Effectiveness of Supplementary Cognitive-Behavioral Therapy (CBT) over Pharmacotherapy for managing Depression

This research study aims to examine the effectiveness of Supplementary Cognitive-Behavioral Therapy (CBT) over Pharmacotherapy for managing Depression in patients. The study design, population of interest, proposed methods, ethical considerations, and timeline are discussed.

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Table of Contents
1. Study Title...................................................................................................................................3
2. Introduction..................................................................................................................................3
3. Background..................................................................................................................................3
4. Study Aim....................................................................................................................................5
5. Proposed Methods.......................................................................................................................5
Design..........................................................................................................................................5
Population of interest...................................................................................................................6
Sample and sampling approach....................................................................................................6
Intervention (if applicable)...........................................................................................................7
Data collection approach..............................................................................................................7
Data management and analyses...................................................................................................8
6. Ethical Considerations.................................................................................................................9
7. Timeline.....................................................................................................................................10
8.Feasibility / Resources................................................................................................................11
9. Reflection...................................................................................................................................13
10. References................................................................................................................................14
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1. Study Title
The Title of this Research Study is "Effectiveness of Supplementary Cognitive-Behavioral
Therapy (CBT) over Pharmacotherapy for managing Depression".
2. Introduction
Depression refers to a mental ill-health experienced by an individual, that brings a persistent
feeling of worthlessness and despair, making that individual to lose joy from his/her daily life. It
is one of the serious disorder that interrupts the normal activities of a person, causes pain and
ultimately leads to suicide in many cases. Though being one of the most severe cases, depression
is a highly curable disorder. It all depends on how early it is diagnosed and treated. According to
the World Health Organization, untreated depression causes of over 700,000 suicides across the
world every year (Hofmann, and Otto, 2017). The earlier that treatment is started, the more
successful it is in preventing the recurrence of depressive disorder. The previous researches on
psychoanalysis for depressive disorder have come up with a number of therapies for managing
the problem of depression, such as Cognitive Behavioral Therapy, Psychodynamic Therapy, and
pharmacotherapy. In this context, this research study aims to examine the effectiveness of
Supplementary Cognitive-Behavioral Therapy (CBT) over Pharmacotherapy for managing
Depression in patients.
3. Background
In the recent years, Cognitive Behavioral Therapy (CBT) has become an effective treatment for
the patients whose depression has failed to respond towards anti-depressants. CBT works by
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making clients to learn a series of behavioral and cognitive skills that they can apply on their
own. However, the long-term results of using CBT are not known yet. In a constant follow-up
process of the CoBalt Trial, the cost-effectiveness and clinical behavioral therapy has been
investigated as an addition to the patients' normal care routine (Seki et al., 2016). It involved
medication for 4-6 years in primary care clients suffering with treatment-resistant depression.
An adequate amount of evidences have also been found regarding the use of combined treatment
for dealing with the issues of major depression, obsessive-compulsive disorder, and panic
disorder. The outcomes of the combined treatment were observed twofold as large as those of
pharmacotherapy, thus emphasizing upon the experimental advantage of combined treatment. In
addition to this, in many circumstances from mild to severe depression, CBT has also been
applied successfully as standalone treatment. A range of meta-analysis have been carried out in
the past, about the combination of pharmacotherapy and psychotherapy for the patients, and have
come up with an benefit over the use of either treatment alone (Park et al., 2017). This benefit
was specifically evident mainly in those patients suffering from chronic or extreme recurrent
depression, and hospitalized patients.
From the past clinical researches in the National Institute of Mental Health Treatment of
Depression Collaborative Research Program (TDCRP) , it has been found that pharmacotherapy
was better than cognitive behavior therapy (CBT) in the severe diagnosis of depressed clients.
However, this verdict was neither consistent throughout the sites within the TDCRP nor robust
with the findings of other researches. Moreover, many scholars have argued that those other
researches were innately inconsistent due to exclusion of pill-placebo controls. Although this had
been established that the inclusion of such controls would have enabled flawless interpretation of
findings, it was not established that their non-inclusion made those researches uninterruptable.
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Since many years, CBT has been a feasible alternative to pharmacotherapy for treating the issue
of depression in an effective manner, and a successful intervention for the treatment of this
serious disorder.
In addition to this, the previous studies have also suggested that the impact of pharmacotherapy
are not interrelated at all, with both of them largely contributing to the results of combined
treatment (Trauer et al., 2015). Thus, it has been identified that a combined treatment can be
more successful than treatment with CBT or pharmacotherapy alone, in the situations of major
depression, OCD, and panic disorder.
4. Study Aim
The aim of this research paper is to determine the Effectiveness of Supplementary Cognitive-
Behavioral Therapy (CBT) over Pharmacotherapy for managing Depressive Diorder.
5. Proposed Methods
Design
The researcher has employed various strategies for identifying the appropriate literatures. Four
key bibliographical databases are also used by the researcher, that are PsycInfo, PubMed,
Cochrane, and Embase database of randomized trials. For the purpose, the researcher has
designed a search string for psychotherapy with text signifying the several types of CBT and
psychotherapy treatments. However, in this study, the research was restricted to randomized
controlled trials only. Also, the researcher has verified the references of 8 previous meta analysis
of treatments of depressive disorder. Randomized trials have been also included wherein the
outcomes of treatment with CBT therapy are compared with the outcomes of pharmacotherapy,
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and a mix of both the therapies in individuals suffering with panic and depressive order (Huguet
et al., 2016). Only those literatures in which the research topic has met the diagnostic norms for
the disorder as per the diagnostic interview are included in this research, such as the Composite
International Diagnostic Interview (CIDI), Mini-International Neuropsychiatric Interview
(MINI), and Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). However, the
studies on teenagers, children, and inpatients are not included in this study.
Population of interest
In this research, 15 depressed patients have participated in the Cognitive Behavior Therapy,15
patients in pharmacotherapy, and other 10 patients participated in the combined treatment. Three
studies were aimed at major depression issue, and one was aimed at patients having both OCD,
and major depression. In addition to this, two studies were aimed at anxiety disorder (one on
panic disorder with or without agoraphobia (Cristea et al., 2015). More than half of studies
recruited patients from experimental samples, aiming at adults rather than focusing on a more
specific population like older people. However, many of the psychotherapies were from the
group of CBT, and some were focused on pharmacotherapy, while a were focused on examining
other therapies such as psychodynamic therapies. The number of treatment programs were
ranged from 3 to 10, with most therapies between 2 to10 sessions.
Sample and sampling approach
The effective sample size was estimated for each comparison between the cognitive behavioural
therapy, and pharmacotherapy, along with the combined treatment group. This sample effect size
was determined by subtracting the average score of the CBT group from that of the
pharmacotherapy group and combined treatment group, thus separating the effect using joint
standard deviation. Since some studies had quite small sample size, the researcher rectified the
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effect size to remove small sample prejudices (Fernandez et al., 2015). It has also been found
that the difference between CBT and pharmacotherapy was high particularly in clinical samples
in comparison to community recruited samples. Although this difference was only a bit large
(p<0.1), it indicated that patients actively taking treatment are likely to benefit more from
combined treatment than those who seek for CBT or pharmacotherapy treatment .
Intervention (if applicable)
In this research, CBT intervention has been applied. Cognitive behavioral therapy belongs to the
family of interventions that are among the most common and frequently used, and empirically
supported treatments for depressive disorder. Also, there exist many diverse specific
interventions that differ in their constituent components, with CBT being one of the widely
applied practice. However, all such interventions are directly associated with each other. CBT
intervention has been used on the belief that maladaptive information system plays a connecting
part in the management of depressive disorder (Cuijpers et al., 2016). This ‘cognitive model’
speculates that when maladaptive process is corrected, both severe suffering and the risk for
subsequent indicator return are minimized significantly. In this paper, the researcher has
emphasized upon the effectiveness of CBT alone in the treatment of serious stage depression and
the avoidance of subsequent symptom return especially in adult populations, with a main focus
on the control and intercession of response.
Data collection approach
For the purpose of this research, qualitative methods have been used by the researcher because
this method is helpful in drawing out the outlooks of prior studied literatures. Qualitative
methods enable the people to represent the facts in their own voice without taking confirmation
from others or complying with the terms imposed by them. By analyzing the perspectives of
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participants, the qualitative methods would helped the researcher in increasing the reliability and
accuracy of the data being gathered. This method has allowed the researcher to honestly compare
his/her own opinion of reality with the results of those which are being reviewed (Fernandez et
al., 2015). Also, the qualitative method have proved to be more appropriate during the beginning
of the research as the researcher became able to gain a good understanding of the issues for
acquiring sample data. It has involved an investigation of the experiences of health professionals
who had met immigrant patients in their services on regular basis. It has also helped the
researcher to have a look into the areas where difficulties might occur and how to deal with these
while serving mental health services. Moreover, this data collection method has allowed the
researcher to discover the wraparound services for patients above 18 years of age suffering
serious depressive disorder.
Finally, qualitative methods have been used in this research study for an effective assessment of
process, to explain how an intervention or a clinical program runs. Such methods have provided
a useful insight as to why a particular therapy standalone cannot work to arrive at the intended
outcomes or benefits.
Data management and analyses
In this study, data management and analysis was carried out by 2 external reviewers who used an
explicit work sheet chosen before the literature search. For the purpose, a consensus conference
was conducted with a third investigator to resolve inconsistencies between the 2 reviewers. Data
analysis was held from full-text versions of the RCTs, where available. In addition to this, a
quality-control practice was also undertaken for the data management by the third researcher for
validating all the collected data against the original sources (Milgrom et al., 2015). Furthermore,
the data involving crucial characteristics and effect measures, including the study identity, study
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design, country, number of research participants, gender, mean or median age, intervention
characteristics, and other relevant outcomes were managed electronically for all literatures.
6. Ethical Considerations
While designing a clinical therapy treatment study, a number of potential ethical concerns would
be taken into account by the researcher. An effective balance would be made between the general
ethical and scientific rigor principles, particularly in the areas of use of control group or wait list
group, Randomization to treatment, reimbursement for patient involvement, methods of
recruiting patients, registering vulnerable individuals like adolescents, children, and other people
who can weaken the decision as a result of disorder. In this context, the researcher would take
extra care that the rights and dignity of the participants are not hurt during the entire study.
In addition to this, an informed consent of the people would be obtained by the researcher in the
language that is properly understood by those people, before conducting the study or providing
any therapy or counseling services to them either personally or other kind of communication.
However, the consent of individuals would not be required in case the research activity is
compulsory by any government regulation or statue, or as otherwise mentioned in the Ethics
Code. Moreover, the researcher would take the reasonable steps in order to prevent the research
participants from any potential harm, and to reduce the level of risk where it can be unavoidable
but foreseeable.
Furthermore, the researcher would cooperate with other professionals as well when appropriate
and indicated, for the purpose of serving the clients in an effective way. In this regard the clinical
professionals would stop using the therapy if it becomes clear that the clients no longer require
the therapy, or is being negatively affected by the treatment, or is not likely to get any benefit.
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Also, the researcher would not come into several relationships could reasonably be predictable to
weaken the researchers' impartiality, capability, or effectiveness in carrying out his or her
activities as a psychologist, or otherwise risks exploitation to the individual with whom the
professional association is built.
7. Timeline
Resea
rch
Activi
ty
Mont
h
1 2 3 4 5 6 7 8 9 10 11 12
Proposal
development
Proposal
submission
HRE
C
Gover
nance
Site
preparation
Participant
recruitment
Data
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collection
Data management /
analyses
Report
writing
Report for HREC /
governance
Explanatory notes on timeline
The above research timeline shows that the development of research proposal took about one
month. The proposal submission took another one month as the review and approval of the
proposal from the applicable health authority was time consuming. It took around two months to
construct the site where the research activities were carried out. Next, the research participants
were recruited and their consent was taken ethically (Milgrom et al., 2015). This took another
one month for the researcher. Since the data collection method was qualitative, it took one month
to search out and evaluate the previous studies and literatures on effective therapy for dealing
with depression. Data management and analysis took one month as it was performed by the third
party. Finally, the report writing took one month as it included useful but detailed information
relevant for the stakeholders.
8.Feasibility / Resources
Budget Item Cost ($)
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Personnel
Research Analyst 2 100
Research Manager 1 100
Market Researcher 2 100
Data Manager and Analyst 2 150
Equipment
Retrospective records (medical data) 1 50
Laboratory test 1 90
Clinical examinations 1 100
Consumables
Masks 4 40
PET 2 40
medical gloves 4 30
TOTAL 20 800
Budget justification
The above research required submission of a budget justification with all the items mentioned in
the above table. The research personnel were needed to use the equipments and tools.
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Retrospective records were required to assess the relationships between biomedical, therapy, and
demographic variables, and outcomes measures in patients. Laboratory tests were used for
enabling the research professionals to take effective decision making (Ashworth et al., 2015).
Clinical examination was done to obtain clinical information. Similarly, the consumables like
gloves, and masks were used during the study by the research professionals to prevent or avoid
any infection during the processes from patients through nose, mouth and hands.
9. Reflection
From the above health research on determining the effectiveness of CBT for reducing depressive
disorder, I have learnt that CBT in general are as successful as psychotherapy in major
depression, and this decision holds true for both mild and extreme forms of MDD. On the
contrary, pharmacotherapy produces better results in case of dysthymia. However, I have also
reflected that the combination of CBT and pharmacotherapy is somewhat more efficacious than
psychotherapy. A significant drop of patients has been observed from psychotherapy due to the
side effects. However, some degree of prevention needs to be adopted by the psychiatrist in
treating depressive disorder.
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10. References
Ashworth, D.K., Sletten, T.L., Junge, M., Simpson, K., Clarke, D., Cunnington, D. and
Rajaratnam, S.M. (2015) A randomized controlled trial of cognitive behavioral therapy for
insomnia: an effective treatment for comorbid insomnia and depression, Journal of counseling
psychology, 62(2), p.115.
Cristea, I.A., Huibers, M.J., David, D., Hollon, S.D., Andersson, G. and Cuijpers, P. (2015) The
effects of cognitive behavior therapy for adult depression on dysfunctional thinking: A meta-
analysis, Clinical Psychology Review, 42, pp.62-71.
Cuijpers, P., Cristea, I.A., Karyotaki, E., Reijnders, M. and Huibers, M.J. (2016) How effective
are cognitive behavior therapies for major depression and anxiety disorders? A meta‐analytic
update of the evidence, World Psychiatry, 15(3), pp.245-258.
Fernandez, E., Salem, D., Swift, J.K. and Ramtahal, N. (2015) Meta-analysis of dropout from
cognitive behavioral therapy: Magnitude, timing, and moderators, Journal of Consulting and
Clinical Psychology, 83(6), p.1108.
Hofmann, S.G. and Otto, M.W. (2017) Cognitive Behavioral Therapy for Social Anxiety
Disorder: Evidence-Based and Disorder Specific Treatment Techniques. UK: Routledge.
Huguet, A., Rao, S., McGrath, P.J., Wozney, L., Wheaton, M., Conrod, J. and Rozario, S. (2016)
A systematic review of cognitive behavioral therapy and behavioral activation apps for
depression, PLoS One, 11(5), p.e0154248.
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Milgrom, J., Gemmill, A.W., Ericksen, J., Burrows, G., Buist, A. and Reece, J. (2015) Treatment
of postnatal depression with cognitive behavioural therapy, sertraline and combination therapy:
A randomised controlled trial, Australian & New Zealand Journal of Psychiatry, 49(3), pp.236-
245.
Park, J.E., Kim, D., Bae, H., Kim, W.H., Roh, D. and Kim, W. (2017) Augmentation effects of
eye movement desensitization and reprocessing (EMDR) intervention in pharmacotherapy-
resistant PTSD, European Psychiatry, 41, p.S726.
Seki, Y., Nagata, S., Shibuya, T., Yoshinaga, N., Yokoo, M., Ibuki, H., Minamitani, N.,
Kusunoki, M., Inada, Y., Kawasoe, N. and Adachi, S. (2016) A feasibility study of the clinical
effectiveness and cost-effectiveness of individual cognitive behavioral therapy for panic disorder
in a Japanese clinical setting: an uncontrolled pilot study, BMC research notes, 9(1), p.458.
Trauer, J.M., Qian, M.Y., Doyle, J.S., Rajaratnam, S.M. and Cunnington, D. (2015) Cognitive
behavioral therapy for chronic insomnia: a systematic review and meta-analysis, Annals of
internal medicine, 163(3), pp.191-204.
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