Best Practice Regarding Clinical Trial Outcome Measures for Improvements for Bipolar Disorder

Abstract

The purpose of this research is to establish the best practice that can be used to help improve the conditions of patients with bipolar disorder. Individuals with the condition have higher death rates and lower life expectancies than other people, which can go up to 14 years less. Among the different interventions, the best one is cognitive behavioral therapy (CBT). It involves going through sessions that help an individual change the base problem, which is engagement in negative behaviors during the depressive and manic phases of the condition. CBT has advantages such as taking a shorter time than other techniques, having positive implications after one has gone through the process, and allowing an individual to have full control over themselves after the treatment. As much as it can be criticized, it remains the best option to manage bipolar conditions. 

Introduction

Bipolar disorder presents a risk for individuals who suffer from the condition. It is a chronic illness associated with high mortality rates that result from suicide and the acquisition of other additional diseases (Rowland & Marwaha, 2018, p. 251). This means that an individual with bipolar disorder is more likely to die from other illnesses than an individual without the disease. The main characteristic of bipolar disorder is recurrent episodes of depression and mania or hypomania (Nierenberg, Agustini, Köhler-Forsberg, Cusin, Katz, Sylvia et al., 2023, p. 1370). Depressive episodes are characterized by one feeling emotionally low and sad, and they lose interest in different issues of life. On the other hand, manic episodes are characterized by elevated moods where an individual feels energetic. Most times, bipolar disorder starts manifesting itself among individuals when they are between the ages of 15 and 25 and then persists throughout their lives.

As much as bipolar disorder is chronic, individuals can manage it or have it treated so that it does not result in serious implications. An example of such a severe implication among individuals is reduced life expectancy. Individuals with bipolar disorder have a reduced life expectancy of approximately 12 to 14 years (Nierenberg, Agustini, Köhler-Forsberg, Cusin, Katz, Sylvia et al., 2023, p. 1370). Hence, there should be enough interest in the topic to establish the ways in which it can be treated or managed. Whereas several ways to do this exist, questions arise on whether they are the best practices to undertake for patients with the condition. Therefore, this research answers the question: what is the best practice regarding clinical trial outcome measures that can be used to improve bipolar disorder among patients? The conclusion reached is that cognitive behavioral therapy (CBT) is the best practice.

Methods

Since the research is a literature review, the researcher knew that all sources needed to come from research done by other individuals. Still, it was necessary to focus on primary research since it gave firsthand information concerning the findings that other researchers have established. Furthermore, it was necessary to ensure that the sources of information come from reputable peer-reviewed sources. The introductory part and some parts of the discussion were exceptions in the sense that they did not necessarily require a reference to primary research. At those stages, the researcher undertook online research for academic sources that had written about bipolar disorder and used them to address the problem. 

For all other sources, the researcher used Google Scholar as the source of information to get electronic journals. Google Scholar has peer-reviewed journals that speak about different topics, and one can get them by undertaking a simple search of the keywords that relate to the topic they are searching about. Searching for the best practices concerning the practices that surround bipolar disorder was not sufficient. The researcher went ahead to look at the details of the documents selected to ensure that they met the desired criteria to be considered for the research. One of the requirements for the journal articles related to the time in which they were written. 

The researcher ensured that the articles were not written earlier than 2015. Over the years, certain information is bound to change. For example, new technology can help establish new ways of dealing with the bipolar condition. If this happens, old data concerning the ways that individuals would have dealt with bipolar disorder become irrelevant in society. For this reason, it was necessary to ensure that the research was between 2015 and the present. The other requirement that the researcher had for the papers was that they should have a digital object identifier (DOI). DOI ascertained that the source is reliable, which was one of the factors for consideration in this research. 

After looking for different journal articles that speak about bipolar disorder and the best practices involving the condition, the researcher examined what each article said about the proposals being made concerning the different practices. It was in compiling this information that the researcher wrote the discussion part of this paper. Comparison and contrast were done at two levels. The researcher first compared and contrasted different practices to determine the best practice. The second level of comparison and contrast was between different articles to cross-check and ascertain the information they shared. When it came to reporting the data, the researcher only said one practice that is best for dealing with bipolar disorder. All this is written in the discussion section of this paper. After conducting the research and analyzing the information from the different articles, the researcher established research gaps in the study and addressed them as questions. This was before giving the conclusion. 

Discussion

Bipolar Disorder

To better understand the best practice for dealing with bipolar disorder, it is necessary to have an in-depth look into the condition. Bipolar disorder remains a risk to people worldwide. In the United Kingdom (UK), data collected from the UK biobank proves that individuals with bipolar disorder were among the individuals with the highest risk of being hospitalized or dying during the coronavirus period (Hassan, Peek, Lovell, Carvalho, Solmi, Stubbs, et al., 2021, p. 1248). Other than being susceptible to external conditions that have negative implications on individuals with bipolar disorder, the changes in mood among individuals pose a threat to the people with the condition.

When individuals have manic and depressive episodes, they tend to possess self-destructive behavior. Depression brings about a loss in appetite, making an individual unhealthy. They lack the energy to continue their daily activities as they would under normal conditions, making them less productive in life. When one feels hopeless or depressed, they tend to make the wrong decisions concerning specific issues in life. For example, it is during such times that individuals are likely to attempt suicide because they do not see a reason for living. Whereas the suicide rate is 11 per 100,000 individuals per year, the suicide rate among individuals with bipolar disorder is 20 times more (Tondo, Vázquez, & Baldessarini, 2020, p. 14).

Manic episodes also present individuals with specific challenges. During such times, individuals become restless and anxious. When one has a lot of energy, they fail to get sufficient sleep as they remain insomniac. This has an influence on the quality of their life. Also, one easily gets irritated. In looking at the manic and depressive phases of bipolar disorder, it becomes evident that there are variations in a person’s behavior when they have the condition. Therefore, the best intervention would be one that addresses the behavior of the individual who is going through the condition, and the best practice is cognitive behavioral therapy (CBT)

Cognitive Behavioral Therapy (CBT)

CBT is a technique of addressing one’s condition by determining the contribution of one’s feelings, thoughts, and behaviors to the current problem that one has. The practice has been effective in helping patients with conditions that relate to anxiety (Kaczkurkin & Foa, 2015, p. 337). Compared to other interventions, CBT has proven to have the best results (Ong, Hayes, and Hofmann, 2022). The process involves an individual discussing specific problems with their therapist and setting certain goals. By working towards achieving these goals, the affected individuals will be working to overcome the behavioral problems that they have concerning their condition.

An example of such is when an individual who has been trying to commit suicide as a result of bipolar disorder sets a goal to celebrate life during certain times of the month. Every time that they celebrate life, they will appreciate the fact that they are not dead, and this will help them overcome suicidal thoughts over time. The therapist decides on the best approach to take depending on the patient’s willingness and the available resources. For example, the integrated primary care model for promoting CBT works well only when the patient is willing to have this model and there are sufficient facilitators to provide the required labor for this (Shepardson, Fletcher, Funderburk, Weisberg, Beehler, and Maisto p. 709). Different reasons make CBT the best practice for dealing with bipolar disorder.

Reasons CBT is the Best Practice to Deal with Bipolar Disorder 

One of the advantages of CBT over other techniques of treatment is that CBT presents individuals with a shorter recovery time. Figure one gives an illustration of the time taken when individuals applied CBT in comparison to treatment as usual (TAU) (Scott, Bentall, Kinderman, and Morriss, 2022, p. 5). Quicker recovery from a condition is essential because it saves the body from going through the stress that the condition would continue to put on an individual. 

Survival curve showing the time it takes to recover from depressive episodes when CBT and TAU are applied to different patient

Figure 1: Survival curve showing the time it takes to recover from depressive episodes when CBT and TAU are applied to different patients

The other reason why CBT is more effective than other treatment techniques is that it has long-term effects. When an individual implements this strategy and changes their behavior, they continue reaping the benefits of this technique. However, other techniques promote reliance, which proves to be negative among individuals. A study conducted on 34 patients with bipolar disorder proves this fact. Before the intervention of CBT, 97 percent of the individuals were using sleep medication because they could not get sufficient sleep (Jernelöv, Killgren, Ledin, and Kaldo, 2022, p. 1). On the other hand, 91 percent of the individuals used medication for their primary condition. When they employed CBT, there was a change, and they stopped depending on the different forms of medication. Therefore, CBT helps avoid overreliance on medication by providing a long-term solution for individuals. 

The other advantage that CBT has over other treatment techniques is that it gives patients the ability to be in control of themselves. CBT addresses the issue at its base, which is individual behaviors, by making them change and adopt positive ones. For an alternative intervention such as medication, an individual will always need to have the specific medicine that stabilizes their mood for them to be okay. Furthermore, it can have negative implications, such as allergies. However, CBT brings about a change in which one is fully in control of what they do. After identifying issues that trigger their depressive and manic phases, individuals can easily avoid them through behavioral practices. Therefore, CBT is an excellent way of promoting conscious decisions that help individuals with bipolar disorder.

An Argument Against CBT In Comparison to Other Practices

As much as CBT is positive, it has received some criticism. A common criticism of CBT is that it does not work unless an individual is willing to commit to the process and follow through with every step of what it requires. As a result of this analogy, individuals have developed a different form of therapy referred to as Acceptance and Commitment Therapy (ACT). In ACT, individuals first accept that the behaviors they have are a part of their lives. They then do their best to live in environments that promote positive behavior. Combining ACT with CBT has proven to be effective (Witlox, Kraaij, Garnefski, Bohlmeijer, Smit, and Spinhoven, 2022, p. 1). However, having individuals accept their condition might demotivate them to act to change. Therefore, CBT still stands as an effective technique to help individuals with bipolar disorder. 

Outstanding Questions

  • What is the step-by-step guidance that one needs to conduct CBT on an individual?
  • If a person’s bipolar condition is extreme, will CBT start working immediately, or is it necessary to combine it with a different technique to help the patient?
  • Since CBT addresses the base of the problem, which is individuals’ behaviors, what can be done to address the root cause?
  • What are the relapse rates for individuals who have undergone CBT as a treatment method?
  • What are the CBT options for individuals who cannot afford professional interventions because of cost implications?

Conclusion

Bipolar condition is a challenging situation among individuals because of the negative implications it has. Individuals with this condition are more likely than other individuals to die from additional illnesses. They are also likely to engage in negative behavior that can harm them. The condition is characterized by depressive and manic episodes, where individuals have low moods and then they feel energetic. It also reduces life expectancy by between 12 and 14 years. The method of literature review for this study involved searching peer-reviewed electronic journals. Each source needed to have a digital object identifier. The researcher still went ahead and looked at the content of each article to ensure that it matched the requirements of the assignment. From the different articles, the researcher noted that CBT is the most advantageous technique for dealing with bipolar disorder. It takes a shorter time compared to other techniques, has no negative effect after the treatment period, and allows one to stay in control of their behavior. Despite the criticism it receives, it remains the best practice. Future areas of research include the steps that can be taken to conduct CBT, the need to identify whether CBT needs to be done in combination with other treatment techniques, what can be done to address the root cause of the problem, the relapse rates, and CBT options for individuals on a low budget. 

References

Hassan, L., Peek, N., Lovell, K., Carvalho, A. F., Solmi, M., Stubbs, B., & Firth, J. (2021). Disparities in covid-19 infection, hospitalization and death in people with schizophrenia, bipolar disorder, and major depressive disorder: A cohort study of the UK Biobank. Molecular Psychiatry27(2), 1248–1255. https://doi.org/10.1038/s41380-021-01344-2

Jernelöv, S., Killgren, J., Ledin, L., & Kaldo, V. (2022). Treatment feasibility and preliminary evaluation of group-delivered cognitive behavioral therapy for insomnia adapted for patients with bipolar and related disorders: A pragmatic within-group study. Journal of Affective Disorders Reports7. https://doi.org/10.1016/j.jadr.2021.100293

Kaczkurkin, A. N., & Foa, E. B. (2015). Cognitive-behavioral therapy for anxiety disorders: An update on the empirical evidence. Dialogues in Clinical Neuroscience17(3), 337–346. https://doi.org/10.31887/dcns.2015.17.3/akaczkurkin

Nierenberg, A. A., Agustini, B., Köhler-Forsberg, O., Cusin, C., Katz, D., Sylvia, L. G., Peters, A., & Berk, M. (2023). Diagnosis and treatment of bipolar disorder. JAMA330(14), 1370–1380. https://doi.org/10.1001/jama.2023.18588

Ong, C. W., Hayes, S. C., & Hofmann, S. G. (2022). A process-based approach to cognitive behavioral therapy: A theory-based case illustration. Frontiers in Psychology13. https://doi.org/10.3389/fpsyg.2022.1002849

Rowland, T. A., & Marwaha, S. (2018). Epidemiology and risk factors for bipolar disorder. Therapeutic Advances in Psychopharmacology8(9), 251–269. https://doi.org/10.1177/2045125318769235

Scott, J., Bentall, R., Kinderman, P., & Morriss, R. (2022). Is cognitive behaviour therapy applicable to individuals diagnosed with bipolar depression or suboptimal mood stabilizer treatment: A secondary analysis of a large pragmatic effectiveness trial. International Journal of Bipolar Disorders10(1), 1–9. https://doi.org/10.1186/s40345-022-00259-3

Shepardson, R. L., Fletcher, T. L., Funderburk, J. S., Weisberg, R. B., Beehler, G. P., & Maisto, S. A. (2023). Barriers to and facilitators of using evidence-based, cognitive–behavioral anxiety interventions in integrated primary care practice. Psychological Services20(4), 709–722. https://doi.org/10.1037/ser0000696

Tondo, L., Vázquez, G. H., & Baldessarini, R. J. (2020). Prevention of suicidal behavior in bipolar disorder. Bipolar Disorders23(1), 14–23. https://doi.org/10.1111/bdi.13017

Witlox, M., Kraaij, V., Garnefski, N., Bohlmeijer, E., Smit, F., & Spinhoven, P. (2022). Cost-effectiveness and cost-utility of an acceptance and commitment therapy intervention vs. A cognitive behavioral therapy intervention for older adults with anxiety symptoms: A randomized controlled trial. PLOS ONE17(1), 1–20. https://doi.org/10.1371/journal.pone.0262220

Author: Will Richardson
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