Clinical Research: Cognitive Therapy vs Anti-Depressants Treatment

This report provides an overview of clinical research on depression treatment, specifically comparing cognitive therapy and antidepressants. It discusses various trial designs such as parallel group, factorial, crossover, and cluster trials, along with considerations for allocation ratios and potential changes to methods during trials. The report details participant eligibility criteria, recruitment methods, and the importance of appropriate medical interventions, emphasizing the need for careful selection and timing. It further classifies outcome measures into primary and secondary outcomes, addressing potential changes and the significance of sample size determination through methodologies like formal power calculation and underpowered trials. The report also touches on randomization methods, including sequence generation and allocation concealment mechanisms, highlighting their role in preventing selection bias. Desklib provides past papers and solved assignments for students.

Running head: CLINICAL RESEARCH
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Clinical Research
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Institutional Affiliation
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Treatment of depression, cognitive therapy vs anti-depressants a randomized controlled
single-blind trial on adults
Abstract
Depression also referred to as the clinical depression is a common and a very serious
medical illness which affects the feelings of the people and the way they think and act.
Depression mainly causes the feelings of sadness, loosing of interests in many activities, loosing
of appetite, affecting the overall moods of people, among other negative effects. There are many
methods which are used in the treatment of depression where the main methods are the
application of cognitive therapy and the use of anti-depressants. Cognitive therapy is a kind of
psychotherapy which entails recognizing and understanding the distorted thinking and of the
victims and learning how to look for some good and appropriate ways to help the victims recover
from their distorted thinking and other mental problems (Segal, Williams, and Teasdale, 2018).
Antidepressants, on the other hand, are the medications or drugs which are given to the people
suffering from depression to help them recover from the mental illnesses (Block and Nemeroff,
2014, pp.7-16). Some of the common antidepressants include fluoxetine, paroxetine, citalopram,
sertraline, among many others. Antidepressants have been proved to be more effective than
cognitive therapy in the treatment of depression.
Trial designs and methods entail the formulation of the specific trials and experiments
which are aimed at improving the medical performance of the depression victims. Some of the
major trial designs include the parallel group trials, the two-arm trials, the cluster trial designs,
crossover trial designs, among many others (Buyse and Michiels, 2013, pp.289-295). All these
trial designs and methods result in improved health conditions of the depressed patients and we

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can conclude this section by saying that the medical officers should choose the best trial design
and method which will help his/her depression patients to recover.
Introduction
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.
The methods
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.

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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.

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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

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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.

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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.

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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

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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

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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.

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References
Block, S. G., & Nemeroff, C. B. (2014). Emerging antidepressants to treat major depressive
disorder. Asian journal of psychiatry, 12(3), 7-16.
Buyse, M., & Michiels, S. (2013). Omics-based clinical trial designs. Current opinion in
oncology, 25(3), 289-295.
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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outcomes: a systematic review of trials with both blinded and nonblinded
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Hung, C. F., Rivera, M., Craddock, N., Owen, M. J., Gill, M., Korszun, A., & Rietschel, M.
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