DRAFT PROSPECTUS FOR DNP DIRECT PRACTICE IMPROVEMENT PROJECT .ON HOW PHYSICAL ACTIVITIES AND EXCERCISE REDUCE GENERALIZED ANXIETY DISORDER XERCISE

DNP Learner Name________Numu Kamara_____________________________ Current Course : DNP
Submit the Completed Template *See Additional Instructions below for completing the Template on Page 2.
PICOT-D Question Template
P Population Adults aged between 30 and 55 years with generalized anxiety disorder
I Intervention Exercise and physical activity
C Comparison Medication treatment
O Outcome Reduce anxiety score
T Timeline 3 months
D Data Generalized Anxiety Disorder 7-item scale (GAD-7)
What is your licensure? APRN RN

Is this practice change within the scope of your nursing practice?
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By submitting this form, I am attesting I have read my state’s Nurse Practice Act, and the project is within the scope of my practice.
PICOT
In adults aged between 30 and 55 years with a generalized anxiety disorder (GAD) [P], how do exercise and physical activity [I] compared to medication treatment alone [C] reduce anxiety score [O] within four weeks [T]?
Problem Statement
Research conducted by Locke, Kirst, and Shultz (2015) shows that one of the most common mental disorders in America is generalized anxiety disorder (GAD). The researchers also indicate that it contributes to poor quality of life for people with GAD since it disrupts their daily routines and how they conduct activities of daily living (ADLs) (Locke, Kirst, and Shultz, 2015). A study conducted by Herring, Johnson, and O’Connor (2016) shows that exercise and physical activities are effective when it comes to managing generalized anxiety disorder (GAD). However, a study by Stavestrand, Sirevåg, Nordhus, Sjøbø, Endal, Nordahl, and Andersson (2019) shows that some people dealing with generalized anxiety disorder prefer to use medication to manage the situation such as anxiolytics and or cognitive behavioral therapy (CBT). Nevertheless, the researchers also show that medication when it comes to generalized anxiety disorder is not recommended since it leads to issues such as polypharmacy and addiction (Stavestrand et al., 2019). As such, exercise and physical activities are recommended in regards to managing generalized anxiety disorder. With increased cases of a generalized anxiety disorder (GAD) in the United States, it is important to come up with a viable intervention that will help reduce these cases and help people manage their anxiety.

Purpose Statement The purpose of this study is to determine how exercise and physical activities can be effective in managing generalized anxiety disorder (GAD) compared to the use of medication for adults aged between 30 and 55 years. The exercise will take place for a course of three months, where adults aged between 30 and 55 years with a generalized anxiety disorder will participate in a study that will include both the use of medication and applying exercise and physical activities. The generalized Anxiety Disorder 7-item scale (GAD-7) tool will be used to measure GAD for all patients at the beginning of the study and after the study. This will help to determine if the rationale of the study was achieved and if exercise and physical activities were effective in reducing the anxiety score compared to the use of medicine.

Original Research articles:
List all original research articles that support the intervention (Required)
Herring, M. P., Johnson, K. E., & O’Connor, P. J. (2016). Exercise training and health-related quality of life in generalized anxiety disorder. Psychology of Sport and Exercise, 27, 138- 141.
Locke, A., Kirst, N., & Shultz, C. G. (2015). Diagnosis and management of generalized anxiety disorder and panic disorder in adults. American family physician, 91(9), 617-624.
Stavestrand, S. H., Sirevåg, K., Nordhus, I. H., Sjøbø, T., Endal, T. B., Nordahl, H. M., … & Andersson, E. (2019). Physical exercise augmented cognitive behavior therapy for older adults with a generalized anxiety disorder (PEXACOG): study protocol for a randomized controlled trial. Trials, 20(1), 1-14.

Anxiety Article Summary

Numu Kamara
Grand Canyon University
DNP 830
Dr.Amy Salgado
11/10/2021

Introduction
The essay is based on a critical examination of the use of quantitative, qualitative, and mixed methodologies approaches in research investigations, as well as their limitations. The sorts of studies utilized in different statistical tests, research publications, and the development of non-parametric and parametric analysis, as well as the reliability and validity of the studies, will all be discussed in the analysis. The proper selection of the research strategy is very important since it has a direct influence on the data produced and the conclusions drawn as a consequence of those results.
Types of Studies Used in the Articles
Aylett, Small, and Bower, (2018) carried out a systematic review with the purpose of comparing the effectiveness of exercise to the waiting list control groups in anxiety treatment. More so, the research determines if high-intensity exercise is superior to low-intensity exercise. The researchers found out that exercise programs might be an effective therapeutic option for those suffering from anxiety disorders. Exercise regimens with a high level of intensity were shown to be more efficient than exercise regimens with a low level of intensity. There are ramifications for the implementation of exercise regimens in general practice based on the findings.
The second article by Li, Liu, Wang, and Smith (2020) has the purpose of conducting a comprehensive analysis of the impact of mind-body exercise on COPD patients suffering from anxiety and depression, as well as giving scientific evidence-based exercise recommendations. Finally, suitable randomized controlled trials (RCTs) were included in the meta-analysis. Exercise that incorporates both the mind and the body may help people with COPD feel less anxious and depressed.
Edwards, Walsh, Diment, and Roberts (2018) carried out research using skin sensitization with Diphenylcyclopropenone with the aim of investigating the relationship between perceived psychological stress and anxiety indicated before exercise as well as in vivo immunity after exercise (DPCP). The research revealed that when it comes to influencing the intensity of the in vivo immune response following perceived psychological stress, exercise, and state-anxiety levels are crucial factors to consider. It seems that, as previously documented, the amount of state anxiety experienced before exercise, as well as the level of physiological stress experienced during exercise, both have a comparably high connection with the in vivo immune response after exercise.
The type of statistical test used in each article
In Li, Liu, Wang, and Smith (2020) research, the statistical analysis of the research results was carried out in accordance with the Cochrane Handbook and was carried out using the software program Revman 5.3, which analyzed post-test scores from both the intervention and control groups in each study. Such tactics are based on the assumption that baseline scores on the main outcome are equal. Because all participants were randomly assigned, any differences in baseline scores across trials would be limited. However, baseline imbalance is possible, especially when the number of patients engaged is small. Alternate methods of analysis include the use of gain scores, in which the difference between the results of each research study is pooled together to establish the overall amount of the impact. However, there is no compelling evidence to suggest that one approach is superior to the other, and the use of gain scores may require the inclusion of additional assumptions when data on change is not provided in the study.
Edwards et al. (2018) used hierarchical linear regression to investigate the relationship between STAI-S and PSS (in two distinct models) and in vivo immunity after exercise. More in-depth analysis may be carried out by classifying the population according to STAI-S scores and dividing that population by the median of the scores. Independent t-tests were used to compare the cumulative cutaneous responses to DPCP in LOW and MOD in each group, with the findings showing that the results were statistically significant in both groups. The results of a one-way ANOVA were utilized to compare psychological measures across the groups (30MI, 30HI, 120MI, and CON), and the findings were investigated further. Two-way mixed model ANOVA was used to examine DPCP responses throughout the whole dosage-series challenge (anxiety level x dose), and circulating stress hormones (anxiety level x time) were analyzed using a post hoc Tukey HSD test where necessary. The statistical analyses were carried out with the use of readily accessible statistical software toolsets. It is reported in terms of Cohen’s d effect sizes (d) to illustrate the importance of group differences in DPCP answers; values more than or equal to 0.20, 0.52, and 0.8 denote small effect, medium impact, and big effect. DPCP responses are compared across groups using Cohen’s d effect sizes, which show the importance of group differences in DPCP answers.
It was determined that the results of the investigation were statistically significant when they were analyzed statistically using the approach outlined in the Cochrane Handbook as well as executed in the software application Revman 5.3, which also included trying to compare post-test scores from the control and intervention groups in each trial, as well as comparing post-test scores from the intervention and control groups in each test. These statistical procedures are predicated on the premise that baseline scores on outcome measures are similar across groups of participants. Although any differences in baseline scores between trials would be limited since all participants were allocated at random, baseline imbalance is still a possibility, especially when the number of patients participating is small, as was the case in this study.
Parametric and non-parametric tests
Because they are dependent on the underlying assumptions that guide them, different statistical tests are classified as either parametric or non-parametric (Mircioiu & Atkinson, 2017). Parametric tests, as the name implies, are statistical tests that make assumptions about the characteristics of the population from which a sample is derived. However, it should be noted that this is often based on the assumption that the data of the population is regularly distributed. The Pearson correlation, the one-way analysis, the paired t-test, and the unpaired t-test of variance are examples of statistical tests that come within the category of parametric tests. Furthermore, non-parametric tests are beneficial when dealing with data that is both normally distributed and non-normally distributed. Non-parametric statistical tests include the Spearman correlation coefficient, the Kruskal-Wallis test, the Wilcoxon Z test, and the Mann-Whitney U test, among others.
Edwards, Walsh, Diment, and Roberts (2018) used parametric tests since there was a distribution of variables. A total of 66 well-versed men completed widely used psychological tests to assess state-anxiety and also perceived psychological stress prior to engaging in vigorous activity. Afterwards, they ran either half an hour at 60 percent or 30 minutes at 40 percent before DPCP sensitization. Li, Liu, Wang, and Smith (2020) use non-parametric tests because they use both English and Chinese data sources to search for randomized controlled trials (RCTs) pertaining to mind-body exercise in patients with COPD who have anxiety that was published 30 years ago. The researchers looked for randomized controlled trials (RCTs) including mind-body training in COPD patients who were also suffering from anxiety and depression. A total of 13 appropriate randomized controlled trials (RCTs) have been included in the meta-analysis, indicating that no physical factors were included in the research.
Aylett, Small, and Bower, (2018) use non-parametric since it reviews randomized controlled trials conducted in a systematic manner. CENTRAL, Medline, and Embase were the three databases that were searched. The outcome evaluation was done using anxiety rating measures that have been verified. The quality of the research was evaluated using the Cochrane Risk of Bias instrument, which was developed by the Cochrane Collaboration. This indicates that there was a normal distribution of variables.
Validity and reliability factors
For the purpose of determining the overall quality of research, the validity and reliability standards are used. They offer an indicator of how well a technique, approach, or test examines something like that in terms of its effectiveness and accuracy. Generally speaking, the validity of a method refers to the precision with which it measures what it intends to measure. The extent to which the results of a study correspond to true qualities, characteristics, as well as changes that exist in the social or physical environment is characterized as the validity of the research. The dependability of a method is referred to as the reliability with which it measures something. If another outcome can be produced consistently by performing the same techniques under the same circumstances over an extended period of time, the assessment is considered reliable. Edwards, Walsh, Diment, and Roberts (2018) conducted valid and reliable research because I got the article from a credible and reliable database. The article by Aylett, Small, and Bower, (2018) is valid and reliable since it described the stages required in data gathering as well as the steps involved in data analysis. The article is also reliable because the research is honest. The article by Li, Liu, Wang, and Smith (2020) is valid because it is thoroughly researched and it has a basis in existing knowledge. The research is also reliable because the results are reproducible, precise, and stable.
Application of the chosen studies
The study by Aylett, Small, and Bower, (2018) is important because it found out that exercise programs might be an effective therapeutic option for those suffering from anxiety disorders. More so, the researchers discovered that exercise regimens with a high level of intensity were shown to be more efficient than exercise regimens with a low level of intensity in the therapeutic option for diabetic patients. Edwards, Walsh, Diment, and Roberts (2018) conducted important research because it indicates that the degrees of perceived psychological stress as well as state anxiety before exercise has an essential role in determining the intensity of the in vivo immune response that occurs as a result of the exercise. The research by Li, Liu, Wang, and Smith (2020) is important because it explains how exercise that incorporates both the mind and the body may help people with COPD feel less anxious and depressed.

References
Aylett, E., Small, N., & Bower, P. (2018). Exercise in the treatment of clinical anxiety in general practice–a systematic review and meta-analysis. BMC health services research, 18(1), 1-18.
Edwards, J., Walsh, N., Diment, B., & Roberts, R. (2018). Anxiety and perceived psychological stress play an important role in the immune response after exercise. Exercise immunology review, 24.
Li, Z., Liu, S., Wang, L., & Smith, L. (2020). Mind-body exercise for anxiety and depression in COPD patients: a systematic review and meta-analysis. International journal of environmental research and public health, 17(1), 22.
Mircioiu, C., & Atkinson, J. (2017). A comparison of parametric and non-parametric methods was applied to a Likert scale. Pharmacy, 5(2), 26.

Assessment Description
Development of the prospectus is an iterative process that lays the foundation for your DPI Project. The prospectus will also assist your project chair in providing valuable feedback to guide you in your project development.

General Requirements:

Use the following information to ensure successful completion of the assignment:

Locate and download the most recent version of the prospectus template in the DC Network (http://dc.gcu.edu/dnp). This document has help and criteria information embedded to assist you in the completion of the prospectus.
Locate “The 10 Strategic Points” document (completed in previous courses). You will use information from this document to write the prospectus and attach this document as an appendix in the prospectus.
Review “DNP-830 Direct Practice Improvement (DPI) Project Guide,” (Chapters 1-3 only) for use in writing the prospectus.
Doctoral learners are required to use the APA style for their writing assignments. The APA Style Guide is located in the Student Success Center.
This assignment uses a rubric. Review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
You are required to submit this assignment to LopesWrite. A link to the LopesWrite technical support articles is located in Course Materials if you need assistance.
Directions:

Complete a draft of your DPI Project prospectus according to the instructions and criteria provided in each section of the prospectus template. The draft should include information taken from “The 10 Strategic Points” document (from previous courses). Use the “DNP-830 Direct Practice Improvement (DPI) Project Guide” (Chapters 1-3 only) to assist you in writing this prospectus. Include the following sections in the prospectus:

Introduction: Provide an overview of your project.
Background of the Problem: Provide an overview of the history and present state of the problem.
Problem Statement: Specify the problem proposed for the project by presenting a clear declarative statement that begins with “It is not known . . . .” Identify the need for the project. Identify the broad population (not the sample) for the project. Describe how this project may contribute to solving the problem.
Purpose of the Project: Describe the purpose of this project. Use a declarative statement “The purpose of this project is to . . . .” Describe the methodology and design. Describe the specific population that this project will affect and how this project will contribute to the field.
Clinical Questions and Variables: Provide a brief introduction to the question portion. State your clinical questions or PICOT questions. Describe and operationally define each variable of interest.
Advancing Scientific Knowledge: Provide a brief overview specifically describing how the project will advance population health outcomes on the topic.
Significance of the Project: Provide an overview of how this project fits with other research in the field. Be specific and relate to other studies. How will this project contribute to the research overall? What is the expected value?
The rationale for Methodology: Clearly justify the methods chosen for this project. Ensure the methods align with the project questions or PICOT questions. Describe why this method is the best fit.
Nature of the Project Design: Describe the design you have chosen for this project. Discuss why this design is appropriate based on the method chosen and the project questions.
Instrumentation or Sources of Data: Describe the sources of data you will use. One source must be a valid and reliable tool, survey, or questionnaire. You may use your discussion question from Topic 3 to assist with this section. Describe in detail all data collection instruments. Describe the validity and reliability of each as appropriate (one must be valid and reliable).
Data Collection Procedures: Describe step by step how you will collect data. All major steps need to be described. Include a discussion of project sample recruitment, sample selection, and assignment to groups (as applicable). Describe the process of obtaining informed consent, if applicable.
Data Analysis Procedures: Begin by describing your demographic data from your participants. How will you analyze this data using descriptive statistics? Restate each project question or PICOT question. For each question, describe in detail what inferential statistics you will use to analyze your data. Include steps to ensure your data meet the assumptions for each inferential statistic used. Describe the a priori alpha level you plan to use.
Ethical Considerations: Provide a description of ethical issues related to your project and how you plan to deal with them. Consider your methodology, design, and data collection. Compare to a randomized controlled trial. Address anonymity, confidentiality, privacy, lack of coercion, informed consent, and potential conflicts of interest. Discuss how you plan to adhere to the Belmont Report key principles (respect, justice, beneficence).
Theoretical Foundations: Identify and describe one or two theories or models to be used to inform the project. Identify the seminal source for each theory or model (a seminal source may be quite old and may be published in a textbook). Illustrate how the theory or model will inform your project.
Review of the Literature Themes/Topics: Describe at least two main themes with at least three subthemes for each of the main themes of your project. Your literature review will eventually be 20-25 pages with over 50 references (85% of these references must be from primary sources that are less than 5 years old).
Portfolio Practice Hours:

Practice immersion assignments are based on your current course objectives and are application-based learning using your real-world practice setting. These assignments earn practice immersion hours and are indicated in the syllabus by a Portfolio Practice Hours statement which reminds you, the learner, to enter in a corresponding case log in Typhon. Actual practice immersion hours are entered, but the average hours associated with each practice immersion assignment is 10.

You are required to complete your assignment using real-world applications. The real-world application requires the use of evidence-based data, contemporary theories, and concepts presented in the course. The culmination of your assignment must present a viable application in a current practice setting. For more information on parameters for practice immersion hours, please refer to DNP resources in the DC Network.

To earn portfolio practice hours, enter the following after the references section of your paper:

Practice Hours Completion Statement DNP-830

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Solution

Draft Prospectus for DNP Direct Practice Improvement (DPI) Project on the Effect of Physical Activity and Exercise on Patients with Generalized Anxiety Disorder (GAD)

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or the DSM-5 places generalized anxiety disorder (GAD) in the diagnostic classification of ‘Anxiety Disorders’. The other conditions in the same class include panic disorder, agoraphobia, social anxiety disorder, and selective mutism amongst others. These disorders share the same presenting features of irrational fear and anxiety (APA, 2013; Sadock et al., 2015). The purpose of this paper is to present a direct practice improvement (DPI) prospectus demonstrating why exercise and general physical activity are preferred as evidence-based interventions for GAD in adults aged 30-55 years old.

Background to the Problem

Generalized anxiety disorder (GAD) is a mental or psychiatric condition that is usually chronic and characteristically affects older persons. Its diagnostic code in the DSM-5 is 300.02 (F41.1) and it is known to normally co-occur with major depression in the same patient. This would usually mask its presentation and sometimes lead to misdiagnosis (APA, 2013; Sadock et al., 2015). Its burden of disease in the United States is immense as the Anxiety and Depression Association of America (ADAA) estimates that 3.1% or about 6.8 million Americans suffer from GAD. Unfortunately, because of a combination of factors that include unfavorable social determinants of health like access to healthcare only about 43.2% of patients get treatment (ADAA, 2021). The female gender is a risk factor for GAD and therefore women have been determined to be twice as likely to develop GAD as men. As Zhang et al. (2015) found, one of the reasons is that females generally have a lower threshold for anxiety.

Problem Statement

It is not known whether exercise and physical activity can replace medications in the treatment of GAD. Anxiety disorders have the dubious distinction of being the most common psychiatric conditions in the United States (ADAA, 2021).  Amongst them, GAD stands out as a major contributor to morbidity among adults. A study conducted by Locke et al. (2015) found it to be very prevalent in the US. A particular important finding by the researchers was that it causes significant impairment in interpersonal relationships, self care, and occupational pursuits. This results to a poor quality of life (QoL) for the patient as they find it difficult to function within the society. This also has a bearing on the patients’ ability to undertake their activities of daily living (ADLs) and therefore inability to care for oneself (Locke et al., 2015).

It has been stated above that less than half of those who suffer from GAD actually eventually receive treatment. Of those that receive treatment, the thinking even among mental health professionals has been that pharmacotherapy is the best treatment for GAD. Often, standard practice is to combine it with psychotherapy in the form of cognitive behavioral therapy of CBT (Stavestrand et al., 2019). However, studies and scholarly evidence has shown that unlike other mental disorders, GAD does not do very well with medications such as anxiolytics. Stavestrand et al. (2019) found in a randomized controlled trial that actually exercise when combined with cognitive behavioral therapy is efficacious in relieving the symptoms of GAD. An interesting finding was that polypharmacy and habituation to medications is a major problem when pharmacotherapy is used to manage GAD in adults. To cement this scholarly evidence for exercise in GAD, Herring et al. (2016) also found in a study that indeed exercise and physical activity in general are effective in controlling symptoms of the disorder.

Purpose of the Project

The purpose of this project is to determine if indeed Stavestrand et al. (2019) and Herring et al. (2016) are correct in finding that exercise is beneficial in treating GAD. The intention is to compare the intervention with that of administering medications to a representative population sample of adults aged 30 years to 55 years old. The most important inclusion criterion will be a DSM-5 diagnosis of GAD. As stated in the PICOT statement, the duration of this clinical inquiry will be a period of three months from start to finish. As with any intervention for a mental health problem, there will be need to assess the level of anxiety at the start of the exercise and also at the end of it for every participant. This will give an indication of whether the exercise intervention has been effective or not. For this, the assessment tool that has been chosen and that is the most appropriate for GAD is the Generalized Anxiety Disorder 7-Item Scale or GAD-7.

Clinical Questions and Variables

Every scholarly investigation or research requires specific questions to guide the investigation. The PICOT question to this clinical inquiry project was: Among adults aged 30-55 years old and diagnosed with generalized anxiety disorder or GAD (P), can exercise and physical activity (I) compared to medications only (C) reduce significantly the GAD-7 anxiety score (O) within a timeframe of twelve weeks (T)? Apart from this PICOT statement, several research questions also inform the methodology and conduct of the clinical inquiry. They include the following:

  • What are some of the benefits of exercise and physical activity compared to medications in terms of side effects?
  • Does the fact that GAD commonly affects older persons mean that they are at a higher risk of drug side effects and interactions due to the effects of aging in the context of polypharmacy?
  • Which is the best combination for the best patient outcomes between exercise-CBT and medications-CBT?

Every quantitative research investigation such as this one must have an independent and a dependent variable. In the experimental setting with the study group of participants, it is the independent variable that is manipulated to see how the dependent variable will behave. For the purposes of this project, the independent variable will be the administration of exercise/ physical activity and/ or anxiolytic medications/ CBT to the experimental cohort of participants diagnosed with GAD. On the other hand, the dependent variable will be the reduction or otherwise of the GAD symptoms as assessed by means of the GAD-7 anxiety scores.

Advancing Scientific Knowledge

The expected end result of this project is to influence and improve the current body of evidence-based practice (EBP) with regard to the management of generalized anxiety disorder as a mental illness. In other words, the project aims to advance the population health outcomes of patients suffering from GAD and requiring efficacious interventions devoid of clinical disadvantages. After hopefully getting positive results, the recommendations of this project will be disseminated to all mental health professionals including psychiatric-mental health nurse practitioners or PMHNPs. The hope is that they will translate the findings into practice by doing way with the common practice of prescribing medications and embracing exercise prescription together with CBT psychotherapy. Current nursing and medical practice is guided by evidence or best practice. Because of this, the project adopts a scientific approach of clinical inquiry to come up with incontrovertible scholarly evidence to guide practice. If the GAD-7 scores fall as expected at the end of the project, the population health outcomes of GAD patients will be significantly advanced as the same intervention will be applied across the board for GAD.

Significance of the Project

The significance of this project cannot be underestimated. It will provide a major scholarly boost to the corroboration of the findings of other scholars who have indicated that exercise is an alternative intervention to drugs in treating GAD. The project snugly fits with other similar research efforts that have been undertaken before. Stavestrand et al. (2019) came up with the PEXACOG paradigm after a successful randomized controlled trial. They found that physical exercise and cognitive behavioral therapy (PEXACOG) is efficacious in reducing the symptoms of GAD. They also indicated that their trial showed that polypharmacy and habituation to medications were significant risks when medications are used to manage GAD. Herring et al. (2016) also got similar findings when they applied exercise therapy to patients suffering from GAD.

This project will therefore contribute to research overall in that it will add to the available literature that provides scholarly evidence in support of exercise and physical activity in the management of GAD in adults. Currently, there is a paucity of literature on the subject and so the outcome of this project will be a huge scholarly boost and a win for evidence-based practice (EBP). Other researchers will in future be able to quote, cite, and refer to the findings of this project in support of their argument for exercise and physical activity in treating GAD. The expected value of the research will therefore be scholarly enrichment and evidentiary support for practice.

The Rationale for Methodology

This project will be experimental in nature with the sample of participants divided into a study (experimental) group and a control group. The study group will be given the intervention under investigation to see if there will be a change in the dependent variable or outcome. The rationale for this methodology is that the project aims to establish causality and experimentation is the best way to determine that. This methodology aligns very well with the research questions and PICOT statement as it is designed to specifically address them. For instance, the PICOT question asks whether exercise is better compared to medications alone. The experimental group of the sample is then given exercise treatment to see if their anxiety scores on the GAD-7 tool will drop. This method is therefore the best fit because it has the potential of definitively determining the veracity of the claim that physical activity helps in reducing anxiety.

Nature of the Project Design

This project has been designed as a clinical inquiry that begins by stating a PICOT question. The appropriateness of this design is in the fact that its motive is to improve current practice from common practice to best practice. As a clinical inquiry project, this design of the project facilitates the answering of the research and PICT questions in a systematic manner. Part of the answers will come from a search of research databases for peer-reviewed scholarly evidence that was published before the current project.

Instrumentation or Sources of Data

This project will use as a source of data a simplified Likert-type questionnaire that will be used to gather data from the participants. The choice of a Likert scale is informed by the fact that it will be easy to analyze this data using both parametric and non-parametric tests of inference. The questionnaire instrument will have direct but short questions to which the participants have to respond by using a scale. The scale is graded as ‘totally disagree,’ ‘disagree,’ ‘neutral,’ ‘agree,’ and ‘totally agree.’ All the respondents will have to do is to choose the most appropriate statement on the scale and tick it. This makes it easy and fast to fill and therefore saves time.

Reliability is the consistency of the data collection tool. Essentially what this means is that the questionnaire as used in this project will measure the same parameters even if they were repeated another time in the same circumstances. On the other hand, study validity refers to how well the results obtained from the sample of participants match with the parameters found in the larger population. Reliability and validity enable generalizability of findings to the entire population after the results are concluded. Testing-retesting was used to determine the reliability of the questionnaire; while piloting was carried out to ensure that it was valid.

Data Collection Procedures

Collection of data for this project will take place in two phases. The first one will be at the start of the project and the aim will be to gather baseline data with which the final data will be compared. Then the second phase of data collection will occur at the end of the project timeline. A nurse will pose or read the questions to the participant and give them the scale options available for them to choose as an answer. They will repeat the question and the choices twice so that the patient can understand well. After filling all the questionnaires, the data will then be tabulated and entered into a spreadsheet ready for analysis.

The recruitment of participants will happen from among the patients being seen at the mental health clinic. This will be a convenience sample but the selection of the exact number of participants will be random. Assignment to either the study group or the control group will also be entirely random. Inclusion criteria will include age between 30 and 55 years, a diagnosis of GAD by a certified mental health clinician, and absence of co-occurring major depression. Exclusion criteria include age below 30 years and above 55 years, presence of comorbidity with major depressive disorder (MDD), and presence of substance abuse. For the sample of patients that will agree to participate, they will have to sign a consent form after receiving detailed explanation of the reasons for the project and the benefits that they stand to gain by participating in it.

Data Analysis Procedures

The demographic data of the participants were that they had to be aged between 30 and 55 years, either male or female. Data analysis will then take place to provide answers to the research questions posed at the start as well as the PICOT question. Descriptive parametric statistics such as means, standard deviation, and percentages will be calculated. Also, strong nonparametric tests will be used in order for inferences to be drawn scientifically. Some of those that are appropriate in the case of this project are Chi-square test of significance, linear regression, and analysis of variance or ANOVA.

To restate the PICOT question, what intervention between exercise and medications can reduce the symptoms of GAD effectively within 12 weeks? The inferential statistical test that may be used successfully in this case is the Chi-square test of significance. This test will aim to determine if a relationship actually exists between the practice of exercise as an intervention and the reduction in the symptoms of GAD. The data will be entered in a contingency table as expected and observed values and the decision criterion will be to reject the null hypothesis (no relationship) if the computed χ2 value is greater than the hypothesized or critical value. The alpha level used will be α = 0.05 and the significance level will be 5%.

Ethical Considerations

The most important ethical issues for this project are autonomy, beneficence, nonmaleficence, and justice (Haswell, 2019). The informed consent form assures autonomy after explanation to the participants. However, the conduct of the project has to be such that no harm or injury befalls the patients because of the interventions (nonmaleficence). Direct benefit has also to be seen as coming to the patients who agreed to participate (beneficence). Last but not least, all the participants must be treated equally and justly irrespective of race/ ethnicity, creed, color, religion, or sexual orientation. All these will ensure that the Belmont Report is respected (OHRP, 2018). This project with its methodology, design, and data collection is comparable to the randomized controlled trial conducted by Stavestrand et al. (2019).

Privacy and confidentiality of the information and data collected will be guaranteed by not writing the names of the participants. This will also ensure anonymity all the time. To prevent the aspect of coercion (even if passive), the consent form will state clearly that any participant can withdraw their consent at any time during the project without seeking permission from anyone. No physical therapist who could potentially benefit from the exercise prescription will take part in the exercise to prevent potential conflict of interest.       

Theoretical Foundations

Roger’s diffusion of innovations model will inform the implementation of this project (Dearing & Cox, 2018). This theory will inform the project in that the first step will be enlightening the target population of clinicians about the need for the change, the second will be persuading them to gain buy-in, the third will be deciding to go ahead with the project, the fourth to implement, and the fifth to confirm the practice as part of organizational policy.

Review of the Literature Themes/ Topics

The two main themes from this project are:

  1. Safe but effective intervention for GAD
  2. Long-term remission without symptoms or side effects.

Three sub-themes that can be deduced from the above two themes are:

  • The cost-effectiveness of exercise.
  • The ease of availability of exercise.
  • The disadvantage of medications with regard to side effects.

Conclusion

GAD as a mental health condition is a debilitating illness that ravages populations and significantly renders victims dysfunctional. The burden of disease in the United States is huge. Unfortunately, most of the sick do not usually even get treatment. Traditionally, treatment for those who access it is in the form of pharmacotherapy and sometimes psychotherapy. This prospectus has demonstrated that exercise and physical activity in general is an evidence-based alternative that is not only cost-effective but also readily available even for the patient themselves.

 

 

 

Appendix

10 Strategic Points Table

(Use this table to complete the 10 Strategic Points document for your project.)

The 10 Strategic Points
Broad Topic Area 1.      Broad Topic Area/Title of Project:

 

Literature Review 2.      Literature Review:

a.      Background of the Problem/Gap:

b.      Theoretical Foundations (models and theories to be foundation for the project):

c.       Review of Literature with Key Organizing Themes and Sub-themes  (Identify at least two themes, with three sub-themes per theme)

Theme 1 (placeholder only; name theme):

     Sub-theme 1 Grouped findings related to Theme 1

     Sub-theme 2

    Sub-theme 3

d.      Summary

·         Gap/Problem:

·         Prior studies:

·         Quantitative application:

Significance:

Problem Statement 3.      Problem Statement:

It was not known if or to what degree the implementation of __________________would impact ______________ when compared to _______________ among ___________ (population).

 

Clinical/
PICOT Questions
4.      Clinical/PICOT Questions:

To what degree does the implementation of _______________ (intervention) impacts __________________ (what) when compared to _____________ among _____________ (population) patients in a ______ (setting) in _______ (state) over four-weeks?

Sample 5.      Sample (and Location):

a.   Location: Urban/Rural (State)

b.   Population (Participants)

c.   Sample: Specify the sample size desired and perform a power analysis if appropriate.

d.   Inclusion Criteria

§  Who can participate?

 

e.   Exclusion Criteria

§  Who cannot participate?

 

Define Variables 6.      Define Variables and Level of Measurement:

a.       Independent Variable (Intervention):

 

b.      Dependent Variable:

Methodology and Design Methodology and Design:

 

Purpose Statement Purpose Statement:

The purpose of this quantitative, quasi-experimental project was to determine if or to what degree the implementation of _________________ (intervention) would impact ______________(what) when compared to _______________________ among ___________(population)  in a ________ (setting ie: primary care clinic, ER, OR) in ________ (state) ___ time.

 

Data Collection Approach Data Collection Approach:

 

Data Analysis Approach Data Analysis Approach:

 

References

 

APA formatted sources.

·         Original Research Article

·         Original Research Article

·          

 

 

Criterion Learner Score
(0, 1, 2, or 3)
Chairperson Score
(0, 1, 2, or 3)
Comments or Feedback
10 Strategic points

 

Topic: Provides a broad project topic area/title.      
Literature Review: Lists primary points for four sections in the Literature Review: (a) Background of the problem/gap and the need for the project based on evidence from the literature; (b) Theoretical foundations (models and theories to be foundation for project); (c) Review of literature topics with at least two organizing themes and three sub-themes for each theme (d) Summary.

Minimum number of themes and sub-themes met per course requirement and

Did they meet the minimum article count for original research?

     
Problem Statement: Describes the problem in a single declarative sentence to address through the project based on defined gaps or needs from the literature.      
Sample and Location: Identifies sample, needed sample size, location, and inclusion and exclusion criteria.      
Clinical/PICOT Questions: Provides clinical/PICOT questions to all of the collected data needed to address the problem statement.      
Variables: Provides variables for each project PICOT question component.      
Methodology and Design: Describes the selected methodology and specific research design to address problem statements and clinical/PICOT questions.      
Purpose Statement: Provides a one-sentence statement of purpose including the problem statement, methodology, design, population sample, and location.      
Data Collection: Describes primary instruments and sources of data to answer research questions. Reliability and Validity of the instruments are addressed.      
Data Analysis: Describes the specific data analysis approaches to be used to address clinical/PICOT questions. The statistical test(s) that will be used must be identified and must be appropriate for the level of data and the clinical/PICOT question.      
NOTE: Once the document has been approved by your chairperson and your committee and is ready to submit for AQR review, please remove all of these assessment tables from this document.

Score 0 (not present); 1 (unacceptable; needs substantial edits); 2 (present, but needs some editing); 3 (publication ready).

 References

American Psychological Association [APA] (2013). Diagnostic and Statistical Manual of Mental Disorders (DSM-5), 5th ed. Author.

Anxiety and Depression Association of America [ADAA] (2021). Understand anxiety and depression: Facts and statistics. https://adaa.org/understanding-anxiety/facts-statistics

Dearing, J.W. & Cox, J.G. (2018). Diffusion of innovations theory, principles, and practice. Health Affairs, 37(2), 183-190. http://dx.doi.org/10.1377/hlthaff.2017.1104

Haswell, N. (2019). The four ethical principles and their application in aesthetic practice. Journal of Aesthetic Nursing, 8(4), 177-179. https://doi.org/10.12968/joan.2019.8.4.177

Herring, M.P., Johnson, K.E., & O’Connor, P.J. (2016). Exercise training and health related quality of life in generalized anxiety disorder. Psychology of Sport and Exercise, 27, 138- 141. https://doi.org/10.1016/j.psychsport.2016.08.011  

Locke, A., Kirst, N., & Shultz, C.G. (2015). Diagnosis and management of generalized anxiety disorder and panic disorder in adults. American family physician91(9), 617-624. https://www.aafp.org/afp/2015/0501/p617.html

Office for Human Research Protections [OHRP] (January 15, 2018). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Sadock, B.J., Sadock, V.A., & Ruiz, P. (2015). Synopsis of psychiatry: Behavioral sciences clinical psychiatry, 11th ed. Wolters

Stavestrand, S. H., Sirevåg, K., Nordhus, I. H., Sjøbø, T., Endal, T. B., Nordahl, H. M., … & Andersson, E. (2019). Physical exercise augmented cognitive behaviour therapy for older adults with generalized anxiety disorder (PEXACOG): Study protocol for a randomized controlled trial. Trials, 20(1), 1-14. https://doi.org/10.1186/s13063-019-3268-9

Zhang, X., Norton, J., Carrière, I., Ritchie, K., Chaudieu, I., & Ancelin, M-L. (2015). Risk factors for late-onset generalized anxiety disorder: Results from a 12-year prospective cohort (The ESPRIT study). Translational Psychiatry, 5(e536), 1-8. http://dx.doi.org/10.1038/tp.2015.31

 

 

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