.

Data Management and Statistical Analysis

The data would be managed through a computerized system. Additionally, the verification of the data is proposed to be done by professional medical practitioners. Some methods of statistical analysis include SPSS version 14.032. The sample size is proposed to be less than 150 since few people take part in professional athletics. Moreover, the mean values of the data obtained in case of both the placebo and treatment groups can be used to generate standard deviation, which would help to determine how much the values of the treated group spread out from the mean or expected vales.

A low standard deviation if obtained would indicate that the values obtained in case of both the placebo and treatment groups is highly significant as it remains close to the expected value, however, if a large value is obtained for the standard deviation, then it could result in questioning the significance of the data. Moreover, a high standard deviation would indicate the presence of some experimental errors resulting in variable values in the same data set. A sample standard deviation will be appropriate for this experiment. A statistical power of (1-?, 80%) is intended for the reliability of the data. The data will also be analyzed by professional and experienced doctors and clinicians.

Dissemination plan

The primary outcome of the RCT results will be shared with the health care professionals in the form of tabular charts and videos. With the help of the seminars the data will be shared with other academic researchers. The same will be shared with the community members through advocacy programme facilitated by nurses. Other mode of building partnerships with the stakeholders and academic researchers to share the findings are   face-to-face or online. If the null hypothesises is accepted the expected outcomes are use of the drug Prozac for treatment of depression among the athletes, provided it is found without any side effects. To avoid any barriers such as trustworthiness, the impact of the data on researchers and success will be measured first. It will be followed by evaluating the sustainability of the data. All the researchers involved in RCT and data interpretation are directly responsible for each step of dissemination plan.  The preliminary findings along with research process will be shared after publishing the paper.

Expected Outcome

The study is expected to show the positive effect Prozac on athletes experiencing depression due to traumatic brain injury.  As evident from the previous research in this field, Prozac aid in generating new brain cells and maintain healthy state. With the help of the proposed RCT, it can be verified if antidepressants play a vital role in the cure or prevention of depression associated with the soccer injuries in athletes (6).   

Primary Outcome

The primary outcome of the research is to determine if the treated group demonstrates positive signs of recovery from the depression after sports injury. This result will lead to acceptance of null hypothesis. It means the assumption that Prozac will help in recovery from depression due to traumatic brain injuries among the soccer athletes will be proved true. Based on which further experiments may be designed or develop concluding evidence.

Secondary Outcome

Physiotherapist who treats the injured athletes may help determine the medication that can be successfully used to mitigate depression. It will help in identifying the major antidepressants (17).  Further research may be conducted based on the RCT results. It may include determining the side effects of Prozac as per the given doses such as weight gain, rashes, and others.  Such side effects may lead to failure of null hypothesis. It will be assessed based on the weekly reports. It may also be determined if the drug is effective for treating anxiety associated with the injuries and if applicable for use in major depressive disorder or post traumatic stress disorder.

Expected Impact

Reports from 2005, highlighted that the most frequent injury is the in soccer athletes is bruising (thrashing, with 33.71%), a result of direct trauma on the player's body, followed by the muscular injury (stretching, muscle rupture, 21.72%) and sprain. Further the report stated that lesions are very common injury in lower limbs especially the knee (24.30%), followed by the thigh (21.71%) and the ankle (12.20%). These injuries are associated with the training and occur during sports event.  The psychological state and contact fractures are other factors associated with the injuries. In another study it is found that a high occurrence of knee sprains, both professional and amateur, is found within 32% and 22% of the players respectively. The intense training and excess participation in games makes the athlete vulnerable to occurrence of brain injuries (muscular and osteon-articular). In lieu of mitigating this problem the expected impact of the RCT results on the sports trainer, physicians and physiotherapists is to have the exemplary behavior in determination of the main anti-depressants to be provided. It will help in quick recovery of the soccer players and return to the normal schedule considering the immense pressure associated with the upcoming events.  Knowing the incidence of traumatic brain injuries to be 36.8% in soccer sports, the prevalence of depression can be determined. These values calls for determining the effectiveness of Prozac and it appropriate dosage for treatment of athletes experiencing depression.    

Problems Anticipated

The project team received limited access to funds to reach as many hospitals as they can to conduct the research. Also there may be also some individuals who may not want to respond to the research questions. Further, realistic field experiment may not be achieved. Since whole population may not be represented, interview method is also adopted.  The evidence of RCT may be supplemented by evidence from other methodologies.

Lay Summary

There is a strong association between athletics and the development of depression resulting from brain trauma.  One of the most extensive researches on the subject shows that a 100 out of 120 players who died, suffered from chronic traumatic encephalopathy. Chronic Traumatic Encephalopathy can be linked to decline in memory, mood and executive function, particularly in the case of players because they are more prone to concussions. Antidepressants have played an important role in helping the players cope with the pain and problems resulting from their frequent mental injuries, which in turn may prevent the development of Chronic Traumatic Encephalopathy in the future (26, 28).

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