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92612 Research In Health 4

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92612 Research In Health 4

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92612 Research In Health 4

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Course Code: 92612
University: University Of Technology Sydney is not sponsored or endorsed by this college or university

Country: Australia

Topic: In Patients With Depressive Disorder Are Supplementary Cognitive Behaviour Therapy More Effective Than Pharmacotherapy Alone?

Development of a draft research proposal 

Clarity of Title and Introduction
Focus and clarity of Background
Clarity of Study Aim
Clarity, accuracy and justification for proposed draft Methods
Description and justification of proposed Design
Beginning description of sample, data collection approaches


Depressive disorder is a mental health condition associated with persistent feelings of low mood, loss of interest in activities, sadness and reduced interest in daily life activities. Pharmacotherapy is one of the first line of treatment for depression. However, use of anti depressive treatment is associated with many challenges for clinicians because of controversies related to efficacy of many anti hypertensive drugs (Popa-Velea et al. 2015). In case of elderly people, depression is associated with many overlapping symptoms because of co-morbid illness. Hence, aging related changes in pharmacokinetics and pharmacodynamics also brings unique challenges in treatment because of the need to adjust dosing and monitoring requirements for patient after initiation of pharmacological treatment (Rojas-Fernandez and Mikhail 2012). Current evidence suggests use of cognitive behavioural therapy as an effective treatment option for patients who do not respond to pharmacotherapy. It is a skill based intervention that teaches patient to manage their mood and achieve long term benefit even after discontinuation of therapy (Nielsen 2015). However, the cost effectiveness of CBT has not been established because of problems related to methodological limitation in past studies conducted regarding the efficacy of the strategy. In response to these inconsistencies in research outcome, the main purpose of this research proposal is to determine whether supplementary CBT is more effective than pharmacotherapy alone for treatment of depression. The research proposal looks at past research done on the topic to find answers that are yet to be answered and develops appropriate research methodology to gain answer to the research question.
The review of research literature reveals several gap in research literature related to the effectiveness of supplementary CBT as a treatment option for people with depression in comparison to pharmacotherapy. Wiles et al. (2016) argues that CBT has not been widely implemented as a treatment option for people with depression despite advancement of psychological service because it is limited only for those people who do not respond well to anti depressive medications. Wiles et al. (2016) investigated about the cost effectiveness of CBT compared to usual treatment in addressing depressive symptoms and improving quality of life. By the use of randomized controlled trial, the study revealed CBT as a useful replacement compared to usual care for treatment of patients with long term depression. The study also revealed effectiveness of CBT in preventing remission of symptoms in the future. The significance of the study was that it evaluated long term effectiveness of the therapy too. However, one limitation of the research design was collection of long term follow up data using postal questionnaire instead of face to face questionnaire which limited the validity of long term clinical outcomes. Direct interview and survey with patient might have helped to gain more knowledge related to the barriers faced in using CBT as a treatment choices. The mode of implementation of the therapy also needs to be considered as Mohr et al. (2012) revealed that providing CBT over the telephone or face-to-face interaction provides equivalent improvement in depression. However, in case of telephone based CBT, treatment adherence comes at the cost poor maintenance after treatment cessation.
Research has also been done on smart phone CBT as an alternative treatment option for depression. Mantani et al. (2017) conducted such study because of ineffectiveness of antidepressants as a treatment option for patients with depression. By the use of randomized controlled trial method, the study used an app to implement CBT and encourage participants to switch to the app in the smart phone. The control group received only antidepressant treatment and the intervention group received both anti-depressant switch and smart phone CBT. The review of sessions attended using smart phone CBT and session completed through the intervention revealed CBT smart phone as an effective intervention for people who do not respond well to antidepressants. The intervention was also found to reduce overall burden of side effect of pharmacotherapy. However, one issue that was found was that relapse prevention could not take place even after 2 months of therapy. Hence, working on the effectiveness of CBT in wider clinical context is important. The issue of relapse of symptom after treatment for depression has been highlighted by Cruwys et al. (2013) as it limits the effectiveness of depression treatment for long-term period.
A systematic review method explored the efficacy of pharmacotherapy and psychotherapy for patients with psychiatric disorders like depression. As there is great controversy regarding the use of psychotherapy or medication for treatment of depression, Huhn et al. (2014) conducted a systematic review of meta-analysis to determine the efficacy of drug therapy and psychotherapy for depression. The researcher used different criteria to evaluate efficacy of both the therapy. For example, classes of drug were considered instead of single drugs, CBT and psychodynamic approach was considered and most up-to-date evidence was reviewed. The overall analysis of systematic review suggested that combination of both pharmacotherapy and psychotherapy is superior to single intervention. Methodological differences in the treatment also determined larger effect size of the intervention. Hence, methodological differences in pharmacotherapy and psychotherapy limited the scope of direct comparison between outcomes. Hence, in the future, there is a need for robust study design so that both treatment choices can be compared and the factors contributing to efficacy of combined treatment can be established. There is also a need to identify factors that improve the delivery and skills of mental health care professionals in the delivery of CBT for depression (Ngo et al. 2011).
Tolin (2017) also evaluated the efficacy of combination treatment such as CBT and pharmacotherapy for treatment of anxiety and depression. This article directly investigated the question whether pharmacology can be combined with CBT to improve outcomes for depressive patients compared to CBT alone. By conducting a meta-analysis of research studies, the study revealed little evidence to support the effectiveness of combining antidepressant medication along with CBT as an effective first line treatment option for people with depression. Many limitations were found in research studies such as lack of consideration of side-effects of drug which limited the credibility of the work. In contrast to this, a randomized controlled trial by Nakagawa et al. (2014) evaluated the effectiveness of supplementary CBT for pharmacotherapy resistant depression. The study was conducted in one university hospital and on psychiatric hospital with a 12 months follow-up period. The participants were randomly assigned to treatment as usual CBT combined with treatment as usual group. The GRID Hamilton Depression Rating Scale was used to measure primary outcome of alleviation of depressive symptom in patient. The study yielded positive treatment outcome as supplementary CBT was found superior to control group intervention in alleviating depressive symptoms. Positive long-term outcome was also obtained following 12 months of follow-up. However, certain limitations in the paper such sampling biased affected the generalisabiity of research outcomes. Hence, few past studies established the efficacy of supplementary CBT therapy however certain inconsistencies and limitations in research design influenced the transferability of the work. This proposal aims to overcome those differences by the selection of appropriate research design to conduct the research.
The main aim of the research proposal is to gain answer to the following research question:
‘In patients with depressive disorder, is supplementary cognitive behaviour therapy more effective than pharmacotherapy alone?’
Research method:
To gain answer to the research question, it is planned to conduct a randomized controlled study to evaluate outcomes related to changes in depressive symptoms, prevention of relapse and identify of barriers in the use of treatment by patients. Randomized controlled trial method has been chosen as the research design as it is suitable to test a new treatment or intervention for target group of people. Another advantage of randomized controlled trial method is that it limits the possibility of internal bias like selection bias because of the comparison of baseline data of intervention and control group (Frieden 2017). Although past research has also used randomized controlled method to investigate about the effectiveness of supplementary CBT, however this research aims to improve research outcome by taking additional measures like taking rigorous methods to include participants into the research study and inclusion of additional outcome variables to assess the outcome of treatment.
The participants for the research will be randomly allocated to intervention and control group. The control group will receive pharmacotherapy alone and the intervention group will receive face to face CBT delivered within 3 months period. The intervention group will mainly receive pharmacotherapy along with CBT training. The CBT session will cover training on behavioural activation, social support, relaxation training, assertiveness training, coping and anger management and cognitive restructuring of patients. The outcome assessment will focus on evaluating impact of intervention on depressive symptoms, relapse prevention and identifying barriers and facilitators to treatment too.
The sample group for the research will include patients with major depressive disorder order admitted to psychiatric hospital or mental health clinics. The criteria for inclusion of participants in research will include use of the DSM-V criteria to identify patients with major depressive disorder. The use of DSM-V criteria is considered effective as it may help included research participants with similar level of severity. The DSM-V criteria also provide the standard language by which clinicians and researchers can identify types of mental disorders in changes. The DSM-V criteria are also recently published with changes and it offers explicit diagnostic criteria to define and identify types of mental disorder in patient (Regier, Kuhl and Kupfer 2013). Ethical approval for research will be taken by the Research Ethics Committee and the hospital’s authority before taking informed consent from research participants. The final selection of sample will be done after the participants give consent for research.
Data collection:
It is planned to collect data related to outcome before the study and three months after the implementation of the intervention. The primary outcome variable of interest will be decrease in depressive symptoms. This will be evaluated by the use of Beck Depression Inventory II tool as it is a validated evidence based tool that has been found to have high reliability and correlation in the context of measuring depression and anxiety. It can also be easily adopted in any clinical setting (Wang and Gorenstein 2013). The secondary outcome measure will include assessment of symptom relapse and barriers and facilitators to treatment. Data related to secondary outcome will be collected by conducting face-to-face interview with research participants following 3 months of the intervention. This method will help to evaluate the efficacy of the intervention in terms of reduction in depressive symptoms, acceptance of treatment and symptom relapse status.
Cruwys, T., Dingle, G.A., Haslam, C., Haslam, S.A., Jetten, J. and Morton, T.A., 2013. Social group memberships protect against future depression, alleviate depression symptoms and prevent depression relapse. Social Science & Medicine, 98, pp.179-186.
Frieden, T.R., 2017. Evidence for health decision making—beyond randomized, controlled trials. New England Journal of Medicine, 377(5), pp.465-475.
Huhn, M., Tardy, M., Spineli, L.M., Kissling, W., Förstl, H., Pitschel-Walz, G., Leucht, C., Samara, M., Dold, M., Davis, J.M. and Leucht, S., 2014. Efficacy of pharmacotherapy and psychotherapy for adult psychiatric disorders: a systematic overview of meta-analyses. JAMA psychiatry, 71(6), pp.706-715.
Mantani, A., Kato, T., Furukawa, T.A., Horikoshi, M., Imai, H., Hiroe, T., Chino, B., Funayama, T., Yonemoto, N., Zhou, Q. and Kawanishi, N., 2017. Smartphone cognitive behavioral therapy as an adjunct to pharmacotherapy for refractory depression: randomized controlled trial. Journal of medical Internet research, 19(11).
Mohr, D.C., Ho, J., Duffecy, J., Reifler, D., Sokol, L., Burns, M.N., Jin, L. and Siddique, J., 2012. Effect of telephone-administered vs face-to-face cognitive behavioral therapy on adherence to therapy and depression outcomes among primary care patients: a randomized trial. Jama, 307(21), pp.2278-2285.
Nakagawa, A., Mitsuda, D., Sado, M., Abe, T., Fujisawa, D., Kikuchi, T., … & Ono, Y. (2017). Effectiveness of Supplementary Cognitive-Behavioral Therapy for Pharmacotherapy-Resistant Depression: A Randomized Controlled Trial. The Journal of clinical psychiatry, 78(8), 1126-1135.
Ngo, V.K., Centanni, A., Wong, E., Wennerstrom, A. and Miranda, J., 2011. Building capacity for cognitive behavioral therapy delivery for depression in disaster impacted contexts. Ethnicity & disease, 21(3 0 1), p.S1.
Nielsen, M., 2015. CBT group treatment for depression. the Cognitive Behaviour Therapist, 8.
Popa-Velea, O., Gheorghe, I.R., Tru?escu, C.I. and Purc?rea, V.L., 2015. Current challenges and pitfalls in the pharmacological treatment of depression. Journal of medicine and life, 8(2), p.181.
Regier, D.A., Kuhl, E.A. and Kupfer, D.J., 2013. The DSM?5: Classification and criteria changes. World Psychiatry, 12(2), pp.92-98.
Rojas-Fernandez, C. and Mikhail, M., 2012. Contemporary concepts in the pharmacotherapy of depression in older people. Canadian Pharmacists Journal/Revue des Pharmaciens du Canada, 145(3), pp.128-135.
Tolin, D.F., 2017. Can Cognitive-Behavioral Therapy for Anxiety and Depression Be Improved with Pharmacotherapy? A Meta-Analysis. Psychiatric Clinics of North America.
Wang, Y.P. and Gorenstein, C., 2013. Assessment of depression in medical patients: a systematic review of the utility of the Beck Depression Inventory-II. Clinics, 68(9), pp.1274-1287.
Wiles, N.J., Thomas, L., Turner, N., Garfield, K., Kounali, D., Campbell, J., Kessler, D., Kuyken, W., Lewis, G., Morrison, J. and Williams, C., 2016. Long-term effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: follow-up of the CoBalT randomised controlled trial. The Lancet Psychiatry, 3(2), pp.137-144.

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