Background and objectives
As already stated depression is a kind of a disorder or a disease which affects the feelings of the people by corrupting their mental performance. This disorder is a very common problem in our societies and affects both the old and the young and has very many negative effects on the victims and can even make them kill themselves in extreme cases. Therefore, depression needs medical intervention in its early stages before it can lead to those extreme effects on the patients. Cognitive therapy and the use of antidepressants are among the most common methods applied in the treatment of depression.
The main objective of this paper is to research, understand, and compare the use of cognitive therapy and the use of antidepressants in the treatment of depression.
Another major objective of the paper is to study various trial designs and their application in the treatment of depression.
Trial design
We have many kinds of trial designs used in healthcare organizations. Some of the most common trial designs include parallel group trial designs, factorial trial designs, crossover trial designs, cluster trial designs, among many other trial designs.
To start with the parallel group trial designs, in this trial designs, the participants (the depression patients) are normally assigned some random groups and then treated in their respective groups. After the participants of all the groups are treated, the final results of the treatments are compared to know the most effective treatment method. The factorial trial designs are the trials where two or more treatments are normally given simultaneously to the patients using various combinations of medications and treatments. Crossover trial designs are the clinical trials where the depression patients receive a sequence of several different treatments or medical exposures as the medical officers try to help them to recover from their mental illnesses. Lastly, the cluster trial designs are the trial designs where the subjects (the depression patients) are divided into various random groups and then attended by the medical officers at their random group levels. We have many other types of types of trial designs and the medical officers can decide to use any appropriate trial design in their medical operations. In Consolidated Standards of Reporting Trials (CONSORT), the allocation ratio refers to the ratio of the intended number of participants in each of the created medical comparison groups of the participants or the patients (Eldridge et al., 2016, pp.7-15). In two group trials, the normal allocation ratio is 1:1 but some unequal allocation ratios such as 1:2, 1:3, 2:1 and many others can be used when required.
We may have several important changes to the methods employed after the commencement of the trials. Such changes include the deviations from the originally agreed protocol to follow a better and a more effective protocol, some changes in the treatment regimens, changes in the randomization ratios, changes in the eligibility criteria, among many other important changes.
The participants
The participants in the trial designs are the patients suffering from depression. A detailed description entailing the eligibility criteria was given to different patients and the only eligible patients were the depression patients who could enhance our study of cognitive therapy and antidepressants and their usage in the treatment of depression. The methods of recruitment used to recruit the participants were the referral method or the self-selection method where all the eligible participants were separated from all the other patients.
On top of discussing the eligibility of the participants, it’s also important to discuss the settings and the appropriate locations where the required data was collected. The major aspects of the settings of the participants include their social environment, their economic environment, their cultural environment, among many other aspects which affect the lives of the participants either directly or indirectly. The locations which were used to obtain the patients include the inpatient units, the community clinics, thee major community hospitals, among other healthcare organizations.
The interventions
The appropriate medical interventions are very important in helping the depression patients to recover from their medical illnesses (Gharaibeh et al., 2013). In using antidepressants as an intervention mechanism to help the depression patients, the medical practitioners should be very careful to make sure they give the best and the most appropriate antidepressants which will help the depression patients to recover from their mental illnesses. While using the cognitive therapy as the intervention mechanism, the medical practitioners should make sure to study comprehensively and understand all the feelings of the patients and make sure to monitor and understand their activities for them to make the most appropriate interventions which will have a positive impact to the health conditions of the patients. Whenever making any medical intervention, the medical practitioners should always be very keen to make sure they make the right intervention and at the right time for the benefits of the health conditions of their patients.
The outcomes
Most of the clinical trials have several different outcomes which have different levels of interests. The outcome measures are normally classified into primary outcome measures and secondary outcome measures. The primary outcome measures are the pre-specified outcomes which are considered to be the outcomes of the greatest importance to the relevant medical stakeholders who include the patients, the medical officers, the health policymakers, the clinicians, among other main health stakeholders. Some clinical trials may have more than one primary outcome and these multiple primary outcomes can lead to some problems in the interpretation of the health status of the patients. The clinical trials may yield some additional outcomes which are mainly referred to as the secondary outcomes. These secondary outcomes are the unexpected or the unanticipated outcomes or effects which result from the medical interventions where in our case the main medical interventions are the use of antidepressants and the use of cognitive therapy in the treatment of depression.
We may have some changes to the trial outcomes after the commencement of the trial due to various reasons. Among the major reasons which may lead to some changes in the trial outcomes include the change of the originally agreed protocol, some changes which may be made during the intervention process, some changes which may be made during the analysis of the results, among many other reasons.
The sample size
For ethical and scientific reasons and considerations, the sample size used in clinical trials need to be planed and decided carefully trying to balance the medical and the statistical considerations (Chow et al., 2017). A good research should be done to make sure to produce a good sample size which will be statistically significant and clinically significant and this will result in some good results which can be relied upon. We have several methodologies which have been established to help in determining the best sample size to use in clinical trials. One of the main methodologies used is the formal power calculation where the medical analysts consider many statistical and many medical or clinical aspects when calculating the best sample size to be used in the CONSORT analysis. The underpowered trials methodology is another method used in the determination of the best sample size and this methodology combines a systematic review of all the major medical aspects and some meta-analysis to decide the most appropriate sample size.
In many clinical trials, the participants are normally recruited over long periods. If an intervention is working well and effectively to achieve the desired results, it should continue to be used. However, if the intervention is not working as required, it should be stopped due to the sake of the health safety of the patients. The interventions used should also follow and abide by the ethics and the guidelines of the people and those interventions which tend to break the ethics or the guidelines which lead the people should be stopped. An interim analysis should always be done to make sure the medical interventions applied abide by the rules and the guidelines which lead the people and those interventions which don’t follow the ethics and the guidelines which lead the people should always be stopped or replaced with others.
Randomisation: sequence generation
We have various random methods which are used in the generation of random sequence sequences. Some of the most common methods include the random number table method and the use of computerized random number generator. The sequence is normally generated by the process of minimisation which is a non-random method but this method is normally accepted. Random methods of minimisation are normally preferred to non-random methods in sequence generation and have been successfully used in trials for a long time. Some of the major reasons why random methods are preferred include eliminating the selection bias, allowing the use of probability theory which helps in expressing the likelihood of the occurrence of differences in the outcomes of various interventions.
We have various types of randomisations which are very important in sequence allocation. Some of the common types include simple randomisation, restricted randomisation, and blocked randomisation (Hung et al., 2014, pp.20-28). Simple randomisation is the pure randomisation which is normally based on a single allocation ratio. This randomisation is normally unpredictable and is known in surpassing the bias prevention levels of the other alternatives. Restricted randomisation, on the other hand, is any randomisation approach which is not simple and does not surpass the bias prevention levels of the other alternatives. The blocked randomisation is one of the most common forms of restricted randomisations.
Allocation concealment mechanism
Allocation concealment is mainly meant to prevent selection bias and protecting the assignment sequence until the allocation time. The concealment mechanisms normally incorporate the external mechanisms. Two of the most common techniques used in the concealment mechanism are the use of a pharmacy and the use of central telephone randomisation system. The allocation concealment mechanism prevents the foreknowledge of treatment assignments and therefore shields those who enroll the participants from being controlled or influenced by this knowledge.
Implementation
Implementation is the last phase or stage of randomisation. The randomisation process has three distinct stages which have to be followed for it to be successful. These stages are sequence generation, allocation concealment, and implementation. The implementation phase has various distinct activities which have to be accomplished to make the randomisation successful. These activities include enrolling the participants, assessing the eligibility, discussing the whole trial process, obtaining of informed consent, enrolling the participants on the clinical trial process, ascertaining the intervention assignment, and administering the intervention.
Blinding
Blinding also referred to as masking is the process of withholding information about the assigned intervention from the people involved in trials who may be potentially influenced by the treatment knowledge (Hróbjartsson et al., 2013, p.120744). Binding is a very important process since it helps to safeguard against the selection bias especially when assessing the subjective outcomes. The blinding terminology helps to define the group of the individuals like the care providers, the participants or the patients, the data analysts, among other individuals who can introduce bias through the knowledge of treatment assignments.
We may have some similarities in the characteristics of some interventions such as the appearance, the smells, the tastes, among others and the medical officers need to state and record these similarities before offering the appropriate medical interventions in the trials with the blinding of some participants or healthcare participants. Some healthcare officers have always advocated for testing blinding by asking the participants and the healthcare providers at the end of trials. The authors or the medical officers should always report when it’s unnecessary to unbind any participants at any point in the course of conducting the trials.
References
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Chow, S. C., Shao, J., Wang, H., & Lokhnygina, Y. (2017). Sample size calculations in clinical
research. Chapman and Hall/CRC.
Eldridge, S. M., Chan, C. L., Campbell, M. J., Bond, C. M., Hopewell, S., Thabane, L., &
Lancaster, G. A. (2016). CONSORT 2010 statement: extension to randomised pilot and
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Gharaibeh, A., Savage, H. I., Scherer, R. W., Goldberg, M. F., & Lindsley, K. (2013). Medical
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