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EMDV8008 : Research Proposal

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EMDV8008 : Research Proposal

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Course Code: EMDV8008
University: Australian National University

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Country: Australia


SECTION 1: RESEARCH QUESTION, BACKGROUND AND OBJECTIVES (Limit: 1 page)The goal of this section should be to write a concise but adequate explanation of the aims of the proposal. You will be assessed on whether the objectives are realistic and can be achieved over the time period of the research project.Express the research question in the form of a hypothesis or any appropriate alternative that captures the central problem addressed by the research. This section should include the originality, insight, rigour and national or international significance of the research question.•Describe the relation between the research question and the background research literature. Clearly outline how new directions and ideas will extend or advance current knowledge in this area.•Explain the objectives of the research and justify them.•Describe the steps you have taken or will take to consult with M?ori in either this Section, Section 2, or both, whichever is most appropriate to your project.SECTION 2: RESEARCH DESIGN AND METHODS (Limit: 2 pages)Explain the methods for conducting the research and why they are appropriate.Include a timeline of key events.Include a discussion on statistics and describe how the statistical analysis is to be carried out.SECTION 3: STRATEGIC IMPORTANCEDescribe the benefits from your research to New Zealand.SECTION 4: EXPECTED OUTCOMES (Limit: 1/2 page)Note: Scientific outcomes should be covered in the previous sections.Describe the expected outputs from the research such as publications, conference presentations, industry or government support/engagement and how these what potential impact this will have on health.


Section 1

Depression, commonly known as major depressive disorder are characterised by persistent low mood that is manifested by the affected individual in most situations. This condition is generally accompanies by loss of interest, low self-esteem, pain, and low energy (Snyder, 2013). This psychological condition most often creates negative impacts on the personal, and professional life of the affected person and also affects the eating and sleeping habits, thereby lowering the general health status.
Research hypothesis
Cognitive behavioural therapy is more effective than antidepressants in the treatment of major depressive disorder
Cognitive therapy is directed towards solving presenting mental problems of clients and also teach the clients to bring about modifications in their behaviour and dysfunctional thinking (van der Velden et al., 2015). On the other hand, antidepressants are drugs used for the treatment of depression and other comorbid conditions such as, anxiety disorders, dysthymia, and seasonal affective disorder (McGrath et al., 2013). Selective serotonin reuptake inhibitors are the mainstay of treating depression owing to their mild side effects and less toxicity, when administered in overdose, in comparison to other antidepressants (Cipriani et al., 2016). On the other hand, studies have also shown that cognitive therapy effectively treats depression and its effectiveness is comparable to that of psychodynamic therapy and antidepressants (Hollon et al., 2014).
Research objectives

To determine the effectiveness of antidepressant (fluoxetine) on reducing depression associated mood and behaviour- Antidepressants have been identified as best pharmacotherapy options for treating people with a history of moderate to severe depression
To determine the effectiveness of cognitive therapy on lowering symptoms associated with depression- It has been recommended for patients suffering from moderate to chronic unipolar depression
To compare between the two interventions and identify the better treatment option- Comparing between the two options will pave the way for new clinical applications and improve patient outcomes

Section 2
Participant selection
Eligibility criteria will include participants, aged 18 years or more, who have been diagnosed with mild depression, based on the DSM-V diagnostic criteria (Uher et al., 2014). A total of 200 participants will be recruited over a period of six months. The inclusion criteria will comprise of individuals who will score more than 18 in the Montgomery–Åsberg Depression Rating Scale (MADRS) (Kjærgaard et al., 2014). They should be of normal intelligence and in good health. However, patients who are on fluoxetine or cognitive therapy treatment will be excluded from the study. Exclusion criteria will include those with a concurrent diagnosis of bipolar disorder, known systemic medical disorder, and clinical diagnosis of any substance use disorder.
Sample recruitment
Private psychiatrists, general practitioners and local psychiatric inpatient units will be contacted for recruitment. Pamphlets will also be distributed in university campuses, waiting rooms and community centres.
Ethical approval
Approval to conduct the RCT will be collected from the Human Research Ethics Committee. Following participant selection, an envelope will be sent to all of them, stating the purpose, benefits and use of the research. This will be followed by obtaining a written informed consent from each of them.
Individuals who will qualify for the research will be randomly assigned to one of the two study conditions, namely, cognitive therapy and antidepressant pharmacotherapy. This will be done after matching every subject in one particular group with the counterpart in the other. This will reduce chance of skewing results due to some influential variable. Randomisation process will be conducted by research staff, blinded to the treatment condition, until the end of the study. All therapists will provide the treatment in both the intervention groups. Patients assigned to the antidepressant treatment group will be made to attend one week long sessions with a trained psychiatrist.
All participants will be examined at the beginning of the study, at 6 weeks, and 12 weeks. The medication sessions will have a duration of 30-60 minutes and will also include a vital signs assessment and measurement of the adverse effects of drugs, their safety dosage, and symptomatic response. This will occur weekly, for the first month, and every alternate week thereafter. The dosage of the SSRI (fluoxetine) will be 10mg/day for the first week, followed by 20mg/day for weeks 2 to 6. There will be an option to increase the dosage to 40mg/day on observing insufficient clinical improvements among the patients, based on the Clinical Global Impressions-Severity subscale. The maximum dosage of fluoxetine that will be allowed. Following any adverse effects after increase in dosage of the medication, it will be lowered to 20mg of fluoxetine.
During the follow-up period, fluoxetine administration will continue. However, there will be face-to-face meetings. Booster sessions will be held that will focus on clinical management. The treatment will be focused on the following: (1) pharmacotherapy management that will involve providing education to the patients about the medication, dosage adjustment and schedules and potential side effects, (2) clinical management that will involve assessing the functioning of the participants in major life activities, limited advice giving and support counselling.
Cognitive Behavioural Therapy
The CBT will comprise of behavioural activation and modification of dysfunctional thoughts, in addition to incorporating structural modification and identification of core beliefs that are presumed to result in depressive thoughts in the participants. This therapy will comprise of 12 sessions, each for a duration of 60-90 minutes during the first 12 weeks of the intervention. Of these, weeks 3-6 will comprise of family sessions, which will be aimed at identifying the roots of major depressive disorder among the participants. The family session will also assist all family members to behave and think more adaptively, thereby allowing the family members to demonstrate respect, empathy, and care towards the affected individuals.
The treatment will be administered in a progressive manner that will facilitate the recognition and modification of core and intermediate beliefs. While the first week sessions would focus on establishing a rapport, reviewing the problem, and providing a general outline for the therapy, the following weeks will encompass relaxation training, problem solving, personalisation, fallacy control and overgeneralisation.
Primary outcome
Presence of depressive symptoms and suicidal ideations will be the primary outcomes based on the Hamilton Rating Scale for Depression and Suicide Ideation Questionnaire-Jr. Self-reported depression will also be measured by the Beck Depression Inventory II scale.
Secondary outcome
Assessing the functional status of the participants will be the secondary outcome.
Statistical analysis
All primary analyses will be based on a 2*2 balanced factorial design that will depend on an intention-to-treat format. SPSS 21.0 software will be used for statistical evaluation of the outcomes (Dimaggio, 2013). The differences in participant responses will be calculated using logistic regression and χ2, which will help in testing the effects of the medication and CBT. A random effects linear regression will be conducted to determine the effects of both the treatment on the symptom trajectory. Furthermore, ANOVA will be used to measure pre-treatment group differences (Campbell &Lele, 2014)
                                                     Table 1- Timeline showing the proposed research
Section 3
Strategic importance
Owing to fact that one in six adults had been diagnosed with common mental disorders at a point in their lives by the 2012/13 New Zealand Health Survey, there is a need to effectively disseminate the findings of the RCT (Mental Health Foundation, 2018). Following an analysis of the outcomes, the study will help in gaining a sound understanding of the better intervention for treating depression, the evidence of which can be utilised by clinicians and therapists for reducing the prevalence rates of the disorder in New Zealand.
Section 4
Expected outcomes that focus on a greater reduction in depression and suicidal thoughts upon CBT administration will be disseminated by presenting an article and sending it for publication in an international journal. Conference presentations will be held with the key stakeholders such as, public health officials, patients, healthcare providers, research committees, and health organisations. An effective presentation of the findings might be successful in gaining government funding for future research.
Campbell, D., &Lele, S. (2014). An ANOVA test for parameter estimability using data cloning with application to statistical inference for dynamic systems. Computational Statistics & Data Analysis, 70, 257-267.
Cipriani, A., Zhou, X., Del Giovane, C., Hetrick, S. E., Qin, B., Whittington, C., …&Cuijpers, P. (2016). Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. The Lancet, 388(10047), 881-890.
Dimaggio, C. (2013). Introduction. In SAS for Epidemiologists(pp. 1-5). Springer, New York, NY.
Hollon, S. D., DeRubeis, R. J., Fawcett, J., Amsterdam, J. D., Shelton, R. C., Zajecka, J., … & Gallop, R. (2014). Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. JAMA psychiatry, 71(10), 1157-1164.
Kjærgaard, M., Arfwedson Wang, C. E., Waterloo, K., &Jorde, R. (2014). A study of the psychometric properties of the Beck Depression Inventory?II, the Montgomery and Åsberg Depression Rating Scale, and the Hospital Anxiety and Depression Scale in a sample from a healthy population. Scandinavian journal of psychology, 55(1), 83-89.
McGrath, C. L., Kelley, M. E., Holtzheimer, P. E., Dunlop, B. W., Craighead, W. E., Franco, A. R., … &Mayberg, H. S. (2013). Toward a neuroimaging treatment selection biomarker for major depressive disorder. JAMA psychiatry, 70(8), 821-829.
Mental Health Foundation. (2018). Quick Facts and Stats 2014. Retrieved from https://www.mentalhealth.org.nz/assets/Uploads/MHF-Quick-facts-and-stats-FINAL.pdf
Snyder, H. R. (2013). Major depressive disorder is associated with broad impairments on neuropsychological measures of executive function: a meta-analysis and review. Psychological bulletin, 139(1), 81.
Uher, R., Payne, J. L., Pavlova, B., & Perlis, R. H. (2014). Major depressive disorder in DSM?5: Implications for clinical practice and research of changes from DSM?IV. Depression and anxiety, 31(6), 459-471.
van der Velden, A. M., Kuyken, W., Wattar, U., Crane, C., Pallesen, K. J., Dahlgaard, J., … & Piet, J. (2015). A systematic review of mechanisms of change in mindfulness-based cognitive therapy in the treatment of recurrent major depressive disorder. Clinical psychology review, 37, 26-39.

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